{
"NDC": [
{
"NDCCode": "63304-719-90",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-719-90) ",
"NDC11Code": "63304-0719-90",
"ProductNDC": "63304-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203023",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181031",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5 H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odorless crystalline powder or small crystals. It is freely soluble in chloroform, formic acid, methanol, and water. It is sparingly soluble in dehydrated alcohol and is insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules also contain: acetyl tributyl citrate, ammonio methacrylate copolymer dispersion, hypromellose, sodium lauryl sulfate, sugar spheres (sucrose and corn starch), and talc. The 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg capsule shells contain FD&C Blue #1, gelatin, sodium lauryl sulfate, and titanium dioxide. The 180 mg, 240 mg, 300 mg, and 360 mg capsule shells also contain iron oxide black. The 120 mg, 180 mg, 300 mg, and 360 mg capsules are imprinted with black ink which contains iron oxide black, potassium hydroxide, propylene glycol, and shellac. The 240 mg capsules are imprinted with white ink which contains potassium hydroxide, propylene glycol, shellac, and titanium dioxide. For oral administration. Meets USP dissolution test 29."
},
{
"NDCCode": "63304-719-05",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-719-05) ",
"NDC11Code": "63304-0719-05",
"ProductNDC": "63304-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203023",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181031",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5 H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odorless crystalline powder or small crystals. It is freely soluble in chloroform, formic acid, methanol, and water. It is sparingly soluble in dehydrated alcohol and is insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules also contain: acetyl tributyl citrate, ammonio methacrylate copolymer dispersion, hypromellose, sodium lauryl sulfate, sugar spheres (sucrose and corn starch), and talc. The 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg capsule shells contain FD&C Blue #1, gelatin, sodium lauryl sulfate, and titanium dioxide. The 180 mg, 240 mg, 300 mg, and 360 mg capsule shells also contain iron oxide black. The 120 mg, 180 mg, 300 mg, and 360 mg capsules are imprinted with black ink which contains iron oxide black, potassium hydroxide, propylene glycol, and shellac. The 240 mg capsules are imprinted with white ink which contains potassium hydroxide, propylene glycol, shellac, and titanium dioxide. For oral administration. Meets USP dissolution test 29."
},
{
"NDCCode": "63304-719-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-719-30) ",
"NDC11Code": "63304-0719-30",
"ProductNDC": "63304-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203023",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181031",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5 H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odorless crystalline powder or small crystals. It is freely soluble in chloroform, formic acid, methanol, and water. It is sparingly soluble in dehydrated alcohol and is insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules also contain: acetyl tributyl citrate, ammonio methacrylate copolymer dispersion, hypromellose, sodium lauryl sulfate, sugar spheres (sucrose and corn starch), and talc. The 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg capsule shells contain FD&C Blue #1, gelatin, sodium lauryl sulfate, and titanium dioxide. The 180 mg, 240 mg, 300 mg, and 360 mg capsule shells also contain iron oxide black. The 120 mg, 180 mg, 300 mg, and 360 mg capsules are imprinted with black ink which contains iron oxide black, potassium hydroxide, propylene glycol, and shellac. The 240 mg capsules are imprinted with white ink which contains potassium hydroxide, propylene glycol, shellac, and titanium dioxide. For oral administration. Meets USP dissolution test 29."
},
{
"NDCCode": "35356-719-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (35356-719-90) ",
"NDC11Code": "35356-0719-90",
"ProductNDC": "35356-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonazepam",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074869",
"LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20090213",
"SamplePackage": "N"
},
{
"NDCCode": "41226-719-09",
"PackageDescription": "1 BOTTLE in 1 CARTON (41226-719-09) / 90 TABLET in 1 BOTTLE",
"NDC11Code": "41226-0719-09",
"ProductNDC": "41226-719",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Original Strength Heartburn Prevention",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230505",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217543",
"LabelerName": "KROGER COMPANY",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240415",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 relieves heartburn associated with acid indigestion and sour stomach, 2 prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages."
},
{
"NDCCode": "42291-719-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42291-719-90)",
"NDC11Code": "42291-0719-90",
"ProductNDC": "42291-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Repaglinide",
"NonProprietaryName": "Repaglinide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077571",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "REPAGLINIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Glinide [EPC],Potassium Channel Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-11-08"
},
{
"NDCCode": "43353-719-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (43353-719-60)",
"NDC11Code": "43353-0719-60",
"ProductNDC": "43353-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrochlorothiazide",
"NonProprietaryName": "Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19730112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA083177",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "HYDROCHLOROTHIAZIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2017-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110413",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.",
"Description": "Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. C7H8ClN3O4S2 M.W. 297.74. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: corn starch, dibasic calcium phosphate, FD&C Yellow No. 6 Lake, lactose monohydrate and magnesium stearate."
},
{
"NDCCode": "55289-719-90",
"PackageDescription": "90 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-719-90) ",
"NDC11Code": "55289-0719-90",
"ProductNDC": "55289-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076003",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2018-11-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140715",
"SamplePackage": "N"
},
{
"NDCCode": "59746-719-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (59746-719-90) ",
"NDC11Code": "59746-0719-90",
"ProductNDC": "59746-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eslicarbazepine Acetate",
"NonProprietaryName": "Eslicarbazepine Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211219",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "ESLICARBAZEPINE ACETATE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260501",
"SamplePackage": "N",
"IndicationAndUsage": "Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
"Description": "The chemical name of eslicarbazepine acetate is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. Eslicarbazepine acetate is a white to almost white crystalline powder. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: hypromellose, magnesium stearate, and sodium starch glycolate."
},
{
"NDCCode": "62135-719-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-719-90) ",
"NDC11Code": "62135-0719-90",
"ProductNDC": "62135-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benazepril Hydrochloride",
"NonProprietaryName": "Benazepril Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076267",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2024-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230720",
"SamplePackage": "N",
"IndicationAndUsage": "Benazepril hydrochloride is 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. Benazepril hydrochloride is 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. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hyper-tension 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. It may be used alone or in combination with thiazide diuretics.",
"Description": "Benazepril hydrochloride, USP is a white to off-white crystalline powder, soluble (> 100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3phenyl-(1S)-propyl] amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Each benazepril hydrochloride tablet, USP contains 5 mg, 10 mg, 20 mg, or 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are colloidal silicon dioxide, crospovidone, FD&C yellow #6 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide, and triacetin. In addition, the 5 mg and 10 mg contain D&C yellow #10 Aluminum Lake, and the 20 mg and 40 mg contain FD&C red #40 Aluminum Lake. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "68180-719-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (68180-719-09) ",
"NDC11Code": "68180-0719-09",
"ProductNDC": "68180-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181031",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078043",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181031",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine besylate tablets are calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of. Hypertension (1.1). о Amlodipine besylate tablets 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. Coronary Artery Disease (1.2). о Chronic Stable Angina. о Vasospastic Angina (Prinzmetal's or Variant Angina). о Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.",
"Description": "Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets USP are formulated as tablets equivalent to 2.5 mg, 5 mg and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dicalcium phosphate anhydrous, FD & C red no. 40 aluminum lake (only for 2.5 mg strength), magnesium stearate, microcrystalline cellulose and povidone. Amlodipine besylate tablets USP meet USP Dissolution Test 2."
},
{
"NDCCode": "70934-719-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-719-90) ",
"NDC11Code": "70934-0719-90",
"ProductNDC": "70934-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200521",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200981",
"LabelerName": "Denton Pharma, Inc. dba Northwind Pharmaceuticals",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200521",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension. Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris. Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Myocardial Infarction. Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral Metoprolol tartrate tablets therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event. (See DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS).",
"Description": "Metoprolol tartrate is a selective beta 1-adrenoreceptor blocking agent, available as 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt. Its structural formula is:. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Each tablet for oral administration contains 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg of metoprolol tartrate and the following inactive ingredients: lactose monohydrate, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, sodium starch glycolate, talc and D & C Red #30 Aluminium Lake."
},
{
"NDCCode": "71205-719-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71205-719-90) ",
"NDC11Code": "71205-0719-90",
"ProductNDC": "71205-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065093",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20221116",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium tablets are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*.",
"Description": "Amoxicillin and clavulanate potassium is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:. Tablets - Colloidal silicon dioxide, croscarmellose sodium dried, crospovidone dried, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, microcrystalline cellulose dried, polysorbate 80, talc, titanium dioxide, triethyl citrate. Each tablet of amoxicillin and clavulanate potassium contains 0.63 mEq potassium."
},
{
"NDCCode": "76420-719-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (76420-719-90) ",
"NDC11Code": "76420-0719-90",
"ProductNDC": "76420-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077584",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240506",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).",
"Description": "Paroxetine tablets, USP contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride, USP is an odorless, white to off-white crystalline powder, having a melting point range of 120°C to 138°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in dichloromethane and slightly soluble in water. Paroxetine tablets are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide."
},
{
"NDCCode": "63304-086-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (63304-086-90) ",
"NDC11Code": "63304-0086-90",
"ProductNDC": "63304-086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Droxidopa",
"NonProprietaryName": "Droxidopa",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214384",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DROXIDOPA",
"StrengthNumber": "100",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Catecholamines [CS], Increased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2021-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210218",
"SamplePackage": "N",
"IndicationAndUsage": "Droxidopa capsules are indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of droxidopa capsules should be assessed periodically.",
"Description": "Droxidopa capsules contain droxidopa, which is a synthetic amino acid precursor of norepinephrine, for oral administration. Chemically, droxidopa is (–)-threo-3-(3,4-Dihydroxyphenyl)-L-serine. It has the following structural formula. Droxidopa is a white to light brown crystalline powder. It is soluble in dilute hydrochloric acid and practically insoluble in methanol, glacial acetic acid, ethanol, acetone, ether, and chloroform. It has a molecular weight of 213.19 and a molecular formula of C9H11NO5. Droxidopa capsules also contain the following inactive ingredients: corn starch, magnesium stearate, and mannitol. The capsule shell is printed with black ink. The black inks contain ferrosoferric oxide, potassium hydroxide, and shellac. The capsule shell contains the following inactive ingredients: 100 mg–FD&C Blue No. 2, gelatin, titanium dioxide; 200 mg–ferric oxide yellow, gelatin, titanium dioxide; 300 mg–FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 5 (tartrazine), gelatin, titanium dioxide. Droxidopa capsules differ in size and color by strength [see Dosage Forms and Strengths (3)]."
},
{
"NDCCode": "63304-104-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (63304-104-90) ",
"NDC11Code": "63304-0104-90",
"ProductNDC": "63304-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Droxidopa",
"NonProprietaryName": "Droxidopa",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214384",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DROXIDOPA",
"StrengthNumber": "200",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Catecholamines [CS], Increased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2021-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210218",
"SamplePackage": "N",
"IndicationAndUsage": "Droxidopa capsules are indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of droxidopa capsules should be assessed periodically.",
"Description": "Droxidopa capsules contain droxidopa, which is a synthetic amino acid precursor of norepinephrine, for oral administration. Chemically, droxidopa is (–)-threo-3-(3,4-Dihydroxyphenyl)-L-serine. It has the following structural formula. Droxidopa is a white to light brown crystalline powder. It is soluble in dilute hydrochloric acid and practically insoluble in methanol, glacial acetic acid, ethanol, acetone, ether, and chloroform. It has a molecular weight of 213.19 and a molecular formula of C9H11NO5. Droxidopa capsules also contain the following inactive ingredients: corn starch, magnesium stearate, and mannitol. The capsule shell is printed with black ink. The black inks contain ferrosoferric oxide, potassium hydroxide, and shellac. The capsule shell contains the following inactive ingredients: 100 mg–FD&C Blue No. 2, gelatin, titanium dioxide; 200 mg–ferric oxide yellow, gelatin, titanium dioxide; 300 mg–FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 5 (tartrazine), gelatin, titanium dioxide. Droxidopa capsules differ in size and color by strength [see Dosage Forms and Strengths (3)]."
},
{
"NDCCode": "63304-112-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (63304-112-90) ",
"NDC11Code": "63304-0112-90",
"ProductNDC": "63304-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Droxidopa",
"NonProprietaryName": "Droxidopa",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214384",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DROXIDOPA",
"StrengthNumber": "300",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Catecholamines [CS], Increased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2021-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210218",
"SamplePackage": "N",
"IndicationAndUsage": "Droxidopa capsules are indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of droxidopa capsules should be assessed periodically.",
"Description": "Droxidopa capsules contain droxidopa, which is a synthetic amino acid precursor of norepinephrine, for oral administration. Chemically, droxidopa is (–)-threo-3-(3,4-Dihydroxyphenyl)-L-serine. It has the following structural formula. Droxidopa is a white to light brown crystalline powder. It is soluble in dilute hydrochloric acid and practically insoluble in methanol, glacial acetic acid, ethanol, acetone, ether, and chloroform. It has a molecular weight of 213.19 and a molecular formula of C9H11NO5. Droxidopa capsules also contain the following inactive ingredients: corn starch, magnesium stearate, and mannitol. The capsule shell is printed with black ink. The black inks contain ferrosoferric oxide, potassium hydroxide, and shellac. The capsule shell contains the following inactive ingredients: 100 mg–FD&C Blue No. 2, gelatin, titanium dioxide; 200 mg–ferric oxide yellow, gelatin, titanium dioxide; 300 mg–FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 5 (tartrazine), gelatin, titanium dioxide. Droxidopa capsules differ in size and color by strength [see Dosage Forms and Strengths (3)]."
},
{
"NDCCode": "63304-128-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (63304-128-90)",
"NDC11Code": "63304-0128-90",
"ProductNDC": "63304-128",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076786",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Donepezil is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.",
"Description": "Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has a molecular formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride (monohydrate), USP is a white to off-white crystalline powder and is soluble in chloroform, sparingly soluble in water, methanol and acetic acid. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5 or 10 mg of donepezil hydrochloride (monohydrate), USP. Inactive ingredients in 5 mg and 10 mg tablets are corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coating contains hypromellose, ferric oxide yellow, polyethylene glycol, talc and titanium dioxide. Complies with USP Organic Impurities, Procedure 2."
},
{
"NDCCode": "63304-129-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (63304-129-90)",
"NDC11Code": "63304-0129-90",
"ProductNDC": "63304-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076786",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Donepezil is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.",
"Description": "Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has a molecular formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride (monohydrate), USP is a white to off-white crystalline powder and is soluble in chloroform, sparingly soluble in water, methanol and acetic acid. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5 or 10 mg of donepezil hydrochloride (monohydrate), USP. Inactive ingredients in 5 mg and 10 mg tablets are corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coating contains hypromellose, ferