chartwell rx, llc - Medication Listings

Browse 273 medications manufactured by chartwell rx, llc. Open a product record to review dosage forms, strengths, packaging, and related navigation.

Hydroxyzine pamoate HYDROXYZINE PAMOATE
CHARTWELL RX, LLC FDA Rx Only

Hydroxyzine pamoate is a light yellow odorless powder, practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1- piperazinyl]ethoxy]ethanol 4,4 -methylenebis[3-hydroxy-2-naphthoate] (1:1) and can be structurally represented as follows: Chemical Formula: C 21 H 27 ClN 2 O 2 .C 23 H 16 O 6 Molecular Weight: 763.29 Inert ingredients for the capsule formulations are: hard gelatin capsules (which contain gelatin, titanium dioxide, FD&C Blue #1, FD&C Red #40, D&C Yellow #10), printing ink which contains shellac glaze ~45% (20% esterified) in Ethanol, iron oxide black, n-butyl alcohol, isopropyl alcohol, propylene glycol and ammonium hydroxide 28%); magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate. "Image Description"

Hyoscyamine Sulfate, Hyoscyamine sulfate, Hyoscyamine sulfate Sublingual HYOSCYAMINE SULFATE
CHARTWELL RX, LLC FDA Rx Only

Hyoscyamine Sulfate Oral Drops (Hyoscyamine Sulfate Oral Solution, USP) contains 0.125 mg hyoscyamine sulfate per mL with 5% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Elixir, USP (Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine sulfate per 5 mL with 20% v/v ethyl alcohol for oral administration. Hyoscyamine Sulfate Tablets, USP contain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Sublingual Tablets contain 0.125 mg hyoscyamine sulfate for sublingual administration. However, the tablets may be chewed or taken orally. Hyoscyamine Sulfate Orally Disintegrating Tablets contain 0.125 mg hyoscyamine sulfate formulated for oral administration. Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg disintegrate within seconds after placement on the tongue, allowing them to be swallowed with or without water. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17 H 23 NO 3 ) 2 • H 2 SO 4 • 2H 2 O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, (α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-,sulfate (2:1), dihydrate with the following structure: Hyoscyamine Sulfate Oral Drops also contain as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, sodium benzoate, sodium citrate, sorbitol solution, sucrose, and water. Hyoscyamine Sulfate Elixir also contains as inactive ingredients: Ethyl alcohol, citric acid, FD&C red #40, FD&C yellow #6, lemon flavor, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, and sucrose. Hyoscyamine Sulfate Tablets also contain as inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Hyoscyamine Sulfate Sublingual Tablets also contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate. Hyoscyamine Sulfate Orally Disintegrating Tablets also contain as inactive ingredients: Mannitol, sorbitol, crospovidone, artificial strawberry flavor, colloidal silicon dioxide, sodium stearyl fumarate, and magnesium stearate. "Structure"

Hyoscyamine sulfate HYOSCYAMINE SULFATE
CHARTWELL RX, LLC FDA Rx Only

Hyoscyamine Sulfate Extended-Release Tablets contain 0.375 mg of hyoscyamine sulfate in a formulation designed for oral b.i.d. dosage. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C 17 H 23 NO 3 ) 2 • H 2 SO 4 • 2H 2 O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, (α-(hydroxymethyl)-,8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-,sulfate (2:1), dihydrate with the following structure: Hyoscyamine Sulfate Extended-Release Tablets also contain as inactive ingredients: microcrystalline cellulose, Hydroxypropyl cellulose, colloidal silicon dioxide, and magnesium stearate. image description

Imatinib Mesylate IMATINIB MESYLATE
100 mg Tablet
CHARTWELL RX, LLC FDA Rx Only

Imatinib Mesylate Tablets, is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets contain imatinib mesylate equivalent to 100 mg or 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is: Imatinib Mesylate, is a off white to pale yellow granular powder. Its molecular formula is C 29 H 31 N 7 O•CH 4 SO 3 and its molecular weight is 589.7. Imatinib mesylate, is soluble water, slightly soluble in methanol and dimethyl sulphoxide. Inactive Ingredients: magnesium stearate and povidone. Tablet coating: ferric oxide yellow #6, hypromellose, polyethylene glycol, and titanium dioxide. image description

