{
"NDC": [
{
"NDCCode": "62332-635-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (62332-635-60) ",
"NDC11Code": "62332-0635-60",
"ProductNDC": "62332-635",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran Etexilate",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240813",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215233",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "110",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240813",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4) For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is off-white to yellowish powder. It is freely soluble in methanol and ethanol, practically insoluble in acetone, ethyl acetate and water. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: hydroxypropyl cellulose, hypromellose phthalate, pelletized tartaric acid, talc. The capsule shell is composed of carrageenan, hypromellose, potassium chloride and titanium dioxide. Additionally, 110 mg and 150 mg capsule shell also contains FD&C Blue No. 2. The empty hard hypromellose capsule shells are printed with edible black ink containing iron oxide black, potassium hydroxide and shellac."
},
{
"NDCCode": "62332-635-06",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (62332-635-06) / 6 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "62332-0635-06",
"ProductNDC": "62332-635",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran Etexilate",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240813",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215233",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "110",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240813",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4) For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is off-white to yellowish powder. It is freely soluble in methanol and ethanol, practically insoluble in acetone, ethyl acetate and water. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: hydroxypropyl cellulose, hypromellose phthalate, pelletized tartaric acid, talc. The capsule shell is composed of carrageenan, hypromellose, potassium chloride and titanium dioxide. Additionally, 110 mg and 150 mg capsule shell also contains FD&C Blue No. 2. The empty hard hypromellose capsule shells are printed with edible black ink containing iron oxide black, potassium hydroxide and shellac."
},
{
"NDCCode": "10237-635-60",
"PackageDescription": "1 TUBE in 1 CARTON (10237-635-60) > 170 g in 1 TUBE",
"NDC11Code": "10237-0635-60",
"ProductNDC": "10237-635",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aim Tartar Control",
"ProprietaryNameSuffix": "Plus Mouthwash And Whitening",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20040301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "2.4",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-10-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "13668-635-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (13668-635-60) ",
"NDC11Code": "13668-0635-60",
"ProductNDC": "13668-635",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250716",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213604",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "49; 51",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250716",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan contain anionic forms of sacubitril and valsartan, sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, Sacubitril and valsartan dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The Sacubitril and valsartan is chemically described as Trisodium (4-{[(1S,3R)-1-([1,1'-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[(2'-(1H-tetrazol-1-id-5-yl)[1,1'-biphenyl]-4-yl]methyl}-L-valinate). Its empirical formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are crospovidone, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide and talc. The film-coat inactive ingredients are hypromellose, macrogol/PEG, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet contains iron oxide black and iron oxide red."
},
{
"NDCCode": "16590-635-60",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (16590-635-60)",
"NDC11Code": "16590-0635-60",
"ProductNDC": "16590-635",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"ProprietaryNameSuffix": "Delayed Release",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020987",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Pantoprazole sodium delayed-release tablets are indicated for.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole sodium has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n‑hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each pantoprazole sodium delayed-release tablet contains 45.1 mg or 22.56 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole sodium, respectively) with the following inactive ingredients: calcium stearate, crospovidone, hypromellose, iron oxide, mannitol, methacrylic acid copolymer, polysorbate 80, povidone, propylene glycol, sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrate. Pantoprazole sodium delayed-release tablets (40 mg and 20 mg) complies with USP dissolution test 2."
},
{
"NDCCode": "21695-635-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (21695-635-60)",
"NDC11Code": "21695-0635-60",
"ProductNDC": "21695-635",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin Slocaps",
"NonProprietaryName": "Nitroglycerin Sustained-release Capsules",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19820825",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Nitroglycerin Slocaps® (Nitroglycerin) are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each NITROGLYCERIN SLOCAP®, for oral administration, contains 2.5 mg, 6.5 mg, or 9 mg of nitroglycerin. Each capsule also contains the following inactive ingredients: gelatin, lactose, pharmaceutical glaze, corn starch, sucrose, talc and other ingredients. In addition, the 2.5 mg capsule contains FD&C Blue #1, FD&C Red #3 and D&C Yellow #10; the 6.5 mg capsule contains FD&C Blue #1, D&C Red #33, FD&C Yellow #6, and D&C Yellow #10; and the 9 mg capsule contains FD&C Green #3, FD&C Yellow #6, D&C Yellow #10 and titanium dioxide."
},
{
"NDCCode": "42783-663-60",
"PackageDescription": "1 KIT in 1 KIT (42783-663-60) * 60 TABLET, FILM COATED in 1 BOTTLE (42783-601-60) * 104 mL in 1 TUBE (42783-635-04)",
"NDC11Code": "42783-0663-60",
"ProductNDC": "42783-663",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzodox 60 Kit",
"NonProprietaryName": "Doxycycline Tablets And Advanced Acne Wash",
"DosageFormName": "KIT",
"StartMarketingDate": "20150922",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Elorac, Inc.",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Doxycycline tablets, USP is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline 100 mg tablets contain doxycycline monohydrate equivalent to 100 mg of doxycycline for oral administration. Inactive ingredients include anhydrous lactose, microcrystalline cellulose, corn starch, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, D&C yellow #10 aluminum lake, and FD&C yellow #6 aluminum lake. The chemical designation of the light-yellow crystalline powder is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. Structural formula. Doxycycline tablets, USP has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form."
