camber pharmaceuticals, inc. - Medication Listings

The chemical name of eslicarbazepine acetate is (S)-10-Acetoxy-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide. Eslicarbazepine acetate is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C 17 H 16 N 2 O 3 and its molecular weight is 296.33. The chemical structure is: Eslicarbazepine acetate is a white to off-white color powder, slightly hygroscopic. It is soluble in methanol, acetonitrile and in dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, glyceryl mono stearate, povidone and sodium stearyl fumarate. eslicarbazipine-structure

Eszopiclone is a hypnotic agent/nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-4-Methyl-1-piperazinecarboxylic acid 6-(5-chloro-2-pyridinyl)-6,7-dihydro-7-oxo-5 H pyrrolo[3,4- b ]pyrazin-5-(S)-yl ester. Its molecular weight is 388.81, and its molecular formula is C 17 H 17 ClN 6 O 3 . Eszopiclone has a single chiral center with an ( S )-configuration. It has the following chemical structure: Eszopiclone USP is a white to slight yellowish powder. Eszopiclone USP is soluble in methylene chloride and dilute hydrochloric acid; practically insoluble in water and in alcohol. Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets, USP contain 1 mg, 2 mg, or 3 mg eszopiclone USP and the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, hypromellose lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2/indigo carmine aluminium lake. eszopiclonestructure

Ezetimibe is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe is (3R, 4S)-1-(ρ-Fluorophenyl)-3-[(3 S )-3-(ρ-fluorophenyl)-3-hydroxypropyl]-4-(ρ-hydroxyphenyl)-2-azetidinone. The molecular formula is C 24 H 21 F 2 NO 3 . Its relative molecular mass is 409.43 and its structural formula is: Ezetimibe USP is a white to off-white, crystalline powder, hygroscopic that is soluble in absolute alcohol (99.5%), acetonitrile and practically insoluble in water and in hexane. Ezetimibe is available as a tablet for oral administration containing 10 mg of ezetimibe USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. ezetimibetabletstructure

The active ingredient in famciclovir tablets is famciclovir, USP, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir, USP is known as 2-[2-(2-amino-9 H -purin-9-yl) ethyl]-1,3-propanediol diacetate. Its molecular formula is C 14 H 19 N 5 O 4 ; its molecular weight is 321.3. It is a synthetic acyclic guanine derivative and has the following structure Famciclovir, USP is a white to pale yellow solid. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir, USP is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir, USP is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P=1.09 and octanol/phosphate buffer (pH 7.4) P=2.08. Famciclovir tablets contain 125 mg, 250 mg or 500 mg of famciclovir, USP, together with the following inactive ingredients: hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and sodium starch glycolate. The tablets are coated with opadry white which contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. Figure1

The active ingredient in famotidine for oral suspension USP is a histamine-2 (H 2) receptor antagonist. Famotidine is Propanimidamide, N’(aminosulfonyl)-3[[[2[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]-. The empirical formula of famotidine is C 8 H 15 N 7 O 2 S 3 and its molecular weight is 337.45. Its structural formula is: Each 5 mL of famotidine for oral suspension, USP when prepared as directed contains 40 mg of famotidine USP and the following inactive ingredients: citric acid, flavors (banana, cherry and peppermint),and powder cellulose, sucrose and xanthan gum. Added as preservatives are sodium benzoate 0.38%, sodium methylparaben 0.38% and sodium propylparaben 0.08%. Famotidine USP is a white to pale yellow crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water. famotidine-structure

The active ingredient in famotidine tablets, USP is a histamine-2 (H 2 ) receptor antagonist. Famotidine is N' -(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl] thio]propanimidamide. The empirical formula of famotidine is C 8 H 15 N 7 O 2 S 3 and its molecular weight is 337.45. Its structural formula is: Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and film coating contains carnauba wax, hydroxypropyl cellulose, hypromellose, talc, titanium dioxide; and additionally 20 mg contains iron oxide red and iron oxide yellow. Famotidine, USP is a white to pale yellowish white crystalline powder that is freely soluble in dimethyl formamide, glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in acetone, in alcohol, in chloroform, in ether and ethyl acetate. famotabstructure

