bluepoint laboratories - Medication Listings

Browse 163 medications manufactured by bluepoint laboratories. Open a product record to review dosage forms, strengths, packaging, and related navigation.

Lisinopril LISINOPRIL
#2 2.5 mg Tablet
BLUEPOINT LABORATORIES 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 C 21 H 31 N 3 O 5 2H 2 O and its structural formula is: Lisinopril is a 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 - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch and starch (corn). 5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, red ferric oxide, pre-gelatinized starch and starch (corn). 40 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, yellow ferric oxide, pre-gelatinized starch and starch (corn). Lisinopril

Metoprolol Succinate METOPROLOL SUCCINATE
#6 25 mg Extended-release
BLUEPOINT LABORATORIES FDA Rx Only

Metoprolol succinate is a beta 1 -selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is: Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl acetate, acetone, diethylether and heptane. Inactive ingredients: sugar spheres, povidone, ethyl cellulose, polyethylene glycol, hydroxypropyl cellulose, triethyl citrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, polydextrose, hypromellose, and triacetin*. *may be replaced by talc. Meets USP Dissolution Test 5. image-01

Metoprolol succinate METOPROLOL SUCCINATE
#6 100 mg Extended-release
BLUEPOINT LABORATORIES FDA Rx Only

Metoprolol succinate, is a beta 1 -selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Metoprolol succinate extended-release tablets USP, have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 95 mg and 190 mg of metoprolol succinate equivalent to 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is: Metoprolol succinate USP, is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide.. structure

METOPROLOL SUCCINATE METOPROLOL SUCCINATE
#6 50 mg Extended-release
BLUEPOINT LABORATORIES FDA Rx Only

Metoprolol succinate is a beta 1 -selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit systemcontaining metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 47.5, 95 and 190 mg of metoprolol succinate equivalent to 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is: Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, crosspovidone, ethyl cellulose, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, methylene chloride, microcrystalline cellulose, microcrystalline cellulose sphere, polyethylene glycol, sodium stearyl fumarate and talc. The tablets are film-coated with coating material Opadry white 04F58804 containing hypromellose, polyethylene glycol and titanium dioxide. image

Omeprazole OMEPRAZOLE
#7 20 mg
BLUEPOINT LABORATORIES FDA OTC

Use(s) treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Montelukast MONTELUKAST
#10 10 mg Tablet
BLUEPOINT LABORATORIES FDA Rx Only

Montelukast sodium, USP the active ingredient in montelukast sodium tablets, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium, USP is described chemically as [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl] phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl] propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35 H 35 ClNNaO 3 S, and its molecular weight is 608.18. The structural formula is: Montelukast sodium, USP is a hygroscopic, optically active, white to off-white powder. Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. Each 10-mg film-coated montelukast tablet contains 10.4 mg montelukast sodium, USP which is equivalent to 10 mg of montelukast, and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose, disodium edetate and magnesium stearate. The film coating consists of: hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, red ferric oxide and yellow ferric oxide. montelukast-structural

Gabapentin GABAPENTIN
#11 600 mg Tablet
BLUEPOINT LABORATORIES FDA Rx Only

The active ingredient in Gabapentin Tablets, USP is gabapentin, USP, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin, USP is C 9 H 17 NO 2 and the molecular weight is 171.24 g/mol. The structural formula of gabapentin, USP 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, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: corn starch, copovidone, poloxamer 407, magnesium stearate, opadry white, polyethylene glycol and talc. Additionally, the coating material opadry white contains hypromellose, macrogol, polysorbate 80 and titanium dioxide. Molecula Formula Gabapentin

Carvedilol CARVEDILOL
#18 3.125 mg Tablet
BLUEPOINT LABORATORIES FDA Rx Only

Carvedilol is a nonselective β-adrenergic blocking agent with α 1 -blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure: Carvedilol, USP is a white to almost white crystalline powder with a molecular weight of 406.5 and a molecular formula of C 24 H 26 N 2 O 4 . It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Each carvedilol tablet, USP intended for oral administration contains 3.125 mg or 6.25 mg or 12.5 mg or 25 mg of carvedilol. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc and titanium dioxide. The product meets USP Dissolution Test 3. structured formula for carvedilol

Fluoxetine FLUOXETINE
#22 10 mg Capsule
BLUEPOINT LABORATORIES FDA Rx Only

Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p -tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17 H 18 F 3 NO•HCl. Its molecular weight is 345.79. The structural formula is: Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Chemical Structure

