marlex pharmaceuticals, inc. - Medication Listings

Browse 53 medications manufactured by marlex pharmaceuticals, inc.. Open a product record to review dosage forms, strengths, packaging, and related navigation.

METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE
#4 500 mg Extended-release
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Metformin Hydrochloride Extended-Release Tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below: Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4 H 11 N 5 •HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-Release Tablets USP, 500 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose and povidone. Metformin Hydrochloride Extended-Release Tablets USP, 750 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, red iron oxide and yellow iron oxide. System Components and Performance – Metformin Hydrochloride Extended-Release Tablets USP is based on a hydrophilic polymer matrix drug delivery system. On oral administration, fluid from the gastrointestinal tract wets and penetrates the matrix leading to the formation of a hydrogel and swelling of the polymer matrix. Drug is released slowly over time in a controlled manner, independent of pH, by a process of drug dissolution followed by drug diffusion through the hydrogel barrier formed and gradual matrix erosion. Metformin Hydrochloride Extended-Release Tablets USP meets USP Dissolution Test 6. metformin-er-structure

Prednisone PREDNISONE
#19 2.5 mg
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Prednisone Tablets, USP are available for oral administration containing 2.5 mg, 5 mg, 10 mg, 20 mg and 50 mg of prednisone, USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and sodium starch glycolate. Prednisone Tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy-. The structural formula is represented below: Molecular Formula: C21H26O5 Molecular Weight: 358.44 Prednisone is a white or almost white crystalline powder. It is slightly soluble in acetone, ethanol, ethylacetate and methanol. Meets USP Dissolution Test 2. structure

Acetaminophen ACETAMINOPHEN
#34 500 mg
MARLEX PHARMACEUTICALS INC FDA OTC

Uses Temporary relieves minor aches and pains due to: The common cold • Headache Backache • Minor pain of arthritis Toothache • Muscular aches Premenstrual and menstrual cramps * Temporarily reduces fever

Acetaminophen 325mg ACETAMINOPHEN
MARLEX PHARMACEUTICALS INC FDA OTC

Uses To reduce fever and for the temporary relief of minor aches and pains due to: Headache Backache The common cold Premenstrual and menstrual cramps Temporarily reduces fever Muscular ache Minor pain of arthritis Toothache

Acetazolamide ACETAZOLAMIDE
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Acetazolamide, an inhibitor of the enzyme carbonic anhydrase, is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2-yl)-acetamide and has the following chemical structure: Molecular Weight: 222.24 Molecular Formula: C 4 H 6 N 4 O 3 S 2 Acetazolamide is available as oral tablets containing 125 mg and 250 mg of acetazolamide, respectively, and the following inactive ingredients: povidone, croscarmellose sodium, purified water, lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, talc and magnesium stearate. acetazolamide-structure

Alendronate ALENDRONATE SODIUM
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The molecular formula of alendronate sodium is C 4 H 12 NNaO 7 P 2 •3H 2 O and its formula weight is 325.12. The structural formula is: Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Alendronate sodium tablets, USP for oral administration contain 6.53, 13.06, 45.69, or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5 mg, 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: microcrystalline cellulose, Croscarmellose sodium, and magnesium stearate. structure

Amantadine Hydrochloride AMANTADINE HYDROCHLORIDE
MARLEX PHARMACEUTICALS INC FDA Rx Only

Amantadine hydrochloride is designated generically as amantadine hydrochloride and chemically as 1-adamantanamine hydrochloride. C10H17N•HCl Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Each tablet intended for oral administration contains 100 mg amantadine hydrochloride and has the following inactive ingredients: microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate, and colloidal silicon dioxide. Each capsule intended for oral administration contains 100 mg amantadine hydrochloride and has the following inactive ingredients: magnesium stearate, microcrystalline cellulose, Povidone, Sodium Starch Glycolate, Colloidal Silicon Dioxide. The capsule shells and imprinting ink contain FD&C Blue #1, FD&C Red #40, gelatin, FD&C Yellow #6, sodium lauryl sulfate, and titanium dioxide. Chemical Structure

Aspirin ASPIRIN
81 mg
MARLEX PHARMACEUTICALS INC. FDA OTC

Uses · Temporarily relieves minor aches and pains. · For other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