},
{
"NDCCode": "43353-635-60",
"PackageDescription": "90 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (43353-635-60)",
"NDC11Code": "43353-0635-60",
"ProductNDC": "43353-635",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrochlorothiazide",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20020917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075907",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Hydrochlorothiazide Capsules USP are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors.",
"Description": "Hydrochlorothiazide Capsules USP 12.5 mg is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2; its molecular weight is 297.74; and its structural formula is. It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Hydrochlorothiazide is supplied as 12.5 mg capsules for oral use. Each capsule contains the following inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium benzoate. Gelatin capsules contain D&C Red #28, D&C Yellow #10, FD&C Blue #1, gelatin and titanium dioxide."
},
{
"NDCCode": "45963-635-01",
"PackageDescription": "60 TABLET in 1 BOTTLE (45963-635-01) ",
"NDC11Code": "45963-0635-01",
"ProductNDC": "45963-635",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lovastatin",
"NonProprietaryName": "Lovastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20011217",
"EndMarketingDate": "20210331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075828",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "LOVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110926",
"EndMarketingDatePackage": "20210228",
"SamplePackage": "N"
},
{
"NDCCode": "46708-635-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (46708-635-60) ",
"NDC11Code": "46708-0635-60",
"ProductNDC": "46708-635",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran Etexilate",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240813",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215233",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "110",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240813",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4) For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is off-white to yellowish powder. It is freely soluble in methanol and ethanol, practically insoluble in acetone, ethyl acetate and water. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: hydroxypropyl cellulose, hypromellose phthalate, pelletized tartaric acid, talc. The capsule shell is composed of carrageenan, hypromellose, potassium chloride and titanium dioxide. Additionally, 110 mg and 150 mg capsule shell also contains FD&C Blue No. 2. The empty hard hypromellose capsule shells are printed with edible black ink containing iron oxide black, potassium hydroxide and shellac."
},
{
"NDCCode": "50742-635-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-635-60) ",
"NDC11Code": "50742-0635-60",
"ProductNDC": "50742-635",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208947",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170831",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine extended-release tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (light yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients: The following are common in all 5 tablet strengths: microcrystalline cellulose, hypromellose, magnesium stearate, povidone, polyethylene glycol, and titanium dioxide. Additional inactive ingredients include: 50 mg - polyvinyl alcohol, talc, iron oxide yellow, iron oxide red, iron oxide black, lecithin (soya);150 mg - polydextrose and triacetin; 200 mg - polyvinyl alcohol, talc, lecithin (soya), D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake and FD&C blue #2 aluminum lake; 300 mg - polyvinyl alcohol, talc, lecithin (soya), iron oxide yellow and iron oxide black; 400 mg - polydextrose, and triacetin. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. Meets USP dissolution test 6."
},
{
"NDCCode": "58411-635-60",
"PackageDescription": "1 TUBE in 1 CARTON (58411-635-60) / 21 mL in 1 TUBE",
"NDC11Code": "58411-0635-60",
"ProductNDC": "58411-635",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cle De Peau Beaute Radiant Foundation N",
"ProprietaryNameSuffix": "B40",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "SHISEIDO AMERICAS CORPORATION",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "1.07; .3",
"StrengthUnit": "g/21mL; g/21mL",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210501",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "61919-635-60",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-635-60)",
"NDC11Code": "61919-0635-60",
"ProductNDC": "61919-635",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090901",
"LabelerName": "DIRECT RX",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Pantoprazole Sodium Delayed-Release Tablets are indicated for. 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD). Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. 1.2 Maintenance of Healing of Erosive Esophagitis. Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months. 1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome. Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.",
"Description": "The active ingredient in pantoprazole sodium delayed-release tablets USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole is supplied as delayed-release tablets, available in two strengths (20 mg and 40 mg). Each pantoprazole sodium delayed-release tablet USP contains 45.1 mg or 22.56 mg of pantoprazole sodium sesquihydrate USP (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium stearate USNF, ferric oxide red USNF, ferric oxide black, hypromellose USP, hypromellose phthalate USNF, mannitol USP, methacrylic acid copolymer USNF, polyethylene glycol USNF, silicon dioxide USNF, sodium carbonate USNF, sucrose USNF, talc USP, titanium dioxide USP, triethyl citrate USNF. In addition to the above, printing ink used to imprint the tablet contains ammonium hydroxide USNF, ferric oxide black, propylene glycol USP, and shellac USNF. Pantoprazole Sodium Delayed-Release Tablets USP (40 mg and 20 mg) comply with USP dissolution test 4."