Fluoxetine FLUOXETINE HYDROCHLORIDE
BLUEPOINT LABORATORIES FDA Rx Only

Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p -tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17 H 18 F 3 NO•HCl. Its molecular weight is 345.79. The structural formula is: Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Chemical Structure

Triamterene and Hydrochlorothiazide TRIAMTERENE AND HYDROCHLOROTHIAZIDE
BLUEPOINT LABORATORIES FDA Rx Only

Rx Only DESCRIPTION Triamterene and hydrochlorothiazide combines triamterene, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and Hydrochlorothiazide 37.5 mg/25 mg Tablet, USP contains 37.5 mg of Triamterene, USP and 25 mg of Hydrochlorothiazide, USP. Each Triamterene and Hydrochlorothiazide 75 mg/50 mg Tablet, USP contains 75 mg of Triamterene, USP and 50 mg of Hydrochlorothiazide, USP. Triamterene and hydrochlorothiazide tablets for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. In addition, the 37.5 mg/25 mg tablets contain D&C Yellow No.10 Aluminum Lake and FD&C Blue No.1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene is very slightly soluble in acetic acid, alcohol and dilute mineral acids. The following is the structural formula: Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H -1,2,4, benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution, n-butylamine and dimethylformamide. It is sparingly soluble in methanol and insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.73. The following is the structural formula: structure-triamterene structure-hydrochlorothiazide

Triamterene and Hydrochlorothiazide TRIAMTERENE AND HYDROCHLOROTHIAZIDE
BLUEPOINT LABORATORIES FDA Rx Only

Triamterene and Hydrochlorothiazide Tablets, USP, combines triamterene USP, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide, USP. Triamterene and hydrochlorothiazide tablets, USP are available in two strengths. Each triamterene and hydrochlorothiazide tablet,USP 75 mg/50 mg, contains triamterene, USP, 75 mg and hydrochlorothiazide, USP, 50 mg. Each triamterene and hydrochlorothaizide tablet, USP 37.5 mg/25 mg, contains triamterene, USP, 37.5 mg and hydrochlorothiazide, USP, 25 mg. Both strengths of triamterene and hydrochlorothiazide tablets, USP for oral administration contain the following inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol 8000, and povidone. Triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg also contain FD&C Blue No.2 Aluminum Lake. Triamterene, USP is 2, 4, 7-triamino-6-phenylpteridine. Triamterene, USP is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene, USP is very slightly soluble in acetic acid, alcohol and dilute mineral acids. Its molecular weight is 253.27. Its structural formula is: Hydrochlorothiazide, USP is 6-chloro-3, 4-dihydro-2 H -1, 2, 4-benzothiadiazine-7-sulfonamide 1, 1-dioxide. Hydrochlorothiazide, USP is slightly soluble in water and freely soluble in sodium hydroxide solution, n-butylamine and dimethylformamide. It is sparingly soluble in methanol and insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.73. Its structural formula is: Triamterene Chemical Structure Hydrochlorothiazide Chemical Structure

CHILDRENS IBUPROFEN IBUPROFEN
BLUEPOINT LABORATORIES FDA OTC

Uses temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever

Sildenafil SILDENAFIL
#28 20 mg Tablet
BLUEPOINT LABORATORIES FDA Rx Only

Sildenafil Tablets, USP phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA ® for erectile dysfunction. Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H -pyrazolo [4,3- d ] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil Tablets USP, 20 mg: Sildenafil tablets are formulated as white to off-white, film-coated round tablets for oral administration. Each tablet contains sildenafil citrate equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate, USP each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate dihydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide and triacetin. Molecule

Acetaminophen ACETAMINOPHEN
#34 650 mg
BLUEPOINT LABORATORIES FDA OTC

Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever

Duloxetine DULOXETINE
#35 20 mg Delayed-release
BLUEPOINT LABORATORIES FDA Rx Only

Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S )- N -methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C 18 H 19 NOS•HCl, which corresponds to a molecular weight of 333.88. The structural formula is: Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20 mg, 30 mg, 40 mg or 60 mg of duloxetine hydrochloride USP (equivalent to 22.4 mg, 33.7 mg, 44.9 mg or 67.3 mg of duloxetine, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending. structure

Duloxetine Delayed-Release DULOXETINE HYDROCHLORIDE
BLUEPOINT LABORATORIES FDA Rx Only

Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S )- N -methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C 18 H 19 NOS∙HCl, which corresponds to a molecular weight of 333.88. The structural formula is: Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 40 mg of duloxetine (equivalent to 44.9 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 40 mg hard gelatin capsule colorants are FD&C Blue No. 2, red iron oxide, and yellow iron oxide. Chemical Structure

Fexofenadine hydrochloride FEXOFENADINE HYDROCHLORIDE
BLUEPOINT LABORATORIES FDA OTC

Use(s) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat

Escitalopram ESCITALOPRAM
#43 5 mg Tablet
BLUEPOINT LABORATORIES FDA Rx Only

Escitalopram tablets contains escitalopram 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(dimethylamino) propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula: The molecular formula is C 20 H 21 FN 2O • C 2 H 2 O 4 and the molecular weight is 414.40. Escitalopram oxalate, USP 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, for oral use, are film-coated, round tablets containing 6.40 mg, 12.80 mg, 25.60 mg escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively, of escitalopram base. The 10 mg and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, and a film coating agent. The film coating agent, Opadry II White Y-22-7719, contains the following ingredients: hypromellose, polydextrose, polyethylene glycol, triacetin, and titanium dioxide. Meets USP Dissolution Test 2. Structural Formula

Abiraterone ABIRATERONE ACETATE
BLUEPOINT LABORATORIES FDA Rx Only

Abiraterone acetate, the active ingredient of abiraterone acetate tablets USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet USP contains 250 mg or 500 mg of abiraterone acetate. Abiraterone is designated chemically as 17-(Pyridin-3-yl)androsta-5,16-dien-3β-yl acetate and its structure is: Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 3.57 (Log P) and Freely soluble in methylene chloride, in tetrahydrofuran, and in toluene, soluble in methanol, in ethanol, in ethyl acetate, in isobutyl methyl ketone, in N,N-dimethyl formamide and in acetone, sparingly soluble in acetonitrile and in dimethyl sulfoxide, slightly soluble in hexane, very slightly soluble in 0.1N hydrochloride and practically insoluble in water. The pKa value of abiraterone Acetate is 3.06. Abiraterone acetate tablets USP are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The film-coating contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulphate. 250 mg uncoated tablets: FDA approved dissolution test specifications differ from USP. 500 mg film-coated tablets: Meets USP dissolution test 3. abiraterone-structure

Amlodipine Besylate and Benazepril Hydrochloride AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
BLUEPOINT LABORATORIES FDA Rx Only

Amlodipine and benazepril hydrochloride capsules, USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H -1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is Its empirical formula is C 24 H 28 N 2 O 5 •HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is Its empirical formula is C 20 H 25 ClN 2 O 5 •C 6 H 6 O 3 S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. The inactive ingredients of the capsules are crospovidone, hydrophobic fumed silica, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, gelatin, titanium dioxide (not present in 10 mg/20 mg strength), black iron oxide, red iron oxide (present in 5 mg/10 mg, 5 mg/20 mg and 10 mg/ 20 mg strength), yellow iron oxide, (present in 5 mg/10 mg strength), D&C Yellow #10 (present in 5 mg/40 mg strength), FD&C Blue #1 (present in 10 mg/40 mg strength), FD&C Blue #2 (present in 10 mg/20 mg strength), FD&C Green #3 (present in 5 mg/40 mg strength),FD&C Red #40 (present in 10 mg/40 mg strength), FD&C Yellow #6 (present in 5 mg/ 40 mg strength), shellac, propylene glycol, potassium hydroxide. Benza Amlo

Anastrozole ANASTROZOLE
1 mg Tablet
BLUEPOINT LABORATORIES FDA Rx Only

Anastrozole tablets, USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C 17 H 19 N 5 and its structural formula is: Anastrozole, USP is an off-white powder with a molecular weight of 293.4. Anastrozole has moderate aqueous solubility (0.5 mg/mL at 25°C); solubility is independent of pH in the physiological range. Anastrozole is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: lactose, magnesium stearate, hydroxypropylmethylcellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide. Anastrozole Structural Formula

Antifungal Cream ANTIFUNGAL
BLUEPOINT LABORATORIES FDA OTC

Uses For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), Ringworm (tinea corporis). For the treatment of superficial skin infections caused by yeast (Candida Albicans) Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet.

Antifungal Cream ANTIFUNGAL
BLUEPOINT LABORATORIES FDA OTC

Directions Clean the affected area and dry thoroughly. Apply a thin layer of cream over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For athlete's foot: Pay special attention to spaces between the toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.

Aprepitant APREPITANT
40 mg Capsule
BLUEPOINT LABORATORIES FDA Rx Only

Aprepitant Capsules USP contain the active ingredient aprepitant, USP. Aprepitant, USP is a substance P/neurokinin 1 (NK 1 ) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2 R ,3 S )-2-[(1 R )-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3 H -1,2,4-triazol-3-one. Its empirical formula is C 23 H 21 F 7 N 4 O 3 , and its structural formula is: Aprepitant, USP is a white to off-white powder, with a molecular weight of 534.43 g/mol. It is soluble in methanol and in acetone, sparingly soluble in ethanol, and practically insoluble in water. Each capsule for oral administration contains either 40 mg, 80 mg, or 125 mg of aprepitant, USP and the following inactive ingredients: colloidal silicon dioxide, hydroxyethyl cellulose, microcrystalline cellulose, mannitol, poloxamer, povidone, sodium stearyl fumarate, vitamin E polyethylene glycol succinate, and purified water. The capsule shell excipients are gelatin, sodium lauryl sulphate and titanium dioxide. The 40 mg capsule shell also contains iron oxide yellow, and the 125 mg capsule also contains FD&C Red #3. Non-volatile solvents in the imprinting ink are shellac, iron oxide black and potassium hydroxide. USP dissolution test pending. Structure

Atovaquone and Proguanil Hydrochloride ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
BLUEPOINT LABORATORIES FDA Rx Only

Atovaquone and proguanil hydrochloride tablets (adult strength) and Atovaquone and proguanil hydrochloride pediatric tablets, for oral administration, contain a fixed-dose combination of the antimalarial agents atovaquone USP and proguanil hydrochloride USP. The chemical name of atovaquone USP is trans -2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone USP is a yellow crystalline solid that is freely soluble in N-methyl-2-pyrrolidone and in tetrahydrofuran; soluble in chloroform; sparingly soluble in acetone and dimethyl sulfoxide; slightly soluble in octanol, ethyl acetate, polyethylene glycol 200; very slightly soluble in 0.1N sodium hydroxide; insoluble in water. It has a molecular weight of 366.84 and the molecular formula C 22 H 19 ClO 3 . The compound has the following structural formula: The chemical name of proguanil hydrochloride USP is 1-(4-chlorophenyl)-5-isopropyl-biguanide hydrochloride. Proguanil hydrochloride USP is a white crystalline powder slightly soluble in water, sparingly soluble in alcohol, practically insoluble in methylene chloride. It has a molecular weight of 290.22 g/mol and the molecular formula C 11 H 16 ClN 5 •HCl. The compound has the following structural formula: Each atovaquone and proguanil hydrochloride tablet (adult strength) contains 250 mg of atovaquone USP and 100 mg of proguanil hydrochloride USP and each atovaquone and proguanil hydrochloride pediatric tablets contains 62.5 mg of atovaquone USP and 25 mg of proguanil hydrochloride USP. The inactive ingredients in the tablet are colloidal silicon dioxide, ferric oxide red, hypromellose 2910, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, poloxamer 188, polyethylene glycol 400, polyethylene glycol 8000, povidone K30, sodium starch glycolate and titanium dioxide. Atovaquone Chemical Structure Proguanil HCl Chemical Structure

Azacitidine AZACITIDINE
100 mg Injection
BLUEPOINT LABORATORIES FDA Rx Only

Azacitidine for injection contains azacitidine, which is a nucleoside metabolic inhibitor. Azacitidine is 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one. The structural formula is as follows: The empirical formula is C 8 H 12 N 4 O 5. The molecular weight is 244. Azacitidine is a white to off-white solid. Azacitidine was found to be insoluble in acetone, ethanol, and methyl ethyl ketone; slightly soluble in ethanol/water (50/50), propylene glycol, and polyethylene glycol; sparingly soluble in water, water saturated octanol, 5% dextrose in water, N-methyl-2-pyrrolidone, normal saline and 5% Tween 80 in water; and soluble in dimethylsulfoxide (DMSO). The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of Azacitidine for injection contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder. Azacitidine Structural Formula

Azacitidine AZACITIDINE
100 mg Injection
BLUEPOINT LABORATORIES FDA Rx Only

Azacitidine is a nucleoside metabolic inhibitor. The molecular formula is C 8 H 12 N 4 O 5 . The molecular weight is 244. Azacitidine is 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one. The structural formula is as follows: Azacitidine is a white to almost white powder. Azacitidine was found to be insoluble in acetone, ethanol, and methyl ethyl ketone; slightly soluble in ethanol/water (50/50), propylene glycol, and polyethylene glycol; sparingly soluble in water, water saturated octanol, 5% dextrose in water, N-methyl-2-pyrrolidone, normal saline and 5% Tween 80 in water; and soluble in dimethylsulfoxide (DMSO). Azacitidine for Injection is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Each vial of Azacitidine for Injection contains 100 mg of azacitidine, 170 mg sucrose, monosodium phosphate monohydrate and disodium hydrogen phosphate, dihydrate as a sterile lyophilized powder. 9dca4f01-figure-01

Azacitidine AZACITIDINE
100 mg Injection
BLUEPOINT LABORATORIES. FDA Rx Only

Azacitidine for injection contains azacitidine, which is a nucleoside metabolic inhibitor. Azacitidine is 4-amino-1-β-D-ribofuranosyl-1,3,5-triazin-2(1H)-one. The structural formula is as follows: The empirical formula is C 8 H 12 N 4 O 5 . The molecular weight is 244.20. Azacitidine is a white to off- white powder. Azacitidine was found to be soluble in dimethyl sulphoxide, sparingly soluble in water and insoluble in acetone and ethanol. The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Vials of azacitidine for injection contain 100 mg of azacitidine and 100 mg mannitol as a sterile lyophilized powder. structure

Bacitracin BACITRACIN
500 unit
BLUEPOINT LABORATORIES FDA OTC

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

Bacitracin Zinc FIRST AID ANTIBIOTIC
BLUEPOINT LABORATORIES FDA OTC

Uses First aid to help prevent infection in minor cuts, scrapes, and burns

bendamustine hydrochloride BENDAMUSTINE HYDROCHLORIDE
BLUEPOINT LABORATORIES FDA Rx Only

Bendamustine hydrochloride is an alkylating agent. The chemical name of bendamustine hydrochloride, USP is 1H-benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1- methyl-, monohydrochloride. Its empirical molecular formula is C 16 H 21 Cl 2 N 3 O 2 ∙ HCl, and the molecular weight is 394.7. Bendamustine hydrochloride contains a mechlorethamine group and a benzimidazole heterocyclic ring with a butyric acid substituent, and has the following structural formula: Bendamustine hydrochloride for Injection, USP (25 mg/vial or 100 mg/vial lyophilized powder) Bendamustine hydrochloride for Injection, USP for intravenous use is supplied as a sterile non-pyrogenic white to off-white lyophilized powder in a single-dose vial. Each 25-mg vial contains 25 mg of bendamustine hydrochloride, USP and 42.5 mg of mannitol, USP. Each 100-mg vial contains 100 mg of bendamustine hydrochloride, USP and 170 mg of mannitol, USP. The pH of the reconstituted solution is 2.5 to 3.5. Structural Formula

Bortezomib BORTEZOMIB
3.5 mg Injection
BLUEPOINT LABORATORIES FDA Rx Only

Bortezomib for Injection, a proteasome inhibitor, contains bortezomib which is an antineoplastic agent. Bortezomib is a modified dipeptidyl boronic acid. The chemical name for bortezomib, the monomeric boronic acid, is [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl) amino]propyl]amino]butyl] boronic acid. Bortezomib has the following chemical structure: The molecular weight is 384.24. The molecular formula is C 19 H 25 BN 4 O 4. The solubility of bortezomib, as the monomeric boronic acid, in water is 3.3 to 3.8 mg/mL in a pH range of 2 to 6.5. Bortezomib for Injection is available for intravenous injection or subcutaneous use. Each single-dose vial contains 3.5 mg of bortezomib as a sterile lyophilized powder. It also contains the inactive ingredient: 35 mg mannitol, USP. The product is provided as a mannitol boronic ester which, in reconstituted form, consists of the mannitol ester in equilibrium with its hydrolysis product, the monomeric boronic acid. The drug substance exists in its cyclic anhydride form as a trimeric boroxine. Chemical Structure

Bortezomib BORTEZOMIB
3.5 mg Injection
BLUEPOINT LABORATORIES FDA Rx Only

Bortezomib for Injection, a proteasome inhibitor, contains bortezomib which is an antineoplastic agent. Bortezomib is a modified dipeptidyl boronic acid. The chemical name for bortezomib, the monomeric boronic acid, is [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl) amino]propyl]amino]butyl] boronic acid. Bortezomib has the following chemical structure: The molecular weight is 384.24. The molecular formula is C 19 H 25 BN 4 O 4 . The solubility of bortezomib, is freely soluble in N, N dimethyl fornamide, soluble in methanol and practically insoluble in n-Hexane. Bortezomib is available for intravenous injection or subcutaneous use. Each single-dose vial contains 3.5 mg of bortezomib as a sterile lyophilized powder. It also contains the inactive ingredient: 35 mg mannitol, USP. The product is provided as a mannitol boronic ester which, in reconstituted form, consists of the mannitol ester in equilibrium with its hydrolysis product, the monomeric boronic acid. The drug substance exists in its cyclic anhydride form as a trimeric boroxine. structure

Bortezomib BORTEZOMIB
3.5 mg Injection
BLUEPOINT LABORATORIES FDA Rx Only

Bortezomib for Injection, a proteasome inhibitor, contains bortezomib which is an antineoplastic agent. Bortezomib is a modified dipeptidyl boronic acid. The chemical name for bortezomib, the monomeric boronic acid, is [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl) amino]propyl]amino]butyl] boronic acid. Bortezomib has the following chemical structure: The molecular weight is 384.24. The molecular formula is C 19 H 25 BN 4 O 4. The solubility of bortezomib, as the monomeric boronic acid, in water is 3.3 to 3.8 mg/mL in a pH range of 2 to 6.5. Bortezomib for Injection is available for intravenous injection or subcutaneous use. Each single-dose vial contains 3.5 mg of bortezomib as a sterile lyophilized powder. It also contains the inactive ingredient: 35 mg mannitol, USP. The product is provided as a mannitol boronic ester which, in reconstituted form, consists of the mannitol ester in equilibrium with its hydrolysis product, the monomeric boronic acid. The drug substance exists in its cyclic anhydride form as a trimeric boroxine. Chemical Structure

Bupropion hydrochloride BUPROPION HYDROCHLORIDE
150 mg Extended-release
BLUEPOINT LABORATORIES FDA Rx Only

Bupropion hydrochloride extended-release tablets (XL) (bupropion hydrochloride), 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-[(1,1dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13 H 18 ClNO•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 creamy-white to pale yellow round coated tablets imprinted with black ink on one side and plain on other side. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ethyl alcohol, ethylcellulose, glyceryl dibehenate, isopropyl alcohol, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, triethyl citrate. In addition, tablets are printed with black ink which contains ferrosoferric oxide, hypromellose, isopropyl alcohol and propylene glycol. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. FDA approved dissolution test specifications differ from USP. bupropion-structure.jpg

Bupropion Hydrochloride BUPROPION HYDROCHLORIDE
BLUEPOINT LABORATORIES FDA Rx Only

Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.21g/mol. The molecular formula is C 13 H 18 ClNO•HCl. Bupropion hydrochloride powder is white to off-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 is supplied for oral administration as 75-mg (orange) and 100-mg (purple) film-coated tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the following inactive ingredients: 75-mg tablet –colloidal silicon dioxide, crospovidone, FD&C Yellow #6 Aluminum Lake, fumaric acid granular, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide. 100-mg tablet –colloidal silicon dioxide, crospovidone, D&C Red #7 Calcium Lake, fumaric acid granular, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide. structure

BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE
150 mg Extended-release
BLUEPOINT LABORATORIES FDA Rx Only

Bupropion hydrochloride, 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 C 13 H 18 ClNO•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 creamy- white to pale yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: povidone, cysteine hydrochloride monohydrate, colloidal anhydrous silica, glycerol dibehanate, magnesium stearate, ethyl cellulose, polyethylene glycol, colloidal hydrated silica, triethyl citrate, methacrylic acid - ethyl acrylate copolymer, shellac, iron oxide black and propylene glycol. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. FDA approved dissolution test specifications differ from USP. Wellbutrin Chemical Structure

CAPECITABINE CAPECITABINE
150 mg Tablet
BLUEPOINT LABORATORIES FDA Rx Only

Capecitabine is a nucleoside metabolic inhibitor. The chemical name is 5’-deoxy-5-fluoro-N- [(pentyloxy) carbonyl]-cytidine and has a molecular formula of C 15 H 22 FN 3 O 6 and a molecular weight of 359.35. Capecitabine has the following structural formula: Capecitabine is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20°C. Capecitabine tablets, USP are supplied as biconvex, oblong film-coated tablets for oral administration. Each light peach-colored tablet contains 150 mg capecitabine and each peach-colored tablet contains 500 mg capecitabine. The inactive ingredients in capecitabine tablets include: anhydrous lactose, croscarmellose sodium, hypromellose, microcrystalline cellulose and magnesium stearate. The peach or light peach film coating contains hypromellose, purified talc, titanium dioxide and ferric oxide red and ferric oxide yellow. Chemical Structure

Capecitabine CAPECITABINE
150 mg Tablet
BLUEPOINT LABORATORIES FDA Rx Only

Capecitabine is a nucleoside metabolic inhibitor. The chemical name is 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular formula of C 15 H 22 FN 3 O 6 and a molecular weight of 359.35. Capecitabine has the following structural formula: Capecitabine USP is a white or almost white powder. Capecitabine USP is freely soluble in anhydrous ethanol, sparingly soluble in water and practically insoluble in heptane. Capecitabine tablets, USP are supplied as oval shaped film-coated tablets for oral use. Each light peach colored tablet contains 150 mg capecitabine, USP and each light peach colored tablet contains 500 mg capecitabine, USP. The inactive ingredients in capecitabine tablets include: croscarmellose sodium, hypromellose, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The peach or light peach film coating contains hypromellose, iron oxide red, iron oxide yellow, talc and titanium dioxide. capecitabine-str

CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA
BLUEPOINT LABORATORIES FDA Rx Only

Carbidopa and levodopa extended-release tablets USP are for the treatment of Parkinson's disease and syndrome. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (—)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C 10 H 14 N 2 O 4 •H 2 O and its structural formula is: Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (—)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C 9 H 11 NO 4 and its structural formula is: Each extended-release tablet, for oral administration, contains either 50 mg of carbidopa USP and 200 mg of levodopa USP, or 25 mg of carbidopa USP and 100 mg of levodopa USP. Inactive ingredients: microcrystalline cellulose, lactose monohydrate, hydroxypropyl methyl cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate, ferric oxide red and ferric oxide yellow. The 50 mg/200 mg tablet is supplied as an oval, scored, biconvex, compressed tablet that is peach to light peach colored. The 25 mg/100 mg tablet is supplied as an oval, biconvex, compressed tablet that is peach to light peach colored. Carbidopa and levodopa extended-release tablets USP are designed in a drug delivery system that controls the release of carbidopa and levodopa as it slowly erodes. The 25 mg/100 mg carbidopa and levodopa extended-release tablets USP is available to facilitate titration and as an alternative to the half-tablet of 50 mg/200 mg carbidopa and levodopa extended-release tablets USP. Carbidopa and levodopa extended-release tablets USP meet USP Dissolution Test 5. Carbidopa Chemical Structure Levodopa Chemical Structure

Cefdinir CEFDINIR
300 mg
BLUEPOINT LABORATORIES FDA Rx Only

Cefdinir capsules, USP contain the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α, 7β (Z)]]-7-[[(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir USP is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer. The molecular formula is C 14 H 13 N 5 O 5 S 2 and the molecular weight is 395.42. Cefdinir has the structural formula shown below: Cefdinir capsules, USP contain 300 mg cefdinir USP and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide and magnesium stearate. The empty hard gelatin capsule shells contain FD&C Blue #1, D&C Red #28, titanium dioxide, gelatin and sodium lauryl sulphate. The capsules are printed with edible ink containing black iron oxide and shellac. Chemical Structure

Cetirizine Hydrochloride (Allergy) CETIRIZINE HYDROCHLORIDE

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Cisplatin CISPLATIN
50 mg/50 ml Injection
BLUEPOINT LABORATORIES FDA Rx Only

Cisplatin injection USP, a platinum-based drug for intravenous use, is a clear, colorless to pale yellow, sterile aqueous solution. Each 50 mL or 100 mL amber vial of Cisplatin Injection, USP, contains: 1 mg/mL cisplatin USP, 9 mg/mL sodium chloride, hydrochloric acid and/or sodium hydroxide to adjust pH, and water for injection to a final volume of 50 mL or 100 mL, respectively. The pH range of Cisplatin Injection, USP, is 3.5 to 5.0. Cisplatin USP, the active ingredient in Cisplatin injection, is a yellow to orange crystalline powder with the molecular formula Cl 2 H 6 N 2 Pt and a molecular weight of 300.05. Cisplatin USP is a heavy metal complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position. It is soluble in water or saline at 1 mg/mL and in dimethylformamide at 24 mg/mL. It has a melting point of 207°C. The structural formula is: structural formula

CISPLATIN CISPLATIN
1 mg/ml
BLUEPOINT LABORATORIES FDA Rx Only

Cisplatin Injection is a clear, colorless to pale yellow solution. Each 100 mL amber vial of Cisplatin Injection contains: 1 mg/mL cisplatin USP, 9 mg/mL sodium chloride, hydrochloric acid and/or sodium hydroxide to adjust pH, and water for injection to a final volume of 50 mL and 100 mL respectively. The pH range of Cisplatin Injection is 3.8 to 5.9. Cisplatin Injection must be further diluted prior to administration (see DOSAGE AND ADMINISTRATION , All Patients ). The active ingredient, cisplatin USP, is a yellow to orange crystalline powder. Cisplatin is a heavy metal complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position. It is soluble in water or saline at 1 mg/mL and in dimethylformamide at 24 mg/mL. It has a melting point of 207°C. PtCl 2 H 6 N 2 M.W. 300.05 cisplatin-spl-structure

Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE
BLUEPOINT LABORATORIES FDA Rx Only

Clonidine hydrochloride, USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg, and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The following inactive ingredients are contained in these products: corn starch, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake (Sunset Yellow Lake), lactose monohydrate, magnesium stearate, and sodium starch glycolate. Clonidine hydrochloride, USP is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula: Clonidine hydrochloride, USP is an odorless, bitter, white, crystalline substance soluble in water and alcohol. 18ddb7fd-figure-01

Clonidine hydrochloride CLONIDINE HYDROCHLORIDE
0.1 mg Extended-release
BLUEPOINT LABORATORIES FDA Rx Only

Clonidine hydrochloride extended-release tablets, USP are a centrally acting alpha 2 -adrenergic agonist available as 0.1 mg extended-release tablets for oral administration. Each 0.1 mg tablet is equivalent to 0.087 mg, respectively, of the free base. The inactive ingredients are sodium lauryl sulfate, microcrystalline cellulose, hypromellose, colloidal silicon dioxide, and magnesium stearate. The formulation is designed to delay the absorption of active drug in order to decrease peak to trough plasma concentration differences. Clonidine hydrochloride, USP is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)2-imidazoline hydrochloride. The following is the structural formula: C 9 H 9 Cl 2 N 3 •HCl Mol. Wt. 266.56 Clonidine hydrochloride, USP is an odorless, bitter, white, crystalline substance soluble in water and alcohol. clonidine_structure

Cyanocobalamin CYANOCOBALAMIN
1000 mcg/ml
BLUEPOINT LABORATORIES FDA Rx Only

Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1,000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%, is present as a preservative. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B 12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C 63 H 88 CoN 14 O 14 P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below. Structural Formula

Cyanocobalamin CYANOCOBALAMIN
1000 mcg/ml
BLUEPOINT LABORATORIES FDA Rx Only

Cyanocobalamin injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1,000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.50%. Benzyl Alcohol, 1.5%, is present as a preservative. Sodium acetate and glacial acetic acid are present as buffer. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). The vitamin B 12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C 63 H 88 CoN 14 O 14 P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below. structure

CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE
200 mg/ml Injection
BLUEPOINT LABORATORIES FDA Rx Only

Cyclophosphamide is an alkylating drug. It is an antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula: Cyclophosphamide has a molecular formula of C 7 H 15 Cl 2 N 2 O 2 P•H 2 O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. Cyclophosphamide Injection is a 200 mg/mL sterile clear colorless solution available as 1 g and 2 g strength vials. 1 g vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide, 3.1 g Ethanol, 0.17 g Propylene Glycol, 0.17 g Polyethylene glycol 400 and 0.69 mg Monothioglycerol. 2 g vial contains 2138.0 mg cyclophosphamide monohydrate equivalent to 2 g cyclophosphamide, 6.2 g Ethanol, 0.34 g Propylene glycol, 0.34 g Polyethylene glycol 400 and 1.38 mg Monothioglycerol. Structure

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