INDOMETHACIN INDOMETHACIN
CHARTWELL RX, LLC FDA Rx Only

Indomethacin capsules, USP for oral administration contains 25 mg of indomethacin. Each capsule contains the following inactive ingredients: corn starch, croscarmellose sodium, lactose monohydrate, polyethylene glycol 4000, stearic acid, and talc. The capsule shell contains D&C Yellow #10, FD&C Green #3, gelatin, and titanium dioxide. The black imprinting ink contains alcohol, black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, ferrosoferric oxide, n-butyl alcohol, propylene glycol, and shellac glaze. Indomethacin is a nonsteroidal anti-inflammatory indole derivative designated chemically as 1 – (4-chlorobenzoyl)-5-methoxy-2-methyl-1 H -indole-3-acetic acid. The structural formula is: Indomethacin is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The molecular weight of indomethacin is 357.79 and its molecular formula is C 19 H 16 C 1 NO 4 image description

Indomethacin INDOMETHACIN
50 mg Capsule
CHARTWELL RX, LLC FDA Rx Only

Indomethacin Capsules are nonsteroidal anti-inflammatory drugs, available as capsules containing 50 mg of indomethacin, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1 H -indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C 19 H 16 C l NO 4 , and it has the following chemical structure. Indomethacin is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in Indomethacin Capsules 50 mg include: lactose monohydrate, corn starch, croscarmellose sodium, polyethylene glycol, stearic acid, talc, gelatin, titanium dioxide, D&C Yellow #10, and FD&C Green #3. Black printing ink contains shellac, black iron oxide, n-butyl alcohol, ethanol, methanol, propylene glycol, FD&C Blue #2, FD&C Red #40, D&C Yellow #10, and FD&C Blue #1. image description

Ipratropium Bromide IPRATROPIUM BROMIDE
CHARTWELL RX, LLC FDA Rx Only

The active ingredient in ipratropium bromide inhalation solution is ipratropium bromide monohydrate. It is an anticholinergic bronchodilator chemically described as 8-Azoniabicyclo [3.2.1]-octane,-3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate ( endo, syn )-,(±)-; a synthetic quaternary ammonium compound, chemically related to atropine. Ipratropium bromide is a white crystalline substance, freely soluble in water and lower alcohols. It is a quaternary ammonium compound and thus exists in an ionized state in aqueous solutions. It is relatively insoluble in non-polar media. Ipratropium bromide inhalation solution is administered by oral inhalation with the aid of a nebulizer. Each mL contains ipratropium bromide 0.02% (anhydrous basis) in a sterile, preservative-free, isotonic saline solution, pH-adjusted to 3.4 (3 to 4) with hydrochloric acid. image description

Ipratropium Bromide and Albuterol Sulfate IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE
CHARTWELL RX, LLC FDA Rx Only

The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are albuterol sulfate and ipratropium bromide. Albuterol sulfate is a salt of racemic albuterol and a relatively selective β 2-adrenergic bronchodilator chemically described as α 1-[( tert -Butylamino) methyl]-4-hydroxy- m -xylene- α,α′-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13 H 21 NO 3 ) 2 •H 2 SO 4 . It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization’s recommended name for albuterol base is salbutamol. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo[3.2.1]-octane,3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo,syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C 20 H 30 BrNO 3 •H 2 O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution contains 3 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride and hydrochloric acid to adjust to pH 4. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus™ nebulizer (with face mask or mouthpiece) connected to a PRONEB™ compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION ). image description image description

IRBESARTAN IRBESARTAN
75 mg Tablet
CHARTWELL RX, LLC FDA Rx Only

Irbesartan is an angiotensin II receptor (AT 1 subtype) antagonist. Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[ p -( o -1 H -tetrazol-5-ylphenyl) benzyl]-1,3-diazaspiro[4.4] non-1-en-4-one. Its empirical formula is C 25 H 28 N 6 O, and the structural formula: Irbesartan, USP is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Irbesartan Tablets, USP are available for oral administration as tablets containing 75 mg, 150 mg, or 300 mg of irbesartan. Inactive ingredients include: Carboxymethyl cellulose calcium, povidone, polysorbate 80, lactose monohydrate, microcrystalline cellulose, and magnesium stearate. "Image Description"

Isoniazid ISONIAZID
CHARTWELL RX, LLC FDA Rx Only

Isoniazid is an antibacterial available as a clear solution with peppermint flavor for oral administration. Each 5 mL (teaspoonful) of oral solution contains 50 mg of isoniazid, USP. This product also contains as inactive ingredients: flavoring (peppermint), glycerin, methylparaben and propylparaben. Isoniazid is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has a molecular formula of C 6 H 7 N 3 O and a molecular weight of 137.14. It has the following structural formula: 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. image description

Isoniazid ISONIAZID
CHARTWELL RX, LLC FDA Rx Only

Isoniazid, USP is an antibacterial available as 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: calcium sulfate dihydrate, pregelatinized starch, croscarmellose sodium, povidone, purified water, and calcium stearate. Isoniazid, USP is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has a molecular formula of C 6 H 7 N 3 O and a molecular weight of 137.14. It has the following structural formula: Isoniazid, USP 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, USP is slowly affected by exposure to air and light. Isoniazid Structure