ATENOLOL AND CHLORTHALIDONE ATENOLOL AND CHLORTHALIDONE
MARLEX PHARMACEUTICALS, INC FDA Rx Only

Atenolol and Chlorthalidone Tablets, USP are for the treatment of hypertension. It combines the antihypertensive activity of two agents: a beta1-selective (cardioselective) hydrophilic blocking agent (atenolol) and a monosulfonamyl diuretic (chlorthalidone). Atenolol is Benzeneacetamide, 4-[2'-hydroxy-3'-[(1-methylethyl) amino] propoxy]-. Atenolol (free base) is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Chlorthalidone is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl) benzene sulfonamide: Chlorthalidone has a water solubility of 12 mg/100 mL at 20°C. Each Atenolol and Chlorthalidone Tablet, USP 100 mg/25 mg contains: Atenolol, USP .......................................100 mg Chlorthalidone, USP .............................25 mg Each Atenolol and Chlorthalidone Tablet, USP 50 mg/25 mg contains: Atenolol, USP .........................................50 mg Chlorthalidone, USP ..........................................................25 mg Inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate. struct-at struct-chlor

Baclofen BACLOFEN
MARLEX PHARMACEUTICALS INC FDA Rx Only

Baclofen USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(-4-chlorophenyl)-butanoic acid. The structural formula is: Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 10 mg or 20 mg baclofen. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, and magnesium stearate. The structural formula of Baclofen.

Bisoprolol Fumarate and Hydrochlorothiazide BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Bisoprolol fumarate and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta 1 -selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl] phenoxy]-3-[(1-methylethyl)amino]-2-propanol( E )-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C 18 H 31 NO 4 ) 2 •C 4 H 4 O 4 and it has a molecular weight of 766.97. Its structural formula is: Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1- dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 and it has a molecular weight of 297.73. Its structural formula is: Each bisoprolol fumarate and hydrochlorothiazide - 2.5 mg/6.25 mg tablet, USP for oral administration contains: Bisoprolol fumarate…………………………………………..2.5 mg Hydrochlorothiazide………………………………………..6.25 mg Each bisoprolol fumarate and hydrochlorothiazide - 5 mg/6.25 mg tablet, USP for oral administration contains: Bisoprolol fumarate…………………………………………… 5 mg Hydrochlorothiazide……………………………………….. 6.25 mg Each bisoprolol fumarate and hydrochlorothiazide - 10 mg/6.25 mg tablet, USP for oral administration contains: Bisoprolol fumarate…………………………………………...10 mg Hydrochlorothiazide……………………………………….. 6.25 mg Inactive ingredients include pregelatinized starch, anhydrous dicalcium phosphate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide. The 10 mg/6.25mg tablet also contains FD&C blue #1 aluminum lake. The 5 mg/6.25 mg tablet also contains iron oxide red & ferrosoferric oxide. The 2.5 mg/6.25 mg tablet also contains ferric oxide. FDA approved dissolution test specifications differ from USP. Bisoprolol-Fumarate thiazide-structure

Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE
MARLEX PHARMACEUTICALS, INC FDA OTC

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

Clotrimazole CLOTRIMAZOLE
MARLEX PHARMACEUTICALS INC FDA OTC

Uses Cures most Athlete's foot (tinea pedis) Jock Itch (tinea cruris) Ringworm (tinea corporis) Effectively relieves Itching Cracking Burning Discomfort which can accompany these conditions

Desvenlafaxine DESVENLAFAXINE
50 mg Extended-release
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Desvenlafaxine extended-release is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C 16 H 25 NO 2 (free base) and C 16 H 25 NO 2 •C 4 H 6 O 4 •H 2 O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine extended-release is formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 50 mg tablet and 100 mg tablet consist of hypromellose, hydroxyethyl cellulose, ethyl cellulose, microcrystalline cellulose, magnesium stearate and film coatings, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides. DEVStructure

Dexamethasone DEXAMETHASONE
MARLEX PHARMACEUTICALS, INC FDA Rx Only

Each 5 mL (teaspoonful) contains: Dexamethasone, USP……………………………………0.5 mg Also Contains: Benzoic Acid, USP………………………………………. .0.1% (as a preservative) Alcohol………………………………………………………5% Inactive Ingredients: Artificial raspberry flavor, citric acid, edetate disodium, FD&C Red #40, propylene glycol, purified water, saccharin sodium, sorbitol solution. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The molecular formula is C 22 H 29 FO 5 and the structural formula is: structural formula