},
{
"NDCCode": "63187-635-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (63187-635-60) ",
"NDC11Code": "63187-0635-60",
"ProductNDC": "63187-635",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20031201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021210",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": ".175",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160201",
"SamplePackage": "N",
"IndicationAndUsage": "Levothyroxine sodium is used for the following indications. Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS), including thyroid nodules (see WARNINGS and PRECAUTIONS), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.",
"Description": "Levothyroxine Sodium Tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown."
},
{
"NDCCode": "66336-635-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (66336-635-60)",
"NDC11Code": "66336-0635-60",
"ProductNDC": "66336-635",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carisoprodol",
"NonProprietaryName": "Carisoprodol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040245",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "CARISOPRODOL",
"StrengthNumber": "350",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carisoprodol Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)].",
"Description": "Carisoprodol Tablets, USP are available as 350 mg round, white tablets for oral administration. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other ingredients in Carisoprodol Tablets, USP include croscarmellose sodium, hydrogenated vegetable oil, hypromellose, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "71205-635-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (71205-635-60) ",
"NDC11Code": "71205-0635-60",
"ProductNDC": "71205-635",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinapril",
"NonProprietaryName": "Quinapril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077690",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "QUINAPRIL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220131",
"SamplePackage": "N",
"IndicationAndUsage": "Quinapril tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril tablets USP. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Quinapril tablets USP may be used alone or in combination with thiazide diuretics. Heart Failure. Quinapril tablets USP is indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril tablets USP, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril tablets USP does not have a similar risk (see WARNINGS).",
"Description": "Quinapril hydrochloride is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1- (ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3- isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 HCl and its structural formula is. Quinapril hydrochloride is a white to off-white amorphous powder that is freely soluble in aqueous solvents. Quinapril tablets USP contain 5 mg, (equivalent to 5.416 mg Quinapril Hydrochloride), 10 mg (equivalent to 10.832 mg Quinapril Hydrochloride), 20 mg (equivalent to 21.664 mg Quinapril Hydrochloride), or 40 mg (equivalent to 43.328 mg Quinapril Hydrochloride) of quinapril for oral administration. Each film-coated tablet also contains crospovidone, iron oxide yellow, lecithin, magnesium carbonate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, povidone, talc, titanium dioxide and xanthan gum."
},
{
"NDCCode": "71610-635-53",
"PackageDescription": "60 TABLET in 1 BOTTLE (71610-635-53) ",
"NDC11Code": "71610-0635-53",
"ProductNDC": "71610-635",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076796",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2022-03-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220222",
"SamplePackage": "N",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide Tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: corn starch NF, lactose monohydrate NF, magnesium stearate NF, pregelatinized starch NF, and talc USP. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is available as white-off white tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Tested by USP Dissolution Test 1."
},
{
"NDCCode": "71610-635-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (71610-635-60) ",
"NDC11Code": "71610-0635-60",
"ProductNDC": "71610-635",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076796",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2022-03-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220222",
"SamplePackage": "N",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide Tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: corn starch NF, lactose monohydrate NF, magnesium stearate NF, pregelatinized starch NF, and talc USP. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is available as white-off white tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Tested by USP Dissolution Test 1."
},
{
"NDCCode": "62332-001-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (62332-001-60) ",
"NDC11Code": "62332-0001-60",
"ProductNDC": "62332-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078916",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160129",
"SamplePackage": "N"
},
{
"NDCCode": "62332-002-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (62332-002-60) ",
"NDC11Code": "62332-0002-60",
"ProductNDC": "62332-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078916",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160129",
"SamplePackage": "N"
},
{
"NDCCode": "62332-039-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (62332-039-60) ",
"NDC11Code": "62332-0039-60",
"ProductNDC": "62332-039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090607",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180205",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine is indicated for. Epilepsy - adjunctive therapy in patients aged 2 years and older: : 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures. , 3 generalized seizures of Lennox-Gastaut syndrome.(1.1) .",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as -triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine Tablets USP are supplied for oral administration as 25-mg, 100-mg, 150-mg and 200-mg white to off white tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose monohydrate, magnesium stearate, povidone, sodium starch glycolate and talc.It meets USP Dissolution Test 3."
},
{
"NDCCode": "62332-040-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (62332-040-60) ",
"NDC11Code": "62332-0040-60",
"ProductNDC": "62332-040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090607",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180205",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine is indicated for. Epilepsy - adjunctive therapy in patients aged 2 years and older: : 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures. , 3 generalized seizures of Lennox-Gastaut syndrome.(1.1) .",
"Description": "Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as -triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine Tablets USP are supplied for oral administration as 25-mg, 100-mg, 150-mg and 200-mg white to off white tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose monohydrate, magnesium stearate, povidone, sodium starch glycolate and talc.It meets USP Dissolution Test 3."
},
{
"NDCCode": "62332-061-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (62332-061-60) ",
"NDC11Code": "62332-0061-60",
"ProductNDC": "62332-061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leflunomide",
"NonProprietaryName": "Leflunomide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091369",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "LEFLUNOMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antirheumatic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161201",
"SamplePackage": "N",
"IndicationAndUsage": "Leflunomide tablets USP are indicated for the treatment of adults with active rheumatoid arthritis (RA).",
"Description": "Leflunomide USP is a pyrimidine synthesis inhibitor. The chemical name for leflunomide is N-(4´-trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide. It has an empirical formula C12H9F3N2O2, a molecular weight of 270.2 and the following structural formula. Leflunomide tablets USP are available for oral administration as tablets containing 10 mg or 20 mg of active drug. Combined with leflunomide are the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, iron oxide yellow (20 mg tablet only), lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, and titanium dioxide."
},
{
"NDCCode": "62332-062-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (62332-062-60) ",
"NDC11Code": "62332-0062-60",
"ProductNDC": "62332-062",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leflunomide",
"NonProprietaryName": "Leflunomide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091369",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "LEFLUNOMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antirheumatic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161201",
"SamplePackage": "N",
"IndicationAndUsage": "Leflunomide tablets USP are indicated for the treatment of adults with active rheumatoid arthritis (RA).",
"Description": "Leflunomide USP is a pyrimidine synthesis inhibitor. The chemical name for leflunomide is N-(4´-trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide. It has an empirical formula C12H9F3N2O2, a molecular weight of 270.2 and the following structural formula. Leflunomide tablets USP are available for oral administration as tablets containing 10 mg or 20 mg of active drug. Combined with leflunomide are the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, iron oxide yellow (20 mg tablet only), lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, and titanium dioxide."
},
{
"NDCCode": "62332-063-60",
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"ProductNDC": "62332-063",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Tartrate",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091689",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20220612",
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"IndicationAndUsage": "Rivastigmine tartrate capsules are an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild-to-moderate dementia of the Alzheimer’s type (AD) (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD) (1.2).",
"Description": "Rivastigmine tartrate is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt – hta salt) and a molecular weight of 400.43 g/mol (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3. Rivastigmine Tartrate Capsules USP contain rivastigmine tartrate , equivalent to 1.5 mg, 3 mg, 4.5 mg and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides."
},
{
"NDCCode": "62332-064-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (62332-064-60) ",
"NDC11Code": "62332-0064-60",
"ProductNDC": "62332-064",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Tartrate",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091689",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220612",
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"IndicationAndUsage": "Rivastigmine tartrate capsules are an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild-to-moderate dementia of the Alzheimer’s type (AD) (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD) (1.2).",
"Description": "Rivastigmine tartrate is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt – hta salt) and a molecular weight of 400.43 g/mol (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3. Rivastigmine Tartrate Capsules USP contain rivastigmine tartrate , equivalent to 1.5 mg, 3 mg, 4.5 mg and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides."
},
{
"NDCCode": "62332-065-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (62332-065-60) ",
"NDC11Code": "62332-0065-60",
"ProductNDC": "62332-065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Tartrate",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091689",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "4.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-06-14",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
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"IndicationAndUsage": "Rivastigmine tartrate capsules are an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild-to-moderate dementia of the Alzheimer’s type (AD) (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD) (1.2).",
"Description": "Rivastigmine tartrate is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt – hta salt) and a molecular weight of 400.43 g/mol (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3. Rivastigmine Tartrate Capsules USP contain rivastigmine tartrate , equivalent to 1.5 mg, 3 mg, 4.5 mg and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides."
},
{
"NDCCode": "62332-066-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (62332-066-60) ",
"NDC11Code": "62332-0066-60",
"ProductNDC": "62332-066",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine Tartrate",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091689",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
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"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine tartrate capsules are an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild-to-moderate dementia of the Alzheimer’s type (AD) (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD) (1.2).",
"Description": "Rivastigmine tartrate is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt – hta salt) and a molecular weight of 400.43 g/mol (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3. Rivastigmine Tartrate Capsules USP contain rivastigmine tartrate , equivalent to 1.5 mg, 3 mg, 4.5 mg and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides."
},
{
"NDCCode": "62332-075-60",
"PackageDescription": "60 TABLET, COATED in 1 BOTTLE (62332-075-60) ",
"NDC11Code": "62332-0075-60",
"ProductNDC": "62332-075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200891",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2021-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20151013",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride is indiacted for the treatment of moderate to severe dementia of the Alzheimer's type.",
"Description": "Memantine hydrochloride 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 C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in methanol and sparingly soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, macrogol/polyethylene glycol 400, FD&C yellow #6 aluminum lake and FD&C blue #2 aluminum lake (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets)."
},
{
"NDCCode": "62332-076-60",
"PackageDescription": "60 TABLET, COATED in 1 BOTTLE (62332-076-60) ",
"NDC11Code": "62332-0076-60",
"ProductNDC": "62332-076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200891",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2021-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151013",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride is indiacted for the treatment of moderate to severe dementia of the Alzheimer's type.",
"Description": "Memantine hydrochloride 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 C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in methanol and sparingly soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, macrogol/polyethylene glycol 400, FD&C yellow #6 aluminum lake and FD&C blue #2 aluminum lake (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets)."