Isosorbide Mononitrate ISOSORBIDE MONONITRATE
CHARTWELL RX, LLC FDA Rx Only

Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, ISMN 30 mg tablets, USP contains the following inactive ingredients: colloidal silicon dioxide, compressible sugar, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate. ISMN 60 mg tablets, USP contains the following inactive ingredients: colloidal silicon dioxide, compressible sugar, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, yellow iron oxide. ISMN 120 mg tablets, USP contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate and talc. The molecular formula of ISMN is C 6 H 9 NO 6 and the molecular weight is 191.14. The chemical name for ISMN is: 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula: ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane. Isosorbide Mononitrate Extended-Release 120 mg Tablets, USP meets USP Dissolution Test 7. FDA approved dissolution acceptance criteria for Isosorbide Mononitrate Extended-Release 30 mg and 60 mg Tablets, USP differ from that of the USP. Isosorbide-mononitrate-chemical-structure

Ketorolac Tromethamine KETOROLAC TROMETHAMINE
CHARTWELL RX, LLC FDA Rx Only

Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-Benzoyl-2,3-dihydro-1 H - pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol, and the structural formula is: C 15 H 13 NO 3 • C 4 H 11 NO 3 Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.41. Each tablet for oral administration contains 10 mg ketorolac tromethamine, USP. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. FDA approved dissolution specifications differ from USP. image description

Labetalol Hydrochloride LABETALOL HYDROCHLORIDE
CHARTWELL RX, LLC FDA Rx Only

Labetalol Hydrochloride Tablets, USP are adrenergic receptor blocking agents that have both selective alpha 1 -adrenergic and non-selective beta-adrenergic receptor blocking actions in a single substance. Labetalol HCl, USP is a racemate, chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] salicylamide monohydrochloride, and it has the following structural formula: Labetalol HCl, USP 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 HCl, USP is a white or off-white crystalline powder, soluble in water. Each tablet, for oral administration, contains 100 mg, 200 mg, or 300 mg of Labetalol Hydrochloride USP. In addition, each tablet contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, methocel, purified water, sodium starch glycolate and colorants (100 mg: Opadry yellow YS-1-12630; 200 mg: Opadry White YS-1-7003; 300 mg: Opadry Green YS-1-3256). labetalol-structure

Lacosamide Oral Solution LACOSAMIDE
CHARTWELL RX, LLC 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 is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol. "Image Description" 11.3 Lacosamide Oral Solution Lacosamide Oral Solution, USP contains 10 mg of lacosamide per mL. The inactive ingredients are purified water, sorbitol solution, glycerin, polyethylene glycol 4000, carboxymethylcellulose sodium, acesulfame potassium, methylparaben, cherry flavor, citric acid anhydrous and sodium chloride.

Lactulose LACTULOSE
CHARTWELL RX, LLC. FDA Rx Only

Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water. The pH range is 2.5 to 6.5. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C 12 H 22 O 11 . It has the following structural formula: The molecular weight is 342.30. It is freely soluble in water. The structural formula for lactulose.

Lactulose LACTULOSE
CHARTWELL RX, LLC FDA Rx Only

Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of Lactulose Solution, USP contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water. The pH range is 2.5 to 6.5. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose. The molecular formula is C 12 H 22 O 11 . It has the following structural formula: The molecular weight is 342.30. It is freely soluble in water. lactulose-oral-solution-structure

lamivudine LAMIVUDINE ORAL
CHARTWELL RX, LLC FDA Rx Only

Lamivudine (also known as 3TC) is a synthetic nucleoside analogue with activity against HIV-1 and HBV. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C 8 H 11 N 3 O 3 S and a molecular weight of 229.3 g per mol. It has the following structural formula: Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg per mL in water at 20°C. Lamivudine Oral Solution, USP is for oral administration. One milliliter (1 mL) of lamivudine oral solution, USP contains 10 mg of lamivudine (10 mg per mL) in an aqueous solution and the inactive ingredients alcohol (5% v/v), edetate disodium, artificial strawberry flavor, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), sucrose (200 mg) and purified water. image description

Leflunomide LEFLUNOMIDE
10 mg Tablet
CHARTWELL RX, LLC FDA Rx Only

Leflunomide Tablets, USP is a pyrimidine synthesis inhibitor. The chemical name for leflunomide is N-(4´-trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide. It has an empirical formula C 12 H 9 F 3 N 2 O 2 , a molecular weight of 270.2 and the following structural formula: Leflunomide is available for oral administration as tablets containing 10 or 20 mg of active drug. Combined with leflunomide are the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, pregelatinized starch, and talc. "Image Description"

LETROZOLE LETROZOLE
2.5 mg Tablet
CHARTWELL RX, LLC FDA Rx Only

Letrozole Tablets, USP for oral administration contain 2.5 mg of letrozole, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4'-(1H-1,2,4-Triazol-1-ylmethylene) dibenzonitrile, and its structural formula is Letrozole, USP is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31, empirical formula C 17H 11N5, and a melting range of 184°C to 185°C. Letrozole Tablets, USP are available as 2.5 mg tablets for oral administration. Inactive Ingredients: colloidal silica dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol/macrogol, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide, and the following color additives: yellow iron oxide, FD&C Yellow #5/Tartrazine Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake. letrozole-structure

LEVETIRACETAM solution LEVETIRACETAM
CHARTWELL RX, LLC FDA Rx Only

Levetiracetam Oral Solution, USP is an antiepileptic drug available as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8 H 14 N 2 O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) Levetiracetam Oral Solution contains 100 mg of levetiracetam per mL. Inactive ingredients: acesulfame potassium, citric acid, grape flavor, glycerin, methylparaben, propylparaben, purified water, sodium citrate, and sorbitol solution. "Image Description"

Levocetirizine Dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE
CHARTWELL RX, LLC FDA Rx Only

Levocetirizine dihydrochloride, the active component of Levocetirizine Dihydrochloride Oral Solution, is an orally active H 1 -receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C 21 H 25 ClN 2 O 3 •2HCl. The molecular weight is 461.82 and the chemical structure is shown below: Levocetirizine dihydrochloride is a white, crystalline powder and is water soluble. Levocetirizine dihydrochloride 0.5 mg/mL oral solution is formulated as an immediate release, clear, colorless liquid. Inactive ingredients are: sodium acetate trihydrate, glacial acetic acid, maltitol solution, glycerin, methylparaben, propylparaben, sucralose, artificial grape flavor, purified water. image description

Levofloxacin LEVOFLOXACIN
250 mg Tablet
CHARTWELL RX, LLC FDA Rx Only

Levofloxacin tablets, USP is a synthetic antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin The empirical formula is C 18 H 20 FN 3 O 4 •½ H 2 O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin, USP is essentially constant (approximately 100 mg/mL). Levofloxacin, USP is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin, USP has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al +3 >Cu +2 >Zn +2 >Mg +2 >Ca +2 . Levofloxacin tablets, USP are available as film-coated tablets and contain the following inactive ingredients: 250 mg (as expressed in the anhydrous form): corn starch, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, and titanium dioxide . 500 mg (as expressed in the anhydrous form): corn starch, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, and titanium dioxide. 750 mg (as expressed in the anhydrous form): corn starch, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, and titanium dioxide. Meets USP dissolution test 4. image description

Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE
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Lidocaine Hydrochloride Oral Topical Solution, USP, 2% (viscous) contains a local anesthetic agent and is administered topically. Lidocaine hydrochloride oral topical solution USP, 2% (viscous) contains lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)- N -(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula: The molecular formula of lidocaine is C 14 H 22 N 2 O. The molecular weight is 234.34. COMPOSITION OF SOLUTION Each mL contains 20 mg of lidocaine HCl, wild cherry flavor, methylparaben, propylparaben, saccharin sodium, sodium carboxymethylcellulose, and sodium hydroxide in purified water. The pH is adjusted to 5.0 to 7.0 with hydrochloric acid and/or sodium hydroxide. image description

linezolid LINEZOLID
600 mg Tablet
CHARTWELL RX, LLC FDA Rx Only

Linezolid Tablets contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The empirical formula is C 16 H 20 FN 3 O 4 . Its molecular weight is 337.35, and its chemical structure is represented below: Linezolid tablets for oral administration contain 600 mg linezolid as a film-coated tablet. Inactive ingredients are low-substituted hydroxypropyl cellulose, lactose monohydrate, sodium starch glycolate, hydroxypropyl cellulose, colloidal silicon dioxide, magnesium stearate, polyethylene glycol, titanium dioxide and hydroxypropyl methylcellulose. The sodium (Na+) content is 2.405 mg per 600-mg tablet (0.1mEq/tablet). Image linezolid structure

Lorazepam LORAZEPAM
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Lorazepam Tablets, USP, an antianxiety agent, has the chemical formula, 7-Chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-2 H -1,4-benzodiazepin-2-one: C 15 H 10 Cl 2 N 2 O 2 MW: 321.16 It is a white or almost white crystalline powder almost insoluble in water. Each Lorazepam Tablet, USP, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of Lorazepam, USP. The inactive ingredients present are croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and tribasic calcium phosphate. image description