Diclofenac Potassium DICLOFENAC POTASSIUM
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Diclofenac potassium tablets, USP are a benzeneacetic acid derivative. Diclofenac potassium tablets are available for oral administration. Diclofenac potassium, USP is a white to off-white or slightly yellowish crystalline powder and is sparingly soluble in water at 25ºC. The chemical name is Potassium [ o -(2,6-dichloroanilino)phenyl] acetate. The molecular weight is 334.24. Its molecular formula is C 14 H 10 Cl 2 KNO 2, and it has the following structural formula: The inactive ingredients in diclofenac potassium tablets include: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, glyceryl triacetate, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate and titanium dioxide. Diclofenac Potassium Structural Formula

Digoxin DIGOXIN
125 mcg Tablet
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata . The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[( O -2,6-dideoxy-β- D-ribo -hexopyranosyl-(1→4)- O - 2,6-dideoxy-β- D-ribo- hexopyranosyl-(1→4)-2,6-dideoxy-β- D - ribo -hexopyranosyl)oxy]-12,14- dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is: Digoxin exists as white or almost white powder or colorless crystals. The drug is practically insoluble in water; soluble in mixture of methanol & methylene chloride and slightly soluble in ethyl alcohol. Digoxin is supplied as, 125 mcg (scored), and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, lactose anhydrous, magnesium stearate. The 125 mcg tablets additionally contain yellow iron oxide. FDA approved dissolution test specifications differ from USP. structure

Doxepin DOXEPIN
3.39 mg Tablet
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Doxepin Tablets are available in 3 mg and 6 mg strengths for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1-propanamine, 3-dibenz[ b,e ]oxepin-11(6 H )ylidene- N , N -dimethyl-hydrochloride. It has the following structure: Doxepin hydrochloride, USP is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C19H21NO•HCl. Each doxepin tablet includes the following inactive ingredients: colloidal silicon dioxide, FD&C Blue No. 1 Aluminum Lake, magnesium stearate and microcrystalline cellulose. structure

ETHAMBUTOL HYDROCHLORIDE ETHAMBUTOL HYDROCHLORIDE
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

ETHAMBUTOL HYDROCHLORIDE is an oral chemotherapeutic agent which is specifically effective against actively growing microorganisms of the genus Mycobacterium, including M. tuberculosis. The structural formula is: ETHAMBUTOL HYDROCHLORIDE (HCL) 100 and 400 mg tablets contain the following inactive ingredients: Gelatin, Hydroxypropyl Methylcellulose, Magnesium Stearate, Sodium Lauryl Sulfate, Sorbitol, Stearic Acid, Sucrose, Titanium Dioxide and other ingredients. structural formula

Ezetimibe EZETIMIBE
10 mg Tablet
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Ezetimibe is a dietary cholesterol absorption inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C 24 H 21 F 2 NO 3 . Its molecular weight is 409.4 and its structural formula is: Ezetimibe is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe is available as a tablet for oral administration containing 10 mg of ezetimibe and the following inactive ingredients: mannitol, microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulfate, magnesium stearate, anhydrous citric acid. structural formula

FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 4-[3-[2-(Trifluoromethyl) phenothiazin-10-yl] propyl]-1- piperazineethanol Dihydrochloride. The structural formula is represented below: 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 FD&C Ye low #6 (1 mg tablet), FD&C Red #40 (1 mg tablet), lactose monohydrate, magnesium stearate, polysorbate 80, dibasic calcium phosphate dihydrate, pregelatinized starch, purified water, microcrystalline cellulose, croscarmellose sodium. structure

Guaifenesin 200mg GUAIFENESIN
MARLEX PHARMACEUTICALS INC FDA OTC

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive

Guaifenesin 400mg GUAIFENESIN
MARLEX PHARMACEUTICALS INC FDA OTC

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive

Haloperidol HALOPERIDOL
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4’—fluorobutyrophenone and it has the following structural formula: Haloperidol is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, pregelatinized starch. In addition, the 1 mg, 5 mg and 10 mg tablets contain D&C Yellow No. 10 Aluminum Lake. The 5 mg and 10 mg tablets contain FD&C Blue No. 1 Aluminum Lake, 20 mg tablets contain FD&C Red No. 40 Aluminum Lake. structure

