exelan pharmaceuticals, inc - Medication Listings

Browse 63 medications manufactured by exelan pharmaceuticals, inc. Open a product record to review dosage forms, strengths, packaging, and related navigation.

LISINOPRIL LISINOPRIL
#2 2.5 mg Tablet
EXELAN PHARMACEUTICALS, INC FDA Rx Only

Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is: Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients: 2.5 mg tablets – anhydrous lactose, magnesium stearate. 5 mg, 10 mg, 20 mg and 30 mg tablets – anhydrous lactose, magnesium stearate, iron oxide red. 40 mg tablets – anhydrous lactose, magnesium stearate, iron oxide yellow. Lisinopril structure.jpg

lisinopril LISINOPRIL
#2 2.5 mg Tablet
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N 2 -(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C 21 H 31 N 3 O 5 2H 2 O and its structural formula is: Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients: 2.5 mg tablets - lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate. 5 mg, 10 mg, 20 mg and 30 mg tablets – lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, iron oxide red. 40 mg tablets - lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, iron oxide yellow. Chemical Structure

Amlodipine besylate AMLODIPINE BESYLATE
#5 2.5 mg Tablet
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20 H 25 CIN 2 O 5 •C 6 H 6 O 3 S, and its structural formula is: Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate. structure

Amlodipine besylate AMLODIPINE BESYLATE
#5 2.5 mg Tablet
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20 H 25 CIN 2 O 5 •C 6 H 6 O 3 S, and its structural formula is: Amlodipine Besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5 mg, 5 mg, or 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. USP dissolution test pending structure

ALBUTEROL SULFATE ALBUTEROL SULFATE
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

The active component of Albuterol sulfate inhalation aerosol is albuterol sulfate, USP racemic α 1 [( tert- Butylamino)methyl]-4-hydroxy- m -xylene-α,α'-diol sulfate (2:1)(salt), a relatively selective beta 2 -adrenergic bronchodilator having the following chemical structure: Albuterol sulfate is the official generic name in the United States. The World Health Organization recommended name for the drug is salbutamol sulfate. The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C 13 H 21 NO 3 ) 2 •H 2 SO 4 . Albuterol sulfate is a white to off-white crystalline solid. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate inhalation aerosol is a pressurized metered-dose aerosol unit for oral inhalation. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane), ethanol, and oleic acid. Each actuation delivers 120 mcg albuterol sulfate, USP from the valve and 108 mcg albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). Each canister provides 200 inhalations. It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four "test sprays" into the air, away from the face. This product does not contain chlorofluorocarbons (CFCs) as the propellant. Image

GABAPENTIN GABAPENTIN
#11 600 mg Tablet
EXELAN PHARMACEUTICALS INC. FDA Rx Only

The active ingredient in gabapentin tablets is gabapentin, USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9 H 17 NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is: Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin tablets, USP are white colored film coated, modified capsule shaped biconvex tablets containing 600 mg and 800 mg of gabapentin, USP. The inactive ingredients are mannitol, Hydroxypropyl Cellulose, Crospovidone, Talc, Magnesium stearate and aquarius ® BP18114 Cool Vanilla. Structure

GABAPENTIN GABAPENTIN
#11 100 mg Capsule
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9 H 17 NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is: Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at p H 7.4 is –1.25. Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. gabapentin-capsules-str.jpg

GABAPENTIN GABAPENTIN
#11 600 mg Tablet
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

The active ingredient in gabapentin tablets is gabapentin, USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9 H 17 NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is: Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: mannitol, hydroxypropyl cellulose, crospovidone, talc, silicon dioxide, glyceryl dibehenate, and magnesium stearate. struc

Hydrochlorothiazide HYDROCHLOROTHIAZIDE
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro- 2H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula: Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n -butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: corn starch, FD&C Yellow #6, dibasic calcium phosphate, pregelatinized starch, colloidal silicon dioxide, lactose monohydrate and magnesium stearate. hydrochlorothiazide-structure

SERTRALINE SERTRALINE
#15 25 mg Tablet
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Sertraline contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2•HCl is represented by the following structural formula: Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline tablets, USP for oral administration are supplied as scored tablets containing 27.98 mg, 55.9 mg and 111.9 mg sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, polysorbate 80, D&C Yellow #10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25 mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100 mg tablet) and sodium starch glycolate. Chemical Structure

Cyclobenzaprine Hydrochloride CYCLOBENZAPRINE
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C 20 H 21 N•HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK a of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5 ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula: Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80). structure

Ibuprofen IBUPROFEN
#25 400 mg
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-( p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below: Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide. image description

SILDENAFIL SILDENAFIL
#28 25 mg Tablet
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Sildenafil tablets, USP an oral therapy for erectile dysfunction, is the salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1Hpyrazolo[ 4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine and has the following structural formula: Sildenafil is a white to almost-white crystalline powder with a solubility of 4.95 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets, USP are formulated as white, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil , each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. Figure 1

Meloxicam MELOXICAM
#30 7.5 mg Tablet
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Meloxicam Tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-­carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14 H 13 N 3 O 4 S 2 and it has the following structural formula: Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate. Chemical Structure

CITALOPRAM HYDROBROMIDE CITALOPRAM
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Citalopram tablet contains citalopram hydrobromide, an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3- dihydroisobenzofuran-5-carbonitrile, hydrobromide with the following structural formula: The molecular formula is C 20 H 22 BrFN 2 O and its molecular weight is 405.35. Citalopram hydrobromide occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram is available only in tablet dosage form. Citalopram tablets, USP 10 mg are film-coated, round tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, round, scored tablets containing citalopram hydrobromide in strengths equivalent to 20 mg or 40 mg citalopram base. Their strengths reflect their citalopram base equivalent content. The 10 mg, 20 mg and 40 mg strength tablets contain 12.49 mg, 24.98 mg and 49.96 mg of citalopram hydrobromide, respectively. The tablets also contain the following. Inactive ingredients : copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry beige (HPMC 2910/hypromellose 6cp, titanium dioxide, macrogol/Peg400, iron oxide yellow and iron oxide red), opadry pink (HPMC 2910/hypromellose 6cP, titanium dioxide, macrogol/Peg400 and iron oxide red) and opadry white (titanium dioxide, HPMC 2910/hypromellose 3cp, HPMC 2910/ hypromellose 6cp, Macrogol/Peg400 and Polysorbate 80) are used as coloring agents in the beige (10 mg) and pink (20 mg) and white (40 mg) tablets. Image

Escitalopram oxalate ESCITALOPRAM
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Escitalopram tablets, USP is a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3(dimethyl-amino)propyl]-1-( p -fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula: The molecular formula is C 20 H 21 FN 2 O • C 2 H 2 O 4 and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets USP, are film-coated, round tablets containing 6.38 mg, 12.75 mg, 25.50 mg oxalate in strengths equivalent to 5 mg, 10 and 20 mg, respectively, of base. The 10 mg and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, croscarmellose sodium, talc, magnesium stearate, Opadry white (titanium dioxide, hypromellose 3cP, hypromellose 6cP, macrogol and polysorbate 80). esc8

Naproxen NAPROXEN
#49 250 mg Tablet
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Naproxen tablets, USP are nonsteroidal anti-inflammatory drugs available as follows: Naproxen tablets, USP are available as yellow tablets containing 250 mg of naproxen USP, pink tablets containing 375 mg of naproxen USP, and yellow tablets containing 500 mg of naproxen USP for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . It has the following structural formula: Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The inactive ingredients are croscarmellose sodium, povidone, iron oxide yellow, iron oxide red colloidal silicon dioxide and magnesium stearate. Structural Formula

ALENDRONATE SODIUM ALENDRONATE SODIUM
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C 4 H 12 NNaO 7 P 2 •3H 2 O and its formula weight is 325.12. The structural formula is: Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet, for oral administration contains: 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate and starch. 1

Alfuzosin hydrochloride ALFUZOSIN HYDROCHLORIDE
10 mg Extended-release
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Each alfuzosin hydrochloride extended-release tablet, USP contains 10 mg alfuzosin hydrochloride as the active ingredient. Alfuzosin hydrochloride is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride, USP is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The empirical formula of alfuzosin hydrochloride is C 19 H 27 N 5 O 4 •HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is: The tablet also contains the following inactive ingredients: microcrystalline cellulose (NF), guar gum (NF), hydroxypropyl methyl cellulose (USP), colloidal silicon dioxide (NF) and magnesium stearate (NF). Meets USP Dissolution Test 4 dia1

Aripiprazole ARIPIPRAZOLE
2 mg Tablet
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Aripiprazole is a psychotropic drug that is available as aripiprazole tablets. Aripiprazole tablets are chemically designated as 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone. The empirical formula is C 23 H 27 Cl 2 N 3 O 2 , and molecular weight is 448.39. The chemical structure is as follows: Aripiprazole tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. Structure

Budesonide Inhalation Suspension BUDESONIDE
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as (RS)-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C 25 H 34 O 6 and its molecular weight is 430.5. Its structural formula is: Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 10 3 . Budesonide inhalation suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients disodium edetate, sodium chloride, sodium citrate dihydrate, citric acid monohydrate, polysorbate 80, and Water for Injection. Three dose strengths are available in single-dose ampules (ampules): 0.25 mg, 0.5 mg, and 1 mg per 2 mL ampule. For budesonide inhalation suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitro conditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. Budesonide inhalation suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see Dosage and Administration ( 2 ) ]. image 1

Bumetanide BUMETANIDE
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Bumetanide is a loop diuretic available as 0.5 mg, 1 mg and 2 mg tablets for oral administration; each tablet also contains lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch. Chemically, 3-Butylamino-4-phenoxy-5-sulphamoylbenzoic Acid. It is a practically white crystalline powder having a calculated molecular weight of 364.42, and the following structural formula: C 17 H 20 N 2 O 5 S The product meets USP Dissolution Test 2. structure

Bupropion Hydrochloride (XL) BUPROPION HYDROCHLORIDE
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Bupropion hydrochloride, USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg, white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: hydroxyl propyl methyl cellulose, microcrystalline cellulose, povidone, citric acid monohydrate, colloidal silicon dioxide, magnesium stearate, methacrylic acid copolymer, talc, titanium dioxide, colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate and triethyl citrate. Meets USP Dissolution Test 18. structure

Calcium Acetate CALCIUM ACETATE
667 mg Capsule
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Calcium acetate acts as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C 4 H 6 CaO 4 , and its molecular weight is 158.17. Its structural formula is: Each capsule is of size ‘00el’ hard gelatin capsule shell with blue opaque cap and white opaque body imprinted with “667 mg” on cap and “IG 377” on body in black ink filled with white to off white powder. Each capsule contains 667 mg calcium acetate, USP (anhydrous; Ca(CH 3 COO) 2 ; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium. Each capsule contains the following inactive ingredients: Sodium Lauryl Sulfate and Sodium Stearyl Fumarate. The gelatin cap and body have the following inactive ingredients: FD&C blue #1, FD&C red #3, titanium dioxide, USP, gelatin, USP and iron oxide black. Calcium acetate capsules are administered orally for the control of hyperphosphatemia in end stage renal failure. “the drug product meets USP Dissolution Test 4” Chemical Structure