Lorazepam LORAZEPAM
2 mg/ml
CHARTWELL RX, LLC FDA Rx Only

Lorazepam, an antianxiety agent, has the chemical formula, 2 H -1,4-benzodiazepin-2-one, 7-chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-, (±)-: C 15 H 10 Cl 2 N 2 O 2 MW: 321.16 Lorazepam, USP is a white or a practically white powder almost insoluble in water. Each mL of Lorazepam for oral administration contains 2 mg of lorazepam. The inactive ingredients present are polyethylene glycol and propylene glycol. image description

Loxapine LOXAPINE
6.8 mg
CHARTWELL RX, LLC FDA Rx Only

Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[ b,f ][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 or 13.6 mg equivalent to 5 or 10 mg of loxapine base respectively. It also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, gelatin, magnesium stearate, polacrilin potassium, sodium lauryl sulfate, talc, titanium dioxide, D&C Yellow #10 and FD&C Blue #1. Additionally, the 5 mg capsule contains D&C Red #33 and the 10 mg capsule contains D&C Red #33 and D&C Red #28. In addition, the black imprinting ink contains shellac glace in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue #2/indigo carmine aluminum lake, FD&C Red #40/Allurea Red AC aluminum lake, FD&C Blue #1/brilliant Blue FCF aluminum lake, D&C Yellow #10 aluminum lake, SDA 3A alcohol, and methanol. The white imprinting ink contains pharmaceutical glaze in SD-45, titanium dioxide, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol and simethicone. Loxapine Capsules, USP

Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE
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Meclizine Hydrochloride, USP, a histamine (H1) receptor antagonist, is a white or slightly yellowish crystalline powder. It has the following structural formula: Molecular Weight - 481.88 Chemically, meclizine hydrochloride is 1-( p -chloro-α-phenylbenzyl)-4-( m -methylbenzyl) piperazine dihydrochloride monohydrate. Tablets Inactive ingredients for the tablets are: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, stearic acid, talc and titanium dioxide. Meclizine hydrochloride tablets, USP are available in three strengths, 12.5 mg, 25 mg and 50 mg. Each meclizine hydrochloride, USP 12.5 mg tablet contains 12.5 mg of meclizine dihydrochloride equivalent to 10.53 mg of meclizine free base. Each meclizine hydrochloride, USP 25 mg tablet contains 25 mg of meclizine dihydrochloride equivalent to 21.07 mg of meclizine free base. Each meclizine hydrochloride, USP 50 mg tablet contains 50 mg of meclizine dihydrochloride equivalent to 42.14 mg of meclizine free base. "Image Description"

Mefloquine Hydrochloride MEFLOQUINE HYDROCHLORIDE
CHARTWELL RX, LLC FDA Rx Only

Mefloquine hydrochloride is an antimalarial agent available as 250 mg tablets of mefloquine hydrochloride (equivalent to 228.0 mg of the free base) for oral administration. Mefloquine hydrochloride is a 4-quinolinemethanol derivative with the specific chemical name of (R*, S*)-(±)-α-2-piperidinyl-2,8-bis (trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water. Mefloquine hydrochloride has a calculated molecular weight of 414.78 and the following structural formula: Mefloquine Hydrochloride Tablets USP, 250 mg meets USP Dissolution Test 2. The inactive ingredients are crospovidone, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. "Image Description"

memantine MEMANTINE
5 mg Tablet
CHARTWELL RX, LLC FDA Rx Only

Memantine hydrochloride, USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride, USP is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C 12 H 21 N•HCl and the molecular weight is 215.76. Memantine HCl, USP occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride, USP is available as tablets. Memantine hydrochloride, USP is available for oral administration as white to off-white capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride, USP. The tablets also contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate and croscarmellose sodium. In addition the following inactive ingredients are also present as components of the film coat: titanium dioxide, hypromellose, polyethylene glycol, and hydroxypropyl cellulose. image description

Memantine Hydrochloride MEMANTINE HYDROCHLORIDE
CHARTWELL RX, LLC FDA Rx Only

Memantine Hydrochloride, USP is an orally active NMDA receptor antagonist. The chemical name for Memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C 12 H 21 N•HCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride oral solution contains memantine hydrochloride in a strength equivalent to 2 mg of memantine hydrochloride in each mL. The oral solution also contains the following inactive ingredients: sucralose, methylparaben, propylparaben, propylene glycol, glycerin, peppermint flavor PFC 9927, citric acid, sodium citrate, and purified water. image description