Fenofibrate tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate USP. The chemical name for fenofibrate USP is Isopropyl-2-[p-(p-chlorobenzoyl) phenoxy]-2-methylpropanoate with the following structural formula: The molecular formula is C 20 H 21 ClO 4 and the molecular weight is 360.83; fenofibrate USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients Each tablet contains croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate and sucrose. The 48 mg tablets are coated with Opadry Yellow, which contains D&C Yellow # 10 aluminum lake, FD&C Blue # 2 / indigo caramine aluminum lake, FD&C Yellow # 6 / sunset yellow FCF aluminum lake, lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum. The 145 mg tablets are coated with Opadry White which contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthum gum. fenofibrate-structure-1

Fesoterodine fumarate tablet contains fesoterodine fumarate and is an extended-release tablet. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist. Chemically, fesoterodine fumarate is designated as Isobutyric acid 2-((R)-3-diisopropylammonium-1-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C 30 H 41 NO 7 and its molecular weight is 527.66. The structural formula is: Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water and soluble in methanol. Each Fesoterodine fumarate extended-release tablet contains either 4 mg or 8 mg of fesoterodine fumarate and the following inactive ingredients: citric acid monohydrate, colloidal silicon dioxide, FD&C blue#2/ indigo carmine aluminum lake, glyceryl behenate, hypromellose, lecithin, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. The botanical source for pregelatinized starch is maize starch. structure

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 USP 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. structure.jpg

Finasteride tablets USP, 1 mg contains finasteride as the active ingredient. 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 in to 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 1 mg of finasteride and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, docusate sodium, magnesium stearate and opadry brown (hypromellose, iron oxide red, talc, titanium dioxide, yellow iron oxide). structure6

Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod is 2-Amino-2-[2-(4-octyl-phenyl)ethyl]-1, 3-propanediol Hydrochloride. Its structure is shown below: Fingolimod hydrochloride USP is an off-white to white powder that is freely soluble in water and in alcohol. It has a molecular weight of 343.94 g/mol. Fingolimod is provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride USP, equivalent to 0.5 mg of fingolimod. Each fingolimod 0.5 mg capsule contains the following inactive ingredients: black iron oxide, FD&C blue # 2 aluminum lake, gelatin, iron oxide yellow, magnesium stearate, potassium hydroxide, powdered cellulose, propylene glycol, shellac, sodium lauryl sulfate and titanium dioxide. fingolimodstructure

Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 2-[4-[3-[2-(trifluoromethyl)-10H-phenothiazin-10-yl] propyl]piperazin-1-yl-ethanol dihydrochloride. The structural formula is represented below: Molecular Formula: C 22 H 26 F 3 N 3 OS•2HCl MW: 510.44 Fluphenazine Hydrochloride Tablets, USP, for oral administration, contain 1 mg, 2.5 mg, 5 mg, or 10 mg fluphenazine hydrochloride, USP per tablet. Each tablet also contains croscarmellose sodium, D&C yellow # 10 (for 2.5 mg and 5 mg tablet), FD&C blue # 1 (for 5 mg tablet) and FD&C red # 40 (for 10 mg tablet), hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, titanium dioxide. Meets USP Dissolution Test 2. fluphenazinechemicalstructure

Fluvoxamine maleate extended-release capsule is an extended-release capsule for oral administration that contains fluvoxamine maleate, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. Fluvoxamine maleate is chemically designated as ( E )-5-Methoxy-4 (trifluoromethyl)valerophenone O -(2-aminoethyl)oxime, maleate (1:1) and has the empirical formula C 15 H 21 F 3 N 2 O 2 •C 4 H 4 O 4 . Its molecular weight is 434.41. The structural formula is: Fluvoxamine maleate USP is an white to off-white powder that is soluble in methanol, dimethyl formamide and dimethyl sulphoxide very slightly soluble in water. Fluvoxamine maleate extended-release capsules are available in 100 mg and 150 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate USP, each capsule contains the following inactive ingredients: ethyl cellulose, FD&C Blue No. 1, ferric oxide yellow, gelatin, hydroxypropyl cellulose, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide, propylene glycol, ammonia solution and shellac. Fluvoxamine maleate extended-release capsules contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). fluvoxaminestructure

Fosaprepitant for injection is a sterile, lyophilized formulation containing fosaprepitant dimeglumine, a prodrug of aprepitant, a substance P/neurokinin-1 (NK 1 ) receptor antagonist, an antiemetic agent, chemically described as 1-Deoxy-1-(methylamino)-D-glucitol[3-[[(2 R ,3 S )-2-[(1 R )-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-2,5-dihydro-5-oxo-1 H -1,2,4-triazol-1-yl]phosphonate (2:1) (salt). Its empirical formula is C 23 H 22 F7N 4 O 6 P ⋅ 2(C 7 H 17 NO 5 ) and its structural formula is: Fosaprepitant dimeglumine is a white to light brown powder with a molecular weight of 1004.83. It is soluble in water and methanol. Each vial of fosaprepitant for injection for administration as an intravenous infusion contains 150 mg of fosaprepitant (equivalent to 245.3 mg of fosaprepitant dimeglumine) and the following inactive ingredients: edetate disodium (5.4 mg), lactose anhydrous (375 mg), polysorbate 80 (75 mg), sodium hydroxide and/or hydrochloric acid (for pH adjustment). structure.jpg

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: pregelatinized starch, microcrystalline cellulose, povidone, colloidal silicon dioxide, polysorbate, croscarmellose sodium, calcium stearate, hydroxypropyl cellulose, and talc. 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° – 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions. Struct

Glycopyrrolate is an anticholinergic drug available as an oral solution containing 1 mg glycopyrrolate per 5 mL. The chemical name for glycopyrrolate is Pyrrolidinium, 3-[(SR)-cyclopentylhydroxy phenylacetyl)oxy]-1,1-dimethyl-, [RS-]bromide;(RS)-[3-(SR)-Hydroxy-1,1-dimethylpyrrolidiniumbromide] α-cyclopentylmandelate. The chemical structure is: The empirical formula for glycopyrrolate is C 19 H 28 BrNO 3 and the molecular weight is 398.34. The inactive ingredients in glycopyrrolate oral solution are: citric acid monohydrate, glycerin, methyl paraben, non-crystallizing sorbitol solution (contains D-Sorbitol and Water), propylene glycol, propyl paraben, saccharin sodium, sorbitol, trisodium citrate dihydrate and ART cherry flavor. glycopyrolateosstucture.

HydrALAZINE hydrochloride, 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 o 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 anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, stearic acid and FD&C Yellow # 6. hydralazinechemicalstructure

Hydrocodone bitartrate and acetaminophen, USP is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula: Acetaminophen, 4' -hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP contains: Strength Hydrocodone Bitartrate Acetaminophen 2.5 mg/325 mg 2.5 mg 325 mg 7.5 mg/325 mg 7.5 mg 325 mg In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, colloidal silicon dioxide, crospovidone, pregelatinized starch, povidone, and stearic acid. Hydrocodone Bitartrate and Acetaminophen Tablets, USP complies to USP Dissolution Test 1. Structure-1 Structure-2

Hydrocodone bitartrate and acetaminophen, USP is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula: Acetaminophen, 4' -hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP contains: Strength Hydrocodone Bitartrate Acetaminophen 5 mg/325 mg 5 mg 325 mg 10 mg/325 mg 10 mg 325 mg In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, corn starch, colloidal silicon dioxide, crospovidone, pregelatinized starch, povidone, and stearic acid. Hydrocodone Bitartrate and Acetaminophen Tablets, USP complies to USP Dissolution Test 1. Hydrocodone - structural formula Acetaminophen - structural formula

Hydromorphone hydrochloride extended-release tablets are for oral use and contain hydromorphone hydrochloride, an opioid agonist. Hydromorphone hydrochloride USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride. Its empirical formula is C 17 H 19 NO 3 •HCl. The compound has the following structural formula: Hydromorphone hydrochloride extended-release tablets also contains the following inactive ingredients: Polyethylene Oxide, Povidone, butylated hydroxytoluene, Isopropyl Alcohol, Magnesium Stearate, Sodium Chloride, Hydroxypropyl Methyl Cellulose, Ferric Oxide Yellow, Acetone, Cellulose acetate, Polyethylene glycol, hypromellose and titanium dioxide The 8 mg, 12 mg and 16 mg also contains iron oxide yellow and polysorbate. The 32 mg also contains talc, black iron oxide and propylene glycol. Structure

Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine HCl, USP. Inactive ingredients include colloidal silicon dioxide, crospovidone, dibasic calcium phosphate anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, opadry white (hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide). structure.jpg

Ibuprofen and famotidine is supplied as a tablet for oral administration which combines the nonsteroidal anti-inflammatory drug, ibuprofen, and the histamine H 2 -receptor antagonist, famotidine. Ibuprofen is (±)-2-( p- isobutylphenyl)propionic acid. Its chemical formula is C 13 H 18 O 2 and molecular weight is 206.28. Ibuprofen is a white powder that is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. Its structural formula is: Famotidine is N'- (aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. Its chemical formula is C 8 H 15 N 7 O 2 S 3 and molecular weight is 337.43. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. Its structural formula is: Each ibuprofen and famotidine tablet contains ibuprofen (800 mg) and famotidine, USP (26.6 mg). The inactive ingredients in ibuprofen and famotidine tablet include: microcrystalline cellulose, pregelatinized starch, silicon dioxide, magnesium stearate, Hydroxy Propyl Methyl Cellulose, Glycerin, croscarmellose sodium, FD&C Blue#1, talc, povidone, FD&C Blue#2. Ibu-struct.jpg famotidine-struct.jpg

Icosapent ethyl capsules, a lipid-regulating agent, is supplied as either a 0.5 gram or a 1 gram liquid-filled clear, transparent soft gelatin capsules containing clear to light yellow colored solution for oral use. Each icosapent ethyl capsule contains either 0.5 grams of icosapent ethyl (in a 0.5 gram capsule) or 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C 22 H 34 O 2 and the molecular weight is 330.50. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure: Icosapent ethyl capsules also contain the following inactive ingredients: bloom gelatin, glycerin, alpha tocopherol, medium chain triglycerides, and lecithin. The capsules are imprinted with white imprinting ink containing titanium dioxide, propylene glycol, and hypromellose 2910. structure

Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.50 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 478 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl] amino]-phenyl] benzamide methanesulfonate and its structural formula is: Imatinib mesylate is a white to off-white colored powder. Its molecular formula is C 29 H 31 N 7 O•CH 3 SO 3 H and its molecular weight is 589.7 g/mol. Imatinib mesylate is freely soluble in water. Inactive Ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate and microcrystalline cellulose. Tablet coating: hypromellose, polyethylene glycol, talc and titanium dioxide. imatinibstructure

Indomethacin Suppositories USP is a nonsteroidal anti-inflammatory drug, available as a suppository containing 50 mg of indomethacin administered for rectal use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.79. Its molecular formula is C 19 H 16 ClNO 4 , and it has the following chemical structure. Indomethacin USP is a white to yellow crystalline powder. It is sparingly soluble in absolute alcohol, chloroform and ether and insoluble in water. It has a pKa of 4.7. The inactive ingredients in indomethacin suppositories include: Butylated hydroxy anisole, butylated hydroxy toluene, edetic acid, glycerin, polyethylene glycol 3350, polyethylene glycol 8000 and sodium chloride. Indomethacin suppositories, 50 mg each, are white to off-white, bullet shaped, rectal suppositories. FDA approved dissolution test specifications differ from USP. indomethacinstructure

Indomethacin extended-release capsules are nonsteroidal anti-inflammatory drugs, available as capsules containing 75 mg of indomethacin, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1 H -indole-3-acetic acid. The molecular weight is 357.80. Its molecular formula is C 19 H 16 ClNO 4 , and it has the following chemical structure. Indomethacin, USP is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. Each extended-release capsule, for oral administration contains 75 mg of indomethacin and the following inactive ingredients: sugar spheres, povidone, mannitol, isopropyl alcohol, talc. The hard gelatin shell consists of gelatin, iron oxide yellow, titanium dioxide, sodium lauryl sulfate. The imprinting ink contains the following: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide E172 dye and potassium hydroxide. This product meets USP Drug Release Test 2 Specifications. structure

Indomethacin capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 25 mg or 50 mg of indomethacin USP, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1 H -indole-3-acetic acid. The molecular weight is 357.79. Its molecular formula is C 19 H 16 ClNO 4 , and it has the following chemical structure. Indomethacin USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol, in chloroform and in ether. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin capsules USP, 25 mg or 50 mg include: lactose monohydrate, sodium lauryl sulfate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate. The hard gelatin shell consists of gelatin, titanium dioxide, FD & C Blue 1, D & C Yellow 10. The capsules are printed with black ink containing black iron oxide E172 dye. indomethacinstructure

Irbesartan is an angiotensin II receptor (AT1 subtype) antagonist. Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5­ ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C 25 H 28 N 6 O, and the structural formula: Irbesartan USP is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan USP is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Irbesartan tablets, USP are available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of irbesartan. Inactive ingredients include: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone, colloidal silicon dioxide, and magnesium stearate. Irbesartanstructure

Irbesartan is an angiotensin II receptor (AT 1 subtype) antagonist. Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3 -[p-(o-1H -tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4] non-1-en-4-one. Its empirical formula is C 25 H 28 N 6 O, and the structural formula: Irbesartan USP is a white to off-white crystalline powder with a molecular weight of 428.53. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in ethanol and methylene chloride and practically insoluble in water. Irbesartan is available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of Irbesartan USP. Inactive ingredients include: calcium stearate, carboxy methyl cellulose calcium, colloidal silicon dioxide, microcrystalline cellulose and povidone. image1

Itraconazole, an azole antifungal agent. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature: (±)-1-sec-Butyl-4-[p-[4-[p-[[2R * ,4S * )-2-(2,4-dichloro phenyl)-2-(1H-1, 2, 4-triazol-1 ylmethyl)-1,3- dioxolan-4 yl]methoxy]phenyl]-1-piperazinyl]phenyl]- Δ 2 -1, 2, 4-triazolin-5- one or 4-[4-[4-[4-[[Cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4- triazol-1-ylmethyl)-1,3-dioxolan-4 yl]methoxy] phenyl]piperazin-1-yl] phenyl]-2-[(1RS)-1-methyl propyl]-2,4-dihydro-3H-1,2,4-triazol-3-one Itraconazole has a molecular formula of C 35 H 38 Cl 2 N 8 O 4 and a molecular weight of 705.63. It is a white or almost white powder. It is freely soluble in methylene chloride, sparingly soluble in tetrahydrofuran, very slightly soluble in alcohol, practically insoluble in water. It has a pKa of 3.70 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/ aq. Buffer of pH: 8.1) partition coefficient of 5.66 at pH 8.1. Itraconazole oral solution contains 10 mg of itraconazole USP per mL, solubilized by hydroxypropyl-β-cyclodextrin (400 mg/mL) as a molecular inclusion complex. Itraconazole oral solution is clear, colorless to yellowish brown liquid with a target pH of 2. Other ingredients are ascorbic acid, hydrochloric acid, propylene glycol, purified water, non crystallizing sorbitol solution, saccharin sodium, sodium hydroxide, ART Cherry flavor. structute

Ivabradine tablets contains ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the I f current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. The chemical name for ivabradine hydrochloride is 3-(3-{[((7 S )-3,4-Dimethoxybicyclo [4.2.0] octa-1,3,5-trien-7-yl)methyl] methyl amino} propyl) -1,3,4,5-tetrahydro-7,8-dimethoxy-2 H -3-benzazepin-2-one, hydrochloride. The molecular formula is C 27 H 36 N 2 O 5 . HCl, and the molecular weight (free base + HCl) is 505.1 (468.6 + 36.5). The chemical structure of ivabradine is shown in Figure 1. Figure 1. Chemical Structure of Ivabradine Ivabradine tablets are supplied in 5 mg and 7.5 mg tablets for oral administration. The tablets contain 5 mg and 7.5 mg of ivabradine, as the active ingredient, equivalent to 5.39 mg and 8.09 mg of ivabradine hydrochloride, respectively. Inactive Ingredients Colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate and maltodextrin. The film coating contains glycerin, hypromellose, magnesium stearate, polyethylene glycol, titanium dioxide. In addition, 7.5 mg contains black iron oxide, iron oxide yellow and iron oxide red. ivabradinetabstructure

Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid compound with 2-Amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and the structural formula is presented in Figure 1. FIGURE 1 C 15 H 13 NO 3 .C 4 H 11 NO 3 Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. Freely soluble in water and in methanol; slightly soluble in alcohol, in dehydrated alcohol, and in tetrahydrofuran: practically insoluble in acetone, in dichloromethane, in toluene, in ethyl acetate, in dioxane, in hexane, in butyl alcohol, and in acetonitrile. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, 1 mg, 1 mg and 2 mg, respectively of citric acid anhydrous and 6.68 mg, 4.35 mg, and 8.70 mg, respectively of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow color solution. ketorolactromethaminefigure1

Ketorolac tromethamine tablets, USP are a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine, USP is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the chemical structure is: Ketorolac tromethamine, USP is a racemic mixture of [-]S and [+]R ketorolac tromethamine, USP. Ketorolac tromethamine, USP may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine, USP has a pKa of 7.8 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.4. Its molecular formula is C 19 H 24 N 2 O 6 . Ketorolac tromethamine tablets, USP are available as round, white to off-white, film-coated, bevel edged biconvex tablets. Each tablet contains 10 mg ketorolac tromethamine, USP, the active ingredient, with added hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and lactose monohydrate. The white film-coating contains hypromellose, polyethylene glycol and titanium dioxide. structure

The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13 H 18 N 2 O 3 and its molecular weight is 250.30. The chemical structure is: Lacosamide USP is a white to light yellow powder. It is freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile practically insoluble in heptane. 11.2 Lacosamide Injection, USP Lacosamide injection, USP is a clear, colorless, sterile solution containing 10 mg lacosamide per mL for intravenous infusion. One 20-mL vial contains 200 mg of lacosamide drug substance. The inactive ingredients are sodium chloride (7.60 mg/mL) and water for injection. Hydrochloric acid is used for pH adjustment. Lacosamide injection, USP has a pH of 3.8 to 5.0. lacosamide-inj-structure

The chemical name of lacosamide is (2R)-2-(Acetylamino)-3-methoxy-N-(phenylmethyl) propanamide. Lacosamide is a functionalized amino acid. Its molecular formula is C 13 H 18 N 2 O 3 and its molecular weight is 250.29. The chemical structure is: Lacosamide, USP is a white to light yellow powder. It is freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile practically insoluble in heptane. lacosamideosstructure 11.3 Lacosamide Oral Solution Lacosamide oral solution, USP contains 10 mg of lacosamide per mL. The inactive ingredients are acesulfame potassium, anhydrous citric acid, aspartame, carboxymethylcellulose sodium, glycerin, methylparaben sodium, polyethylene glycol, propylene glycol, prosweet, purified water, sodium chloride, sorbitol and strawberry flavor.

The chemical name of lacosamide, the single (R)- enantiomer, is (R)- N-Benzyl-2-acetamido-3-methoxypropionamide. Lacosamide is a functionalized amino acid. Its molecular formula is C 13 H 18 N 2 O 3 and its molecular weight is 250.29. The chemical structure is: Lacosamide, USP is a white to light yellow powder. It is freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile practically insoluble in heptane. lacosamide-str 11.1 Lacosamide Tablets Lacosamide tablets, USP for oral administration contain lacosamide and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lecithin, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. In addition to this the 50 mg tablets contain FD&C Blue #2/indigo carmine aluminum lake, iron oxide black and iron oxide red. 100 mg tablets contain iron oxide yellow. 150 mg tablets contain iron oxide black, iron oxide red and iron oxide yellow. 200 mg tablets contain FD&C Blue #2/indigo carmine aluminum lake.

Lamivudine tablet, USP (HBV) is a synthetic nucleoside analogue with activity against HBV. The chemical name of lamivudine, USP 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 USP is a white to an off white solid and soluble in water. Lamivudine Tablets, USP (HBV) are for oral administration. Each tablet contains 100 mg of lamivudine USP and the inactive ingredients magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The tablets are coated with opadry white containing hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. lamivudinestructure

Lamivudine tablet (HBV) is a synthetic nucleoside analogue with activity against HBV. The chemical name of lamivudine, USP 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 USP is a white to an off white solid and soluble in water. Lamivudine Tablets (HBV) are for oral administration. Each tablet contains 100 mg of lamivudine, USP and the inactive ingredients crospovidone, isomalt, isopropyl alcohol, magnesium stearate and methylene chloride. The tablets are coated with Opadry Pink containing hypromellose, iron oxide red, polyethylene glycol, polysorbate 80, titanium dioxide and yellow iron oxide. structure.jpg

Lamivudine (also known as 3TC), a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine USP is 2(1H) - Pyrimidinone, 4-amino-1- [2- (hydroxymethyl)-1, 3-oxathio-lan-5-yl], (2R-cis)-. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26. It has the following structural formula: Lamivudine USP is a white to an off white solid and soluble in water. Lamivudine tablets are for oral administration. Each film-coated tablet contains 150 mg or 300 mg of lamivudine USP and the following inactive ingredients: crospovidone, isomalt, isopropyl alcohol, magnesium stearate and methylene chloride. The tablets are coated with opadry white containing hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. lamivudinestruc

Lamivudine and Zidovudine tablets, USP are combination tablets containing lamivudine and zidovudine. Lamivudine (EPIVIR) and zidovudine (RETROVIR, 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 microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate and opadry white (hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide). Lamivudine The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidine-2-one. Lamivudine is the (-) enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2',3'-dideoxy, 3'-thiacytidine. It has a molecular formula of C 8 H 11 N 3 0 3 S and a molecular weight of 229.26. It has the following structural formula: Lamivudine USP is a white to off-white crystalline solid with a solubility of approximately 70 mg/mL in water at 20°C. Zidovudine The chemical name of zidovudine is 3'-azido-3'-deoxythymidine. 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 USP is a white to beige, odorless, crystalline solid with a solubility of 20.1 mg/mL in water at 25°C. Meets USP Dissolution Test 2. lamivudinestructure zedovudinechemicalstructure

Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as -triazine, its molecular formula is C 9 H 7 N 5 Cl 2 , and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pK a of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is: Lamotrigine Extended-Release Tablets, USP are supplied for oral administration as 25-mg (yellow), 50-mg (green), 100-mg (orange), 200-mg (blue), 250-mg (purple), and 300-mg (gray) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl arcylate copolymer dispersion, mono- and di-glycerides, polysorbate 80, silicon dioxide(25- and 50- mg tablets only), sodium hydroxide, sodium lauryl sulfate, titanium dioxide, triethyl citrate, iron oxide black(50- and 300- mg tablets only), iron oxide red(100- and 250- mg tablets only), iron oxide yellow(25-, 50-, 100- mg tablets only), FD&C Blue No. 2 Aluminum Lake(200- and 250- mg tablets only). Tablets are printed with edible black ink (black ink is composed of ferrosoferric oxide, propylene glycol and shellac). Lamotrigine Extended-Release Tablets, USP contain a modified-release formulation as the core. The tablets are coated with a clear enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. FDA approved dissolution test specifications differ from USP. Chemical Structure

The active ingredient in lansoprazole delayed-release capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]-methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C 16 H 14 F 3 N 3 O 2 S with a molecular weight of 369.36. Lansoprazole has the following structure: Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. The rate of degradation of the compound in aqueous solution increases with decreasing pH. Lansoprazole is supplied in delayed-release capsules for oral administration. Lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 mg and 30 mg of lansoprazole, USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer dispersion, polysorbate 80, sucrose, sugar spheres (contains sucrose and starch (maize)), talc, titanium dioxide and triethyl citrate. The hard gelatin capsule shell consists of gelatin, FD&C Blue No. 1, D&C Red No. 28, FD&C Red No. 40 and titanium dioxide. In addition 15 mg capsule contains FD&C Green No. 3. The imprinting ink contains polysorbate 80, propylene glycol, shellac and titanium dioxide. Lansoprazolestructure

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 the gram molecular weight is 259.27. Lenalidomide is an off-white to pale-yellow powder. It is slightly soluble in dimethyl formamide. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/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, 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: anhydrous lactose, croscarmellose sodium, magnesium stearate and microcrystalline cellulose. The capsule shell contains gelatin, titanium dioxide, in addition 2.5 mg, 15 mg, and 20 mg contains iron oxide red, 10 mg contains FD&C Yellow 6, 20 mg contains iron oxide yellow and iron oxide black. The capsules are imprinted with ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. lenalidomidestructure