CINACALCET CINACALCET
30 mg Tablet
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Cinacalcet hydrochloride tablets contain the hydrochloride salt of cinacalcet, a positive modulator of the calcium sensing receptor. The empirical formula for cinacalcet is C 22 H 22 F 3 N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white, crystalline solid that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula: Cinacalcet hydrochloride tablets are formulated as light-green, film-coated, oval-shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive Ingredients The following are the inactive ingredients in cinacalcet hydrochloride tablets: pre-gelatinized starch (botanical source is maize starch), microcrystalline cellulose, povidone, crospovidone, magnesium stearate and isopropyl alcohol. Tablets are coated with Opadry II Green (hypromellose, lactose monohydrate, titanium dioxide, triacetin, FD&C blue #2/indigo carmine AL, iron oxide yellow). Image

darunavir DARUNAVIR
600 mg Tablet
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Darunavir, in the form of darunavir hydrate, has the following chemical name: [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]-carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester hydrate. Its molecular formula is C 27 H 37 N 3 O 7 S • 2.5H 2 O and its molecular weight is 592.67. Darunavir hydrate has the following structural formula: Darunavir hydrate is a white to off-white crystalline powder which is soluble in methanol and freely soluble in acetone and dimethylsulfoxide. Darunavir 600 mg tablets are available as beige, capsule-shaped, biconvex, film coated tablets for oral administration. Each 600 mg tablet contains darunavir hydrate equivalent to 600 mg of darunavir. Darunavir 800 mg tablets are available as white to off-white, capsule-shaped, biconvex, film coated tablets for oral administration. Each 800 mg tablet contains darunavir hydrate equivalent to 800 mg of darunavir. Each tablet also contains the inactive ingredients microcrystalline cellulose, crospovidone, colloidal silicon dioxide, and magnesium stearate. The 800 mg tablet also contains povidone. The 600 mg tablets are film coated with OPADRY ® II 85F570242 Beige, contains FD&C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablets are film coated with OPADRY ® White 85F28751, contains, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. All dosages for darunavir hydrate are expressed in terms of the free form of darunavir. Image

Diclofenac Sodium DICLOFENAC SODIUM
EXELAN PHARMACEUTICALS INC. FDA OTC

USES for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.

Dofetilide DOFETILIDE
125 mcg
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is The chemical name for dofetilide is: N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]-methanesulfonamide. Dofetilide is a white to off-white powder. It is very slightly soluble in water and propan-2-ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. Dofetilide capsules contain the following inactive ingredients: colloidal silicon dioxide, corn starch, gelatin, magnesium stearate, microcrystalline cellulose and titanium dioxide. The 125 mcg capsules contain FD & C Yellow # 6 and D & C yellow # 10. The 250 mcg and 500 mcg capsules contain FD & C Yellow # 6 and FD& C Red # 40. Dofetilide is supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules. In addition, capsule printing ink contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac glaze. STRUCTURE.jpg

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine: The chemical name of FTC is 5-fluoro-1-(2 R ,5 S )-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C 8 H 10 FN 3 O 3 S and a molecular weight of 247.24. It has the following structural formula: FTC is a white to off-white crystalline powder with a solubility of approximately 112 mg/mL in water at 25°C. The partition coefficient (log p) for emtricitabine is -0.43 and the pKa is 2.65. Tenofovir Disoproxil Fumarate: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[( R )-2 [[bis[[(isopropoxycarbonyl)oxy]- methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C 19 H 30 N 5 O 10 P • C 4 H 4 O 4 and a molecular weight of 635.52. It has the following structural formula: Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25 °C. The partition coefficient (log p) for tenofovir disoproxil is 1.25 and the pKa is 3.75. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration. Each film-coated tablet contains 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate, (which is equivalent to 245 mg of tenofovir disoproxil), as active ingredients. The tablets also include the following inactive ingredients: Lactose Monohydrate, Croscarmellose Sodium, Microcrystalline Cellulose, Pregelatinized Starch, Magnesium Stearate, Opadry Blue II 32K505061 which contains Lactose monohydrate, hypromellose, titanium dioxide, triacetin, FD&C Blue #2 Aluminium lake. Image Image

Finasteride FINASTERIDE
5 mg Tablet
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Finasteride USP, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-,(5α,17β)-. The empirical formula of finasteride is C 23 H 36 N 2 O 2 and its molecular weight is 372.55. Its structural formula is: Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water. Finasteride tablets USP for oral administration are film-coated tablets that contain 5 mg of finasteride and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, docusate sodium, magnesium stearate, opadry blue (FD&C Blue # 2 aluminum lake, hypromellose, talc, titanium dioxide, yellow iron oxide). The botanical source of the Pregelatinized Starch is Maize. MM1

Fosinopril sodium FOSINOPRIL SODIUM
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Fosinopril sodium tablet, USP is the sodium salt of fosinopril USP, the ester prodrug of an angiotensin converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin converting enzyme. Fosinopril sodium, USP is designated chemically as:L-proline,4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-. Fosinopril sodium,USP is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is: Its empirical formula is C 30 H 45 NNaO 7 P, and its molecular weight is 585.65. Fosinopril Sodium, USP is available for oral administrations as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: crospovidone, lactose, microcrystalline cellulose, magnesium stearate, and povidone. Chemical Structure

Gemfibrozil GEMFIBROZIL
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Gemfibrozil, USP is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, NF; croscarmellose sodium, NF; calcium stearate, NF; microcrystalline cellulose, NF; methylcellulose, USP and opadry white. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula: The empirical formula is C 15 H 22 O 3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions. image

HydrALAZINE Hydrochloride HYDRALAZINE HYDROCHLORIDE
EXELAN PHARMACEUTICALS INC. FDA Rx Only

HydrALAZINE Hydrochloride Tablets USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is: HydrALAZINE hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg HydrALAZINE Hydrochloride, USP. Tablets also contain microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, FD&C Yellow #6 and stearic acid.

Lamivudine and Zidovudine LAMIVUDINE AND ZIDOVUDINE
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Lamivudine and Zidovudine Tablets, USP: Lamivudine and Zidovudine Tablets, USP are combination tablets containing lamivudine and zidovudine. Lamivudine and zidovudine (azidothymidine, AZT, or ZDV) are synthetic nucleoside analogues with activity against HIV-1. Lamivudine and Zidovudine Tablets, USP are for oral administration. Each film-coated tablet contains 150 mg of lamivudine USP, 300 mg of zidovudine USP, and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide. Lamivudine: The chemical name of lamivudine is 2(1H) - Pyrimidinone, 4-amino-1- [2- (hydroxymethyl)-1,3-oxathio-lan-5-yl], (2R-cis)-. It has a molecular formula of C 8 H 11 N 3 O 3 S and a molecular weight of 229.26. It has the following structural formula: Lamivudine is white to an off-white solid. Soluble in water. Zidovudine: The chemical name of zidovudine is Thymidine, 3’-azido-3’-deoxy-. It has a molecular formula of C 10 H 13 N 5 O 4 and a molecular weight of 267.24. It has the following structural formula: Zidovudine is a white to yellowish powder. Sparingly soluble in water and soluble in alcohol. This product meets USP Dissolution Test 2. Lamivudine Chemical Structure Zidovudine Chemical Structure

LANREOTIDE ACETATE LANREOTIDE ACETATE
60 mg/0.2 ml Injection
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Lanreotide Injection 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL is a prolonged-release formulation for deep subcutaneous injection. It contains the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occurring somatostatin, water for injection and acetic acid (for pH adjustment). Lanreotide Injection is available as sterile, ready-to-use, single-dose prefilled syringes containing lanreotide acetate supersaturated bulk solution of 24.6% w/w lanreotide base. Each syringe contains: LANREOTIDE ACETATE LANREOTIDE ACETATE LANREOTIDE ACETATE 60 mg/0.2 mL 90 mg/0.3 mL 120 mg/0.5 mL Lanreotide acetate 74.9 mg 108.2 mg 141.5 mg Acetic Acid q.s. q.s. q.s. Water for injection 196.8 mg 284.5 mg 372.1 mg Total Weight 273.9 mg 395.9 mg 517.8 mg Lanreotide acetate is a synthetic cyclical octapeptide analog of the natural hormone, somatostatin. Lanreotide acetate is chemically known as [cyclo S-S]-3-(2-naphthyl)-D-alanyl-L-cysteinyl-L- tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide, acetate salt. Its molecular weight is 1096.34 (base) and its amino acid sequence is: The Lanreotide Injection in the prefilled syringe is a white to pale yellow, semi-solid formulation. Lanreotide structure