Hydrocortisone Acetate HYDROCORTISONE ACETATE
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Each Hydrocortisone Acetate Suppository for rectal administration contains hydrocortisone acetate USP in a hydrogenated palm kernel oil base. Hydrocortisone acetate is a corticosteroid. The molecular weight of hydrocortisone acetate is 404.50. Chemically, hydrocortisone acetate is pregn-4-ene-3, 20 dione, 21- (acetyloxy)-11, 17-dihydroxy-, (11β)- with an empirical formula of C23 H32O6 and the following structural formula: struct

hydroquinone HYDROQUINONE
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Each gram of HYDROQUINONE USP, 4% SKIN BLEACHING CREAM contains 40 mg hydroquinone, in a cream base of Glyceryl Monostearate, Mineral Oil, PEG-25 Propylene Glycol Stearate, Polyoxl-40 Stearate, Propylene Glycol, Propylparaben, Purified water, sodium metabisulfite, Squalane and Stearic Acid. Chemically, hydroquinone is C 6 H 6 O 2 and has a molecular weight of 110.11. The chemical name is 1,4 dihydroxybenzene, and the structural formula of hydroquinone is: structure

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-( p -Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C 21 H 27 CIN 2 O 2 . 2HCl M.W. 447.83 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 hydrochloride, USP. lnactive ingredients include: carnauba wax, colloidal sllicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. hydroxyzinehcl-structure

isoniazid ISONIAZID
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Isoniazid is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose and stearic acid. Isoniazid is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has an empirical formula of C 6 H 7 N 3 O and a molecular weight of 137.14. It has the following structure: Isoniazid is odorless and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol, and slightly soluble in chloroform and in ether. Isoniazid is slowly affected by exposure to air and light. isoniazid chemical structure

Labetalol Hydrochloride LABETALOL
MARLEX PHARMACEUTICALS INC FDA Rx Only

Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha 1 -adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1- methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure: Labetalol hydrochloride, USP has the molecular formula C 19 H 24 N 2 O 3 •HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R’ stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets, USP, for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each 100 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), red iron oxide, titanium dioxide and yellow iron oxide. In addition, each 200 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, pregelatinized starch (corn), titanium dioxide and triacetin. In addition, each 300 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, FD&C Blue #2, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), titanium dioxide. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1- methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structur

Lacosamide LACOSAMIDE
50 mg Tablet
MARLEX PHARMACEUTICALS, INC FDA Rx Only

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. Freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile and practically insoluble in heptane. 11.1 Lacosamide tablets, USP Lacosamide tablets for oral administration contain lacosamide and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, lecithin and dye pigments as specified below: Lacosamide tablets are supplied as debossed tablets and contain the following coloring agents: 50 mg tablets: red iron oxide, black iron oxide, FD&C Blue #2/indigo carmine aluminum lake 100 mg tablets: yellow iron oxide 150 mg tablets: yellow iron oxide, red iron oxide, black iron oxide 200 mg tablets: FD&C Blue #2/indigo carmine aluminum lake lacosamide-01

Levocetirizine Dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE
MARLEX PHARMACEUTICALS INC FDA Rx Only

Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets USP, 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 Renantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The molecular 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 is a white to off white crystalline powder and is water soluble. Levocetirizine dihydrochloride tablets USP 5 mg are formulated as immediate release, white to off white, oval shaped biconvex, film-coated tablet for oral administration. The tablets are debossed with 'I' and '12' on one side and score line on the other side. Inactive ingredients are: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol. The chemical structure for Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets USP, 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 molecular formula of levocetirizine dihydrochloride is C 21H 25ClN 2O 3•2HCl.

Lidocaine LIDOCAINE
MARLEX PHARMACEUTICALS INC FDA OTC

Use for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations

Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Lidocaine Hydrochloride Topical Solution, USP contains a local anesthetic agent and is administered topically. See INDICATIONS for specific uses. Each mL contains: Lidocaine Hydrochloride, USP ................................................................................... 40 mg Methylparaben, Sodium Hydroxide (to adjust pH) in an aqueous solution. NOT FOR INJECTION. Lidocaine is a local anesthetic chemically designated as 2-(diethylamino)-N-(2,6-dimethyl-phenyl)-acetamide. It has the following structural formula: structure

Loratadine Allergy Relief LORATADINE
MARLEX PHARMACEUTICALS, INC. FDA OTC

Uses 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

Magnesium Oxide MAGNESIUM OXIDE
MARLEX PHARMACEUTICALS INC FDA OTC

USES relieves acid indigestion upset stomach

magnesium oxide MAGNESIUM OXIDE
MARLEX PHARMACEUTICALS INC. FDA OTC

SUGGESTED USE As a dietary supplements, adult take one (1) tablet daily preferably with food or as directed by your healthcare practitioner.