Levetiracetam is an antiepileptic drug available as a clear, colorless, grape-flavored liquid (100 mg/mL) 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, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1,040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.) Levetiracetam oral solution, USP contains 100 mg of levetiracetam, USP per mL. Inactive ingredients: acesulfame potassium, artificial grape flavor, citric acid monohydrate, glycerin, glycyrrhizate ammonium, maltitol solution, methyl paraben, propyl paraben, purified water and sodium citrate dihydrate. leve-structure

Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-a-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 USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.) Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below: 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc) 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc) 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc) 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc) USP Dissolution test is 4. levetiracetamtabletsstructure

Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets, is an orally active H 1 -receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C 21 H 25 ClN 2 O 3 •2HCl. The molecular weight is 461.82 and the chemical structure is shown below: Levocetirizine dihydrochloride USP is white to almost white powder and is freely soluble in water and in methanol. Levocetirizine dihydrochloride tablets, USP 5 mg are white film coated, scored, round, biconvex tablets for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose and opadry white YS-1-7003 which contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. levocitirizinestructure

Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride oral solution is an orally active H 1 -receptor antagonist. The chemical name is 2-[2-[4[(R)-(4-chlorophenyl) –phenyl-methyl] piperazine-1-yl]ethoxy] acetic acid. Dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C 21 H 27 Cl 3 N 2 O 3 . The molecular weight is 461.8 and the chemical structure is shown below: Levocetirizine dihydrochloride USP is a white to almost white powder and is freely soluble in water and in methanol Levocetirizine dihydrochloride 0.5 mg/mL oral solution is formulated as an immediate release, clear, colorless liquid. Inactive ingredients are: artificial grape flavor, glacial acetic acid, glycerin, maltitol solution, methyl paraben, propyl paraben, purified water, saccharin sodium and sodium acetate trihydrate. chemicalstructure

Levofloxacin tablets, USP are synthetic antibacterial agents for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin, USP The molecular formula is C 18 H 20 FN 3 O 4 • 1⁄2 H 2 O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish-white to yellow-white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin, USP is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin, USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al +3 >Cu +2 >Zn +2 >Mg +2 >Ca +2 . Levofloxacin Tablets, USP are available as film-coated tablets and contain the following inactive ingredients: • 250 mg: croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. • 500 mg: croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. • 750 mg: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. Levofloxacin tablets, USP meets USP Dissolution Test 2. levofloxacinfigure1

21 white active tablets each containing 0.1 mg of levonorgestrel USP, (17α)-(-)-13-ethyl-17-hydroxy-18,19, dinorpregna-4-en-20-yn-3-one, and 0.02 mg of ethinyl estradiol USP, 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17β-diol. The inactive ingredients present are cellulose microcrystalline, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and povidone. 7 orange inert tablets, each containing cellulose microcrystalline, colloidal silicon dioxide, FD&C Red#40, FD&C Yellow#6, iron oxide yellow, lactose monohydrate, magnesium stearate. Levonorgestrel C 21 H 28 O 2 M.W. 312.5 Ethinyl Estradiol C 20 H 24 O 2 M.W. 296.41 Levonorgestrelstructure Ethinylestradiolstructure

Lidocaine hydrochloride injection, USP contains lidocaine hydrochloride, USP, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for lidocaine hydrochloride is by injection, for infiltration, nerve block, epidural and caudal use. Lidocaine hydrochloride, USP is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular weight of 270.8. g/mol. Lidocaine hydrochloride molecular formula is C 14 H 22 N 2 O.HCl, and has the following structural formula: Lidocaine hydrochloride injection, USP is a sterile, nonpyrogenic, isotonic solution containing sodium chloride and preservative-free solution. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and hydrochloric acid. Ingredients Strength 1% 2% Amount (Per mL) Amount (Per mL) Lidocaine Hydrochloride (Anhydrous) 10 mg £ 20 mg μ Sodium Chloride 7 mg § 6 mg Sodium Hydroxide Added for pH Adjustment to approximately 6.5 (5.0 to 7.0) Hydrochloric Acid £ Quantity is equivalent to 7 mg/mL lidocaine hydrochloride, USP (monohydrate). μ Quantity is equivalent to 21.4 mg/mL lidocaine hydrochloride, USP (monohydrate). lidocainehydrochloridestructure