Lanthanum carbonate LANTHANUM CARBONATE
500 mg Tablet
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Lanthanum carbonate chewable tablets contains lanthanum carbonate with molecular formula La 2 (CO3) 3 and molecular weight 457.8 (anhydrous mass). Lanthanum carbonate is described as white to almost-white powder. Lanthanum carbonate is practically insoluble in water and is insoluble in organic solvents; it dissolves in dilute mineral acids with effervescence. Each lanthanum carbonate chewable tablet, off-white to yellowish, chewable tablet contains lanthanum carbonate equivalent to 500, 750, or 1,000 mg of elemental lanthanum and the following inactive ingredients: microcrystalline cellulose, guar gum, sucralose, hydroxypropyl cellulose, dextrates, colloidal silicon dioxide, stearic acid, magnesium stearate.

lenalidomide LENALIDOMIDE
5 mg Capsule
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2 H -isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure: 3-(4-amino-1-oxo 1,3-dihydro-2 H -isoindol-2-yl) piperidine-2,6-dione The empirical formula for lenalidomide is C 13 H 13 N 3 O 3 , and with relative molecular mass 259.26 a.m.u. Lenalidomide is an off-white to pale-yellow solid powder. It is freely soluble in dimethyl formamide and practically insoluble in water, diethyl ether, ethanol, and buffered aqueous solvents. Solubility was significantly lower in buffers, ranging from 1.2 to 6.8 as 0.01g in 100 mL. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide capsules are available in 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 10 mg capsule shell contains gelatin, yellow iron oxide, indigotine FD&C Blue # 2, titanium dioxide, and black ink. The 15 mg capsule shell contains gelatin, indigotine FD&C Blue # 2, titanium dioxide, and black ink. The 20 mg capsule shell contains gelatin, yellow iron oxide, FD&C Blue # 2, titanium dioxide, and black ink. The imprinting ink for 5 mg, 10 mg, 15 mg and 25 mg contains black iron oxide, potassium hydroxide, propylene glycol, purified water, and shellac. The imprinting ink for 20 mg contains black iron oxide, D & C yellow # 10, FD & C blue # 1, FD & C blue # 2, FD & C red # 40, and propylene glycol and shellac glaze. Image

LENALIDOMIDE LENALIDOMIDE
2.5 mg Capsule
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2 H -isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure: 3-(4-amino-1-oxo 1,3-dihydro-2 H -isoindol-2-yl) piperidine-2,6-dione The empirical formula for lenalidomide is C 13 H 13 N 3 O 3 , and with relative molecular mass 259.26 a.m.u. Lenalidomide is an off-white to pale-yellow solid powder. It is freely soluble in dimethyl formamide and practically insoluble in water, diethyl ether, ethanol and buffered aqueous solvents. Solubility was significantly lower in buffers, ranging from 1.2 to 6.8 as 0.01g in 100 mL. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide is available in 2.5 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The 2.5 mg capsule shell contains FD&C Blue # 2, gelatin, titanium dioxide, and yellow iron oxide. The imprinting ink of 2.5 mg contains black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. image description

Levetiracetam LEVETIRACETAM
250 mg Tablet
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Levetiracetam tablets, USP is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow) and 750 mg (pink) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8 H 14 N 2 O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) Levetiracetam tablets contain the labeled amount of levetiracetam. Inactive ingredients: Corn starch, povidone, colloidal silicon dioxide, talc, magnesium stearate, and additional agents listed below: 250 mg tablets Opadry Blue (hydroxypropyl methylcellulose, polyethylene glycol 4000, titanium dioxide FD&C Blue #2 Indigo and Carmine Aluminum Lake) 500 mg tablets Opadry Yellow (hydroxypropyl methylcellulose polyethylene glycol 4000 titanium dioxide and Iron oxide Yellow) 750 mg tablets Opadry Pink (hydroxypropyl methylcellulose, polyethylene glycol 4000, titanium dioxide Iron oxide Red and Iron oxide Yellow Meets USP Dissolution Test 3 str

Lisinopril and Hydrochlorothiazide LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Lisinopril and hydrochlorothiazide tablets, USP combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C 21 H 31 N 3 O 5 . 2H 2 O and its structural formula is: Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 and its structural formula is: Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.72, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets, USP are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg, containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide, lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg, containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide and lisinopril and hydrochlorothiazide tablets 20 mg/25 mg, containing 20 mg lisinopril and 25 mg hydrochlorothiazide. Inactive ingredients are dibasic calcium phosphate anhydrous, mannitol, corn starch, pre-gelatinized starch and magnesium stearate. Lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg and 20 mg/25 mg also contain both yellow iron oxide and red iron oxide. Structural formula 1 Structural formula 2

Lurasidone Hydrochloride LURASIDONE HYDROCHLORIDE
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C 28 H 36 N 4 O 2 S•HCl and its molecular weight is 529.14. The chemical structure is: Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, corn starch, hydroxy Propyl methyl cellulose, colloidal silicon dioxide, magnesium stearate, titanium dioxide, hypermellose, polyethelene glycol, polysorbate and additionally 80 mg tablets contains yellow iron oxide and FDC Blue #2/Indigotine Aluminum lake (12 to 14% dye). Lurasidone_Structure

Nabumetone NABUMETONE
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Nabumetone, USP is a naphthylalkanone designated chemically as 4-(6-methoxy-2- naphthalenyl)-2-butanone. Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2400 at pH 7.4. Each tablet, for oral administration contains either 500 mg or 750 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxy propyl methyl cellulose, sodium lauryl sulphate, colloidal silicon dioxide and magnesium stearate. The 500 mg tablets also contain opadry white (Titanium dioxide, Hypromellose 3cP, Hypromellose 6cP, Macrogol and Polysorbate 80) and the 750 mg tablets contain opadry beige (Hypromellose 6cP, titanium dioxide, iron oxide yellow, iron oxide red and Macrogol). Structure

Nadolol NADOLOL
20 mg
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Nadolol is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-( tert -butylamino)-3-[(5, 6, 7, 8-tetrahydro- cis -6, 7-dihydroxy-1-naphthyl)oxy]-2-propanol. Structural formula: Nadolol, USP is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol tablets, USP are available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients: lactose monohydrate, microcrystalline cellulose, povidone, D&C yellow No. 10, croscarmellose sodium, and magnesium stearate. image

Nicotine Transdermal System NICOTINE
EXELAN PHARMACEUTICALS, INC. FDA OTC

Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.

Nilotinib NILOTINIB
50 mg Capsule
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Nilotinib Capsules contains nilotinib d-tartrate, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib d-tartrate is a white to yellow powder with the molecular formula and weight, respectively, of C 32 H 28 F 3 N 7 O 7 and 679.61 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C 28 H 22 F 3 N 7 O and 529 g/mol, respectively). The solubility of nilotinib d-tartrate in aqueous solutions decreases with increasing pH. The pK a 1 of nilotinib d-tartrate was determined to be 4.0. The chemical name of nilotinib d-tartrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide D-Tartrate . Its structure is shown below: Nilotinib Capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib, anhydrous (equivalent to 64.172 mg, 192.517 mg, and 256.689 mg nilotinib d-tartrate, respectively). The inactive ingredients of Nilotinib Capsules are colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium aluminometasilicate, magnesium stearate, and polysorbate 80. The inactive ingredients in the empty capsules contain gelatin, iron oxide (black), iron oxide (red), iron oxide (yellow), and titanium dioxide. The black ink contains iron oxide (black), potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. structure

OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Oseltamivir phosphate, USP an influenza neuraminidase inhibitor (NAI), is available as a powder for oral suspension, which when constituted with water as directed contains 6 mg per mL oseltamivir base. In addition to the active ingredient, the powder for oral suspension contains colloidal silicon dioxide, monosodium citrate, saccharin sodium, sodium benzoate, sorbitol, titanium dioxide, tutti-frutti flavoring, and xanthan gum. Oseltamivir phosphate, USP is a white to off-white powder with the chemical name (3R,4R,5S)-4-acetylamino-5-amino-3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1). The chemical formula is C 16 H 28 N 2 O 4 (free base). The molecular weight is 312.4 for oseltamivir free base and 410.4 for oseltamivir phosphate salt. The structural formula is as follows: Oseltamivir phosphate_Structure

OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Oseltamivir phosphate, USP, an influenza neuraminidase inhibitor (NAI), is available as: Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate, USP. In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone K30, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains Croscarmellose Sodium, Pregelatinized Starch, Talc, and Sodium Stearyl Fumarate. The 45 mg capsule shell contains Croscarmellose Sodium, Pregelatinized Starch, Talc, and Sodium Stearyl Fumarate. The 75 mg capsule shell contains Croscarmellose Sodium, Pregelatinized Starch, Talc, and Sodium Stearyl Fumarate. Oseltamivir phosphate, USP is a white to off-white powder with the chemical name (3R,4R,5S)-4-acetylamino-5-amino3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1). The chemical formula is C16H28N2O4 (free base). The molecular weight is 312.4 for oseltamivir free base and 410.4 for oseltamivir phosphate salt. The structural formula is as follows: Structure

Phytonadione PHYTONADIONE
5 mg Tablet
EXELAN PHARMACEUTICALS, INC. FDA Rx Only

Phytonadione is a vitamin K replacement, which is a clear, yellow to amber, viscous, and nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.7. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C31H46O2 and its structural formula is: Phytonadione tablets, USP for oral administration contain 5 mg of phytonadione, USP and are pale yellow colored, round tablets, scored on one side. Inactive ingredients are acacia, anhydrous dibasic calcium phosphate, lactose monohydrate, magnesium stearate, pregelatinized starch, silicon dioxide and talc. Phytonadione_Structure.jpg

Pirfenidone PIRFENIDONE
267 mg Tablet
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Pirfenidone belongs to the chemical class of pyridone. Pirfenidone is available as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone has a molecular formula of C 12 H 11 NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white or pale yellow, crystalline powder. It is sparingly soluble in water, freely soluble in ethanol (96%), very slightly soluble in heptane. The melting point is approximately 109°C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, magnesium stearate, silicified microcrystalline cellulose, hypromellose, titanium dioxide, macrogol (polyethylene glycol). Additionally 267 mg tablets contain iron oxide yellow, iron oxide red and 801 mg tablets contain iron oxide yellow, iron oxide red, iron oxide black. pirfenidone

PIRFENIDONE PIRFENIDONE
267 mg Capsule
EXELAN PHARMACEUTICALS INC. FDA Rx Only

Pirfenidone belongs to the chemical class of pyridone. Pirfenidone capsules is available as white opaque hard gelatin capsules containing 267 mg of pirfenidone for oral administration. Pirfenidone has a molecular formula of C 12 H 11 NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white or pale yellow, crystalline powder. It is sparingly soluble in water, freely soluble in ethanol (96%), very slightly soluble in heptane. The melting point is approximately 109°C. Pirfenidone capsules contain pirfenidone and the following inactive ingredients: silicified microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. In addition, the capsule shell contains gelatin, titanium dioxide and sodium lauryl sulfate. The capsule brown printing ink includes shellac glaze, n-butyl alcohol, isopropyl alcohol, ferroso ferric oxide/black iron oxide, iron oxide red, propylene glycol, iron oxide yellow and ammonium hydroxide. Chemical Structure

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