Menthol and Zinc Oxide MENTHOL AND ZINC OXIDE
MARLEX PHARMACEUTICALS, INC. FDA OTC

Uses A moisture barrier that prevents & helps heal skin irritations from: Urine Diarrhea Perspiration Fistula drainage Feeding tube site leakage Wound drainage (peri-wound skin) Minor burns Cuts Scrapes Itching

Methocarbamol Tablets, USP, 500 mg, Methocarbamol Tablets, USP, 750 mg METHOCARBAMOL
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Methocarbamol Tablets, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n -hexane. Methocarbamol Tablets, USP 500 mg are available as a white, round, scored, film-coated tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, povidone (k-30), sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80. Methocarbamol Tablets, USP 750 mg are available as a white, capsule-shaped, film-coated tablet containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, povidone (k-30), sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80. Methocarbamol structural formula

METOLAZONE METOLAZONE
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Metolazone tablets, USP, for oral administration contain 2.5, 5, or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16 H 16 ClN 3 O 3 S, the chemical name 7-chloro-1, 2, 3, 4- tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide, and a molecular weight of 365.83. The structural formula is: Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide and dye: 2.5 mg - FD&C Red No. 40 and FD&C Blue No. 2; 5 mg - FD&C Blue No. 2; 10 mg - D&C Yellow No. 10. undefined

Miconazole Nitrate Antifungal Powder MICONAZOLE NITRATE ANTIFUNGAL
MARLEX PHARMACEUTICALS, INC. FDA OTC

Uses For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) For the treatment of most superficial skin infections caused by yeast (candida albicans) Relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Oxcarbazepine OXCARBAZEPINE
300 mg/5 ml Suspension
MARLEX PHARMACEUTICALS, INC FDA Rx Only

Oxcarbazepine is an AED available as a 300 mg/5 mL (60 mg/mL) oral suspension for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo- 5 H -dibenz[b, f ]azepine-5-carboxamide, and its structural formula is: Oxcarbazepine, USP is a light orange to creamish white or off white powder. It is soluble in acetic acid; sparingly soluble in chloroform, in chloromethane; practically insoluble in water. Its molecular weight is 252.27 g/mol. Oxcarbazepine oral suspension, USP contains the following inactive ingredients: ascorbic acid; microcrystalline cellulose and carboxymethyl cellulose sodium; xanthan gum; polyoxyl stearate type-I; methyl paraben; propylene glycol; propyl paraben; purified water; sodium saccharin; sorbic acid; sorbitol solution 70% non-crystallizing; plum flavor 0527036. FDA approved dissolution test specifications differ from USP. Oxcarbazepine-7

Potassium Chloride for Oral Solution POTASSIUM CHLORIDE FOR ORAL
MARLEX PHARMACEUTICALS INC FDA Rx Only

Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Oral Solution: 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, natural/artificial orange flavor, purified water, methylparaben, propyl paraben, trisodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, natural/artificial orange flavor, purified water, methylparaben, propyl paraben, trisodium citrate dihydrate, sucralose.

Potassium Chloride for Oral Solution POTASSIUM CHLORIDE FOR ORAL
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Each pouch of light pink to orange powder contains 1.5 g of potassium chloride, USP, which is equivalent to potassium 20 mEq and chloride 20 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&C Yellow #6, natural and artificial orange flavor, and sucralose.

Probenecid PROBENECID
MARLEX PHARMACEUTICALS INC FDA Rx Only

Probenecid is a uricosuric and renal tubular transport blocking agent. The chemical name for probenecid is 4-[(dipropylamino) sulfony1] benzoic acid. It has the following structural formula: Probenecid, USP is a white or nearly white, fine, crystalline powder. Probenecid is soluble in dilute alkali, in alcohol, in chloroform, and in acetone; it is practically insoluble in water and in dilute acids. Each tablet for oral administration contains 500 mg of probenecid and the following inactive ingredients: Microcrystalline cellulose, corn starch, sodium starch glycolate, povidone, colloidal silicon dioxide, magnesium stearate, sodium lauryl sulfate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, and FD&C Blue #2 Aluminum Lake. the following structural formula for probenecid is 4-[(dipropylamino) sulfony1] benzoic acid.

PYRAZINAMIDE PYRAZINAMIDE
MARLEX PHARMACEUTICALS, INC FDA Rx Only

Pyrazinamide, the pyrazine analogue of nicotinamide, is an antituberculous agent. It is a white crystalline powder, stable at room temperature, and sparingly soluble in water. Pyrazinamide has the following structural formula: Each pyrazinamide tablet for oral administration contains 500 mg of pyrazinamide and the following inactive ingredients: Corn Starch, Magnesium Stearate, Pregelatinized Starch and Stearic Acid. struct

Regadenoson REGADENOSON
0.4 mg/5 ml Injection
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Regadenoson is an A 2A adenosine receptor agonist that is a coronary vasodilator [ see Clinical Pharmacology ( 12.1 ) ]. Regadenoson is chemically described as adenosine, 2-{4-[(methylamino) carbonyl] - 1h-pyrazol-1-yl} adenosine propane-1,2-diol. Its structural formula is: The molecular formula for regadenoson is C 15 H 18 N 8 O 5 .C 3 H 8 O 2 and its molecular weight is 466.45. Regadenoson injection is a sterile, nonpyrogenic solution for intravenous injection. The solution is clear and colorless. Each 1 mL in the 5 mL pre-filled syringe contains equivalent of 0.08 mg regadenoson as regadenoson propylene glycol solvate, 10.9 mg dibasic sodium phosphate dihydrate, 5.4 mg monobasic sodium phosphate monohydrate, 150 mg propylene glycol, 1 mg edetate disodium dihydrate, and Water for Injection, with pH between 6.3 and 7.7. regadenoson-structure

Rifabutin RIFABUTIN
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Rifabutin Capsules for oral administration contain 150 mg of the rifamycin antimycobacterial agent rifabutin, USP, per capsule along with the inactive ingredients, microcrystalline cellulose, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate. The hard gelatin capsule contains titanium dioxide, red iron oxide, gelatin, sodium lauryl sulfate and purified water. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. The chemical name for rifabutin is 1',4-didehydro-1-deoxy-1,4-dihydro-5'-(2- methylpropyl)-1-oxorifamycin XIV (Chemical Abstracts Service, 9th Collective Index) or (9 S ,12 E ,14 S ,15 R , 16 S ,17 R ,18 R ,19 R ,20 S ,21 S ,22 E , 24 Z )-6,16,18,20-tetrahydroxy-1'- isobutyl-14-methoxy- 7,9,15,17,19,21,25-heptamethyl-spiro [9,4- (epoxypentadeca[1,11,13]trienimino)-2 H - furo[2',3':7,8]naphth[1,2-d] imidazole-2,4'- piperidine]-5,10,26-(3 H ,9 H )-trione-16-acetate. Rifabutin has a molecular formula of C 46 H 62 N 4 O 11 , a molecular weight of 847.02 and the following structure: Rifabutin is a red-violet powder soluble in methanol, slightly soluble in ethanol, and slightly soluble in water (0.21 mg/mL). Its log P value (the base 10 logarithm of the partition coefficient between n-octanol and water) is 3.2 (n-octanol/water). FDA approved dissolution method differs from the current USP monograph dissolution method. structure

Ropinirole ROPINIROLE
0.25 mg Tablet
MARLEX PHARMACEUTICALS INC FDA Rx Only

Ropinirole tablets, USP are an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino) ethyl]-1, 3-dihydro-2H-indol-2-one monohydrochloride and has an empirical formula of C 16 H 24 N 2 O•HCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is: Ropinirole hydrochloride is an off white to light yellow, crystalline powder with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each pentagonal film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and one or more of the following: carmine, ferric ferrous oxide, ferric oxide red, ferric oxide yellow and indigotine aluminum lake. Meets USP Dissolution Test #2 structure

Selegiline Hydrochloride SELEGILINE HYDROCHLORIDE
MARLEX PHARMACEUTICALS, INC. FDA Rx Only

Selegiline hydrochloride, USP is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l-deprenyl. The chemical name is: (R)-(-)-N,2-dimethyl-N-2-propynylphenethylamine hydrochloride. It is a white to near white crystalline powder, freely soluble in water, chloroform, and methanol, and has a molecular weight of 223.75. The molecular formula is C 13 H 17 N.HCI and the structural formula is as follows: Each hard gelatin capsule with white opaque cap and white opaque body imprinted "Novitium 5 mg" on the body and "504" on the cap in red ink containing white to off- white powder. Each capsule contains 5 mg selegiline hydrochloride, USP. Inactive ingredients are citric acid anhydrous, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The capsule shells contain gelatin and titanium dioxide and are imprinted with red ink. The imprinting ink contains shellac, alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, sodium hydroxide, titanium dioxide, povidone and FD&C Red #40, Aluminum Lake. struct

Senna S DOCUSATE SODIUM AND SENNOSIDES
MARLEX PHARMACEUTICALS INC FDA OTC

Uses relieves occasional constipation (irregularity) generally causes bowel movement in 6-12 hours

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