}
]
}
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<NDCList>
<NDC>
<NDCCode>62332-635-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (62332-635-60) </PackageDescription>
<NDC11Code>62332-0635-60</NDC11Code>
<ProductNDC>62332-635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dabigatran Etexilate</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240813</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215233</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>110</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240813</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4) For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is off-white to yellowish powder. It is freely soluble in methanol and ethanol, practically insoluble in acetone, ethyl acetate and water. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: hydroxypropyl cellulose, hypromellose phthalate, pelletized tartaric acid, talc. The capsule shell is composed of carrageenan, hypromellose, potassium chloride and titanium dioxide. Additionally, 110 mg and 150 mg capsule shell also contains FD&C Blue No. 2. The empty hard hypromellose capsule shells are printed with edible black ink containing iron oxide black, potassium hydroxide and shellac.</Description>
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<NDC>
<NDCCode>62332-635-06</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (62332-635-06) / 6 CAPSULE in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>62332-635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dabigatran Etexilate</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240813</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215233</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>110</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240813</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4) For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is off-white to yellowish powder. It is freely soluble in methanol and ethanol, practically insoluble in acetone, ethyl acetate and water. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: hydroxypropyl cellulose, hypromellose phthalate, pelletized tartaric acid, talc. The capsule shell is composed of carrageenan, hypromellose, potassium chloride and titanium dioxide. Additionally, 110 mg and 150 mg capsule shell also contains FD&C Blue No. 2. The empty hard hypromellose capsule shells are printed with edible black ink containing iron oxide black, potassium hydroxide and shellac.</Description>
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<NDCCode>10237-635-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10237-635-60) > 170 g in 1 TUBE</PackageDescription>
<NDC11Code>10237-0635-60</NDC11Code>
<ProductNDC>10237-635</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aim Tartar Control</ProprietaryName>
<ProprietaryNameSuffix>Plus Mouthwash And Whitening</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20040301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13668-635-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (13668-635-60) </PackageDescription>
<NDC11Code>13668-0635-60</NDC11Code>
<ProductNDC>13668-635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250716</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213604</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>49; 51</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250716</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan contain anionic forms of sacubitril and valsartan, sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, Sacubitril and valsartan dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The Sacubitril and valsartan is chemically described as Trisodium (4-{[(1S,3R)-1-([1,1'-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[(2'-(1H-tetrazol-1-id-5-yl)[1,1'-biphenyl]-4-yl]methyl}-L-valinate). Its empirical formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are crospovidone, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide and talc. The film-coat inactive ingredients are hypromellose, macrogol/PEG, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet contains iron oxide black and iron oxide red.</Description>
</NDC>
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<NDCCode>16590-635-60</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (16590-635-60)</PackageDescription>
<NDC11Code>16590-0635-60</NDC11Code>
<ProductNDC>16590-635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<ProprietaryNameSuffix>Delayed Release</ProprietaryNameSuffix>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020987</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole sodium has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n‑hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each pantoprazole sodium delayed-release tablet contains 45.1 mg or 22.56 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole sodium, respectively) with the following inactive ingredients: calcium stearate, crospovidone, hypromellose, iron oxide, mannitol, methacrylic acid copolymer, polysorbate 80, povidone, propylene glycol, sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrate. Pantoprazole sodium delayed-release tablets (40 mg and 20 mg) complies with USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>21695-635-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (21695-635-60)</PackageDescription>
<NDC11Code>21695-0635-60</NDC11Code>
<ProductNDC>21695-635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin Slocaps</ProprietaryName>
<NonProprietaryName>Nitroglycerin Sustained-release Capsules</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19820825</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Nitroglycerin Slocaps® (Nitroglycerin) are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Each NITROGLYCERIN SLOCAP®, for oral administration, contains 2.5 mg, 6.5 mg, or 9 mg of nitroglycerin. Each capsule also contains the following inactive ingredients: gelatin, lactose, pharmaceutical glaze, corn starch, sucrose, talc and other ingredients. In addition, the 2.5 mg capsule contains FD&C Blue #1, FD&C Red #3 and D&C Yellow #10; the 6.5 mg capsule contains FD&C Blue #1, D&C Red #33, FD&C Yellow #6, and D&C Yellow #10; and the 9 mg capsule contains FD&C Green #3, FD&C Yellow #6, D&C Yellow #10 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42783-663-60</NDCCode>
<PackageDescription>1 KIT in 1 KIT (42783-663-60) * 60 TABLET, FILM COATED in 1 BOTTLE (42783-601-60) * 104 mL in 1 TUBE (42783-635-04)</PackageDescription>
<NDC11Code>42783-0663-60</NDC11Code>
<ProductNDC>42783-663</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzodox 60 Kit</ProprietaryName>
<NonProprietaryName>Doxycycline Tablets And Advanced Acne Wash</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150922</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Elorac, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Doxycycline tablets, USP is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline 100 mg tablets contain doxycycline monohydrate equivalent to 100 mg of doxycycline for oral administration. Inactive ingredients include anhydrous lactose, microcrystalline cellulose, corn starch, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, D&C yellow #10 aluminum lake, and FD&C yellow #6 aluminum lake. The chemical designation of the light-yellow crystalline powder is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. Structural formula. Doxycycline tablets, USP has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form.</Description>
</NDC>
<NDC>
<NDCCode>43353-635-60</NDCCode>
<PackageDescription>90 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (43353-635-60)</PackageDescription>
<NDC11Code>43353-0635-60</NDC11Code>
<ProductNDC>43353-635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075907</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrochlorothiazide Capsules USP are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors.</IndicationAndUsage>
<Description>Hydrochlorothiazide Capsules USP 12.5 mg is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2; its molecular weight is 297.74; and its structural formula is. It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Hydrochlorothiazide is supplied as 12.5 mg capsules for oral use. Each capsule contains the following inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium benzoate. Gelatin capsules contain D&C Red #28, D&C Yellow #10, FD&C Blue #1, gelatin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>45963-635-01</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (45963-635-01) </PackageDescription>
<NDC11Code>45963-0635-01</NDC11Code>
<ProductNDC>45963-635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lovastatin</ProprietaryName>
<NonProprietaryName>Lovastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20011217</StartMarketingDate>
<EndMarketingDate>20210331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075828</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>LOVASTATIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110926</StartMarketingDatePackage>
<EndMarketingDatePackage>20210228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>46708-635-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (46708-635-60) </PackageDescription>
<NDC11Code>46708-0635-60</NDC11Code>
<ProductNDC>46708-635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dabigatran Etexilate</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240813</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215233</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>110</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240813</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4) For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is off-white to yellowish powder. It is freely soluble in methanol and ethanol, practically insoluble in acetone, ethyl acetate and water. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: hydroxypropyl cellulose, hypromellose phthalate, pelletized tartaric acid, talc. The capsule shell is composed of carrageenan, hypromellose, potassium chloride and titanium dioxide. Additionally, 110 mg and 150 mg capsule shell also contains FD&C Blue No. 2. The empty hard hypromellose capsule shells are printed with edible black ink containing iron oxide black, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>50742-635-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-635-60) </PackageDescription>
<NDC11Code>50742-0635-60</NDC11Code>
<ProductNDC>50742-635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208947</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine extended-release tablet is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia (1.1), 2 Bipolar I disorder, manic, or mixed episodes (1.2), 3 Bipolar disorder, depressive episodes (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants (1.3).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is. Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (light yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients: The following are common in all 5 tablet strengths: microcrystalline cellulose, hypromellose, magnesium stearate, povidone, polyethylene glycol, and titanium dioxide. Additional inactive ingredients include: 50 mg - polyvinyl alcohol, talc, iron oxide yellow, iron oxide red, iron oxide black, lecithin (soya);150 mg - polydextrose and triacetin; 200 mg - polyvinyl alcohol, talc, lecithin (soya), D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake and FD&C blue #2 aluminum lake; 300 mg - polyvinyl alcohol, talc, lecithin (soya), iron oxide yellow and iron oxide black; 400 mg - polydextrose, and triacetin. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. Meets USP dissolution test 6.</Description>
</NDC>
<NDC>
<NDCCode>58411-635-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (58411-635-60) / 21 mL in 1 TUBE</PackageDescription>
<NDC11Code>58411-0635-60</NDC11Code>
<ProductNDC>58411-635</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cle De Peau Beaute Radiant Foundation N</ProprietaryName>
<ProprietaryNameSuffix>B40</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>SHISEIDO AMERICAS CORPORATION</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>1.07; .3</StrengthNumber>
<StrengthUnit>g/21mL; g/21mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61919-635-60</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-635-60)</PackageDescription>
<NDC11Code>61919-0635-60</NDC11Code>
<ProductNDC>61919-635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090901</ApplicationNumber>
<LabelerName>DIRECT RX</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Pantoprazole Sodium Delayed-Release Tablets are indicated for. 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD). Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. 1.2 Maintenance of Healing of Erosive Esophagitis. Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months. 1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome. Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium delayed-release tablets USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is. Pantoprazole sodium sesquihydrate USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole is supplied as delayed-release tablets, available in two strengths (20 mg and 40 mg). Each pantoprazole sodium delayed-release tablet USP contains 45.1 mg or 22.56 mg of pantoprazole sodium sesquihydrate USP (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium stearate USNF, ferric oxide red USNF, ferric oxide black, hypromellose USP, hypromellose phthalate USNF, mannitol USP, methacrylic acid copolymer USNF, polyethylene glycol USNF, silicon dioxide USNF, sodium carbonate USNF, sucrose USNF, talc USP, titanium dioxide USP, triethyl citrate USNF. In addition to the above, printing ink used to imprint the tablet contains ammonium hydroxide USNF, ferric oxide black, propylene glycol USP, and shellac USNF. Pantoprazole Sodium Delayed-Release Tablets USP (40 mg and 20 mg) comply with USP dissolution test 4.</Description>
</NDC>
<NDC>
<NDCCode>63187-635-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (63187-635-60) </PackageDescription>
<NDC11Code>63187-0635-60</NDC11Code>
<ProductNDC>63187-635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021210</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>.175</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levothyroxine sodium is used for the following indications. Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS), including thyroid nodules (see WARNINGS and PRECAUTIONS), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.</IndicationAndUsage>
<Description>Levothyroxine Sodium Tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown.</Description>
</NDC>
<NDC>
<NDCCode>66336-635-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (66336-635-60)</PackageDescription>
<NDC11Code>66336-0635-60</NDC11Code>
<ProductNDC>66336-635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carisoprodol</ProprietaryName>
<NonProprietaryName>Carisoprodol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040245</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>CARISOPRODOL</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carisoprodol Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Carisoprodol Tablets, USP are available as 350 mg round, white tablets for oral administration. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is. Other ingredients in Carisoprodol Tablets, USP include croscarmellose sodium, hydrogenated vegetable oil, hypromellose, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>71205-635-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71205-635-60) </PackageDescription>
<NDC11Code>71205-0635-60</NDC11Code>
<ProductNDC>71205-635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quinapril</ProprietaryName>
<NonProprietaryName>Quinapril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077690</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>QUINAPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quinapril tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril tablets USP. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Quinapril tablets USP may be used alone or in combination with thiazide diuretics. Heart Failure. Quinapril tablets USP is indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril tablets USP, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril tablets USP does not have a similar risk (see WARNINGS).</IndicationAndUsage>
<Description>Quinapril hydrochloride is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1- (ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3- isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 HCl and its structural formula is. Quinapril hydrochloride is a white to off-white amorphous powder that is freely soluble in aqueous solvents. Quinapril tablets USP contain 5 mg, (equivalent to 5.416 mg Quinapril Hydrochloride), 10 mg (equivalent to 10.832 mg Quinapril Hydrochloride), 20 mg (equivalent to 21.664 mg Quinapril Hydrochloride), or 40 mg (equivalent to 43.328 mg Quinapril Hydrochloride) of quinapril for oral administration. Each film-coated tablet also contains crospovidone, iron oxide yellow, lecithin, magnesium carbonate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, povidone, talc, titanium dioxide and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>71610-635-53</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71610-635-53) </PackageDescription>
<NDC11Code>71610-0635-53</NDC11Code>
<ProductNDC>71610-635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076796</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide Tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: corn starch NF, lactose monohydrate NF, magnesium stearate NF, pregelatinized starch NF, and talc USP. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is available as white-off white tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Tested by USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>71610-635-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71610-635-60) </PackageDescription>
<NDC11Code>71610-0635-60</NDC11Code>
<ProductNDC>71610-635</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076796</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide Tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: corn starch NF, lactose monohydrate NF, magnesium stearate NF, pregelatinized starch NF, and talc USP. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is available as white-off white tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Tested by USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>62332-001-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (62332-001-60) </PackageDescription>
<NDC11Code>62332-0001-60</NDC11Code>
<ProductNDC>62332-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078916</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62332-002-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (62332-002-60) </PackageDescription>
<NDC11Code>62332-0002-60</NDC11Code>
<ProductNDC>62332-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078916</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62332-039-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (62332-039-60) </PackageDescription>
<NDC11Code>62332-0039-60</NDC11Code>
<ProductNDC>62332-039</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090607</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine is indicated for. Epilepsy - adjunctive therapy in patients aged 2 years and older: : 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures. , 3 generalized seizures of Lennox-Gastaut syndrome.(1.1) .</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as -triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine Tablets USP are supplied for oral administration as 25-mg, 100-mg, 150-mg and 200-mg white to off white tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose monohydrate, magnesium stearate, povidone, sodium starch glycolate and talc.It meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>62332-040-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (62332-040-60) </PackageDescription>
<NDC11Code>62332-0040-60</NDC11Code>
<ProductNDC>62332-040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090607</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine is indicated for. Epilepsy - adjunctive therapy in patients aged 2 years and older: : 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures. , 3 generalized seizures of Lennox-Gastaut syndrome.(1.1) .</IndicationAndUsage>
<Description>Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as -triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. Lamotrigine Tablets USP are supplied for oral administration as 25-mg, 100-mg, 150-mg and 200-mg white to off white tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose monohydrate, magnesium stearate, povidone, sodium starch glycolate and talc.It meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>62332-061-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (62332-061-60) </PackageDescription>
<NDC11Code>62332-0061-60</NDC11Code>
<ProductNDC>62332-061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Leflunomide</ProprietaryName>
<NonProprietaryName>Leflunomide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091369</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LEFLUNOMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Leflunomide tablets USP are indicated for the treatment of adults with active rheumatoid arthritis (RA).</IndicationAndUsage>
<Description>Leflunomide USP is a pyrimidine synthesis inhibitor. The chemical name for leflunomide is N-(4´-trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide. It has an empirical formula C12H9F3N2O2, a molecular weight of 270.2 and the following structural formula. Leflunomide tablets USP are available for oral administration as tablets containing 10 mg or 20 mg of active drug. Combined with leflunomide are the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, iron oxide yellow (20 mg tablet only), lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>62332-062-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (62332-062-60) </PackageDescription>
<NDC11Code>62332-0062-60</NDC11Code>
<ProductNDC>62332-062</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Leflunomide</ProprietaryName>
<NonProprietaryName>Leflunomide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091369</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LEFLUNOMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Leflunomide tablets USP are indicated for the treatment of adults with active rheumatoid arthritis (RA).</IndicationAndUsage>
<Description>Leflunomide USP is a pyrimidine synthesis inhibitor. The chemical name for leflunomide is N-(4´-trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide. It has an empirical formula C12H9F3N2O2, a molecular weight of 270.2 and the following structural formula. Leflunomide tablets USP are available for oral administration as tablets containing 10 mg or 20 mg of active drug. Combined with leflunomide are the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, iron oxide yellow (20 mg tablet only), lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>62332-063-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (62332-063-60) </PackageDescription>
<NDC11Code>62332-0063-60</NDC11Code>
<ProductNDC>62332-063</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine Tartrate</ProprietaryName>
<NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091689</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivastigmine tartrate capsules are an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild-to-moderate dementia of the Alzheimer’s type (AD) (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD) (1.2).</IndicationAndUsage>
<Description>Rivastigmine tartrate is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt – hta salt) and a molecular weight of 400.43 g/mol (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3. Rivastigmine Tartrate Capsules USP contain rivastigmine tartrate , equivalent to 1.5 mg, 3 mg, 4.5 mg and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides.</Description>
</NDC>
<NDC>
<NDCCode>62332-064-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (62332-064-60) </PackageDescription>
<NDC11Code>62332-0064-60</NDC11Code>
<ProductNDC>62332-064</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine Tartrate</ProprietaryName>
<NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091689</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivastigmine tartrate capsules are an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild-to-moderate dementia of the Alzheimer’s type (AD) (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD) (1.2).</IndicationAndUsage>
<Description>Rivastigmine tartrate is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt – hta salt) and a molecular weight of 400.43 g/mol (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3. Rivastigmine Tartrate Capsules USP contain rivastigmine tartrate , equivalent to 1.5 mg, 3 mg, 4.5 mg and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides.</Description>
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<IndicationAndUsage>Rivastigmine tartrate capsules are an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild-to-moderate dementia of the Alzheimer’s type (AD) (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD) (1.2).</IndicationAndUsage>
<Description>Rivastigmine tartrate is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt – hta salt) and a molecular weight of 400.43 g/mol (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3. Rivastigmine Tartrate Capsules USP contain rivastigmine tartrate , equivalent to 1.5 mg, 3 mg, 4.5 mg and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivastigmine tartrate capsules are an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild-to-moderate dementia of the Alzheimer’s type (AD) (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD) (1.2).</IndicationAndUsage>
<Description>Rivastigmine tartrate is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 C4H6O6 (hydrogen tartrate salt – hta salt) and a molecular weight of 400.43 g/mol (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3. Rivastigmine Tartrate Capsules USP contain rivastigmine tartrate , equivalent to 1.5 mg, 3 mg, 4.5 mg and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides.</Description>
</NDC>
<NDC>
<NDCCode>62332-075-60</NDCCode>
<PackageDescription>60 TABLET, COATED in 1 BOTTLE (62332-075-60) </PackageDescription>
<NDC11Code>62332-0075-60</NDC11Code>
<ProductNDC>62332-075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200891</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-10-15</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride is indiacted for the treatment of moderate to severe dementia of the Alzheimer's type.</IndicationAndUsage>
<Description>Memantine hydrochloride 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 C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in methanol and sparingly soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, macrogol/polyethylene glycol 400, FD&C yellow #6 aluminum lake and FD&C blue #2 aluminum lake (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets).</Description>
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<NDCCode>62332-076-60</NDCCode>
<PackageDescription>60 TABLET, COATED in 1 BOTTLE (62332-076-60) </PackageDescription>
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<ProductNDC>62332-076</ProductNDC>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20151013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200891</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
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<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride is indiacted for the treatment of moderate to severe dementia of the Alzheimer's type.</IndicationAndUsage>
<Description>Memantine hydrochloride 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 C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in methanol and sparingly soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, macrogol/polyethylene glycol 400, FD&C yellow #6 aluminum lake and FD&C blue #2 aluminum lake (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets).</Description>
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