Mesalamine MESALAMINE
1.2 g Delayed-release
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Each Mesalamine Delayed-Release Tablet, USP for oral administration contains 1.2 g 5-aminosalicylic acid (5-ASA; mesalamine), an anti-inflammatory agent. Mesalamine also has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: Molecular formula: C 7 H 7 NO 3 Molecular weight: 153.14 The tablet is coated with a pH-dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine then begins to be released from the tablet core. The tablet core contains mesalamine with hydrophilic and lipophilic excipients and provides for extended release of mesalamine. The inactive ingredients of Mesalamine Delayed-Release Tablets, USP are colloidal silicon dioxide, magnesium stearate, carboxymethylcellulose sodium, sodium starch glycolate, hypromellose, microcrystalline cellulose, methacrylic acid-methyl methacrylate copolymer 1:1, methacrylic acid-methyl methacrylate copolymer 1:2, triethyl citrate, talc, polyvinyl alcohol, titanium dioxide, macrogol/PEG, iron oxide red and iron oxide yellow. FDA approved dissolution test specifications differ from USP. image description

Methenamine Mandelate METHENAMINE MANDELATE
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Methenamine mandelate, a urinary antibacterial agent, is the chemical combination of mandelic acid with methenamine. Methenamine mandelate is available for oral use as film-coated tablets. Methenamine mandelate tablets contain 500 mg and 1000 mg (1 g) methenamine mandelate and the following inactive ingredients: croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc and titanium dioxide.

Methimazole METHIMAZOLE
CHARTWELL RX, LLC FDA Rx Only

Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4 H 6 N 2 S. The structural formula is as follows: image description

Methotrexate METHOTREXATE
2.5 mg Tablet
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Methotrexate is dihydrofolate reductase inhibitor with the chemical name of L-Glutamic acid, N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-,disodium salt (9CI). The molecular formula is C 20 H 22 N 8 O 5 Na 2 and the molecular weight is 498.40 g/mol. The structural formula is: Methotrexate Tablets, USP for oral use is available in bottles of 36 tablets. Each methotrexate tablet contains 2.5 mg methotrexate equivalent to 2.74 mg methotrexate disodium and the following inactive ingredients: lactose monohydrate, magnesium stearate and pregelatinized starch (maize). Chemical Structure

Methyldopa METHYLDOPA
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Methyldopa is an antihypertensive drug. Methyldopa, the L -isomer of alpha-methyldopa, is levo-3-(3,4-dihydroxyphenyl)-2-methylalanine. Its empirical formula is C 10 H 13 NO 4 , with a molecular weight of 211.22, and its structural formula is: Methyldopa is a white to yellowish white, odorless fine powder, and is soluble in water. Methyldopa Tablets, USP is supplied as tablets, for oral use, in two strengths: 250 mg and 500 mg of methyldopa per tablet. Inactive ingredients in the tablets are: lactose monohydrate, hypromellose , citric acid, corn starch, colloidal silicon dioxide, microcrystalline cellulose, ethyl cellulose, magnesium stearate, and polyethylene glycol. image description

Methylprednisolone METHYLPREDNISOLONE
CHARTWELL RX, LLC FDA Rx Only

Methylprednisolone Tablets, USP contain Methylprednisolone, USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone, USP occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for Methylprednisolone, USP is pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6α,11β)-and the molecular weight is 374.48. The structural formula is represented below: Each Methylprednisolone Tablets, USP for oral administration contains 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of Methylprednisolone, USP. In addition, each tablet contains the inactive ingredients colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. ACTIONS Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli. image description

metoclopramide hydrochloride METOCLOPRAMIDE HYDROCHLORIDE
CHARTWELL RX, LLC FDA Rx Only

Metoclopramide Oral Solution, USP is an orange color clear, palatable, aromatic, sugar-free liquid, with characteristic butterscotch flavor, for oral administration. Each 5 mL (teaspoonful) contains: Metoclopramide base (as the monohydrochloride monohydrate) 5 mg. Inactive Ingredients: Citric acid, sodium saccharin dihydrate, propylene glycol, methylparaben, propylparaben, FD&C Yellow #6, butterscotch flavor, and water. (pH of the product is between 2.0 and 5.5). Metoclopramide hydrochloride is a white, crystalline, odorless substance, freely soluble in water. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its molecular formula is C 14 H 22 ClN 3 O 2 •HCl•H 2 O, with a molecular weight of 354.3. Its structure formula is: image description

Metronidazole METRONIDAZOLE
CHARTWELL RX, LLC FDA Rx Only

Metronidazole Tablets, USP 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula: Metronidazole tablets, USP contain 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil and silicified microcrystalline cellulose. image description

Metronidazole METRONIDAZOLE
CHARTWELL RX, LLC FDA Rx Only

Metronidazole Capsules, USP 375 mg is an oral formulation of the synthetic nitroimidazole antimicrobial agent, 2-methyl-5-nitro-1 H -imidazole-1-ethanol, which has the following structural formula: Metronidazole Capsules, USP 375 mg contain 375 mg of Metronidazole, USP. Inactive ingredients include butyl alcohol, black iron oxide, corn starch, dehydrated alcohol, FD&C Blue No. 1, FD&C Red No.3, magnesium stearate, isopropyl alcohol, pregelatinized starch, propylene glycol, shellac, strong ammonia solution, potassium hydroxide and titanium dioxide. "Image Description"

MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE
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Mexiletine hydrochloride, USP is an orally active antiarrhythmic agent. It is a white to off-white crystalline powder with slightly bitter taste, freely soluble in water and in alcohol. Mexiletine hydrochloride, USP has a pKa of 9.2. The chemical name of mexiletine hydrochloride, USP is 1-methyl-2-(2,6-xylyloxy)ethylamine hydrochloride and its structural formula is: C 11 H 17 NO·HCl Mol. Wt. 215.72 Each capsule for oral administration, contains 250 mg of mexiletine hydrochloride, USP. 100 mg of mexiletine hydrochloride, USP is equivalent to 83.31 mg of mexiletine base. In addition, each capsule contains the following excipients: colloidal silicon dioxide, magnesium stearate and pregelatinized corn starch. The capsule shell contains: FD&C Yellow #6, gelatin, titanium dioxide, FD&C Blue #1 and D&C Yellow #10. The imprinting ink contains: ammonium hydroxide, black iron oxide, propylene glycol and shellac. image description

Minocycline Hydrochloride MINOCYCLINE HYDROCHLORIDE
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Minocycline Hydrochloride, USP a semisynthetic derivative of tetracycline, is 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is: C 23 H 27 N 3 O 7 •HCL M.W. 493.94 Minocycline Hydrochloride Tablets, USP for oral administration contain minocycline HCl equivalent to 50 mg, 75 mg or 100 mg of minocycline. In addition, 50 mg, 75 mg and 100 mg tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, titanium dioxide, hypromellose, polyethylene glycol 400, and polysorbate 80. "Image Description"

Moexipril Hydrochloride MOEXIPRIL HYDROCHLORIDE
CHARTWELL RX, LLC FDA Rx Only

Moexipril Hydrochloride, USP, the hydrochloride salt of moexipril, has the empirical formula C 27 H 34 N 2 O 7 •HCl and a molecular weight of 535.04. It is chemically described as [3S-[2[R*(R*)],3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-3-isoquinolinecarboxylic acid, monohydrochloride. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat and its structural formula is: Moexipril Hydrochloride, USP is a fine white to off-white powder. It is soluble (about 10% weight-to-volume) in distilled water at room temperature. Moexipril Hydrochloride Tablets, USP are supplied as scored, film-coated tablets containing 7.5 mg and 15 mg of moexipril hydrochloride for oral administration. In addition to the active ingredient, moexipril hydrochloride, the tablet core contains the following inactive ingredients: lactose monohydrate, crospovidone, magnesium oxide, povidone, colloidal silicon dioxide, and magnesium stearate. The film-coating contains hypromellose, polyethylene glycol, titanium dioxide, iron oxide red and iron oxide yellow. "Image Description"

Nabumetone NABUMETONE
CHARTWELL RX, LLC FDA Rx Only

Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure: Nabumetone Nabumetone is a white to off-white crystalline substance with a molecular weight of 228.3. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4. Tablets for Oral Administration Each oval-shaped, film-coated tablet contains 500 mg or 750 mg of nabumetone. Inactive ingredients consist of hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, and titanium dioxide. image description

Naltrexone Hydrochloride NALTREXONE HYDROCHLORIDE
CHARTWELL RX, LLC FDA Rx Only

Naltrexone Hydrochloride Tablets, USP an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethyl group. Naltrexone Hydrochloride, USP is also related to the potent opioid antagonist, naloxone, or n-allylnoroxymorphone. Naltrexone hydrochloride Naltrexone hydrochloride is a white or almost white powder. The hydrochloride salt is freely soluble in water. Naltrexone Hydrochloride Tablets, USP are available as film-coated tablets containing 50 mg of naltrexone hydrochloride. Naltrexone Hydrochloride Tablets, USP also contain: lactose monohydrate, hypromellose, magnesium stearate, polyethylene glycol, titanium dioxide, colloidal silicon dioxide, hydroxypropyl cellulose, yellow ferric oxide and red ferric oxide. Chemical Structure

Neomycin Sulfate NEOMYCIN SULFATE
CHARTWELL RX, LLC FDA Rx Only

Neomycin Sulfate Tablets, USP for oral administration, contain neomycin which is an antibiotic obtained from the metabolic products of the actinomycete Streptomyces fradiae . Structurally, Neomycin Sulfate, USP may be represented as follows: Chemically, it is O -2,6-diamino-2,6-dideoxy-α-D- glucopyranosyl-(1→3)- O -β-D-ribofuranosyl-(1→ 5)- O - [2,6-diamino-2,6-dideoxy -α-D- glucopyranosyl-(1→ 4)]-2-deoxy-D-streptamine. Neomycin B is identical except that the α -D- glucopyranosyl residue in the neobiosamine moiety is β-L-idopyranosyl. Each tablet contains 500 mg Neomycin Sulfate, USP (equivalent to 350 mg neomycin base). Inactive Ingredients: anhydrous lactose, calcium stearate, and povidone. image description

NIACIN NIACIN
500 mg Extended-release
CHARTWELL RX, LLC FDA Rx Only

Niacin Extended-release Tablets, USP (niacin tablet, film-coated extended-release), contain niacin, which at therapeutic doses is an antihyperlipidemic agent. Niacin (nicotinic acid, or 3-pyridinecarboxylic acid) is a white, crystalline powder, very soluble in water, with the following structural formula: Niacin extended-release tablets are unscored, red, film-coated tablets for oral administration and are available in two tablet strengths containing 500 and 1000 mg niacin. Niacin extended-release tablets also contain the inactive ingredients black iron oxide, colloidal silicon dioxide, hydroxypropyl cellulose, lecithin, polyethylene glycol, polyvinyl alcohol, red iron oxide, sodium stearyl fumarate, talc, titanium dioxide, and yellow iron oxide. USP Dissolution Test 5. structural formula

Nifedipine NIFEDIPINE
CHARTWELL RX, LLC FDA Rx Only

Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3, 5-pyridinedicarboxylic acid, 1, 4-dihydro-2, 6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, C 17 H 18 N 2 O 6 , and has the structural formula: Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.33. Nifedipine Extended-release Tablet, USP is formulated as a once-a-day extended-release tablet for oral administration designed to deliver 30, 60, or 90 mg of nifedipine. Inert ingredients in the formulations are: black iron oxide; cellulose acetate; colloidal silicon dioxide; hypromellose; lactose monohydrate; magnesium stearate; microcrystalline cellulose; polyethylene glycol; polyethylene oxide; polysorbate; povidone; propylene glycol; red ferric oxide; sodium chloride; titanium dioxide; triacetin. System Components and Performance Nifedipine Extended-release Tablet is similar in appearance to a conventional tablet. It consists, however, of a semipermeable membrane surrounding an osmotically active drug core. As water from the gastrointestinal tract enters the tablet, pressure increases in the core of the tablet, releasing drug through the precision laser-drilled tablet orifice in the one side of the tablet. Nifedipine Extended-release Tablet is designed to provide nifedipine at an approximately constant rate over 24 hours. This controlled rate of drug delivery into the gastrointestinal lumen is independent of pH or gastrointestinal motility. Nifedipine Extended-release Tablet depends for its action on the existence of an osmotic gradient between the contents of the tablet core and fluid in the GI tract. Drug delivery is essentially constant as long as the osmotic gradient remains constant, and then gradually falls to zero. Upon swallowing, the biologically inert components of the tablet remain intact during GI transit and are eliminated in the feces as an insoluble shell. USP Drug Release Test 5. image description

Nifedipine NIFEDIPINE
CHARTWELL RX, LLC FDA Rx Only

Nifedipine, USP is an antianginal drug belonging to a class of pharmacological agents, the calcium channel blockers. Nifedipine is 1, 4-Dihydro-2, 6-dimethyl-4-(2-nitrophenyl)-3, 5-pyridinecarboxylic acid dimethyl ester, C 17 H 18 N 2 O 6 , and has the structural formula: Nifedipine, USP is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine capsules, USP are formulated as soft gelatin capsules for oral administration, each containing 10 mg or 20 mg nifedipine, USP. Inactive Ingredients: Nifedipine capsules, USP for oral administration contain the following inactive ingredients: glycerin, peppermint oil, polyethylene glycol and saccharin sodium. The 10 mg capsule shell contains ammonium hydroxide, gelatin, glycerin, iron oxide black, light mineral oil, methyl paraben, propylene glycol, propyl paraben, shellac glaze, sorbitol, titanium dioxide and water. The 20 mg capsule shell contains ammonium hydroxide, FD and C Red No. 40 aluminum lake, FD and C Yellow No. 6 aluminum lake, gelatin, glycerin, iron oxide black, light mineral oil, methyl paraben, propylene glycol, propyl paraben, shellac glaze, sorbitol, titanium dioxide and water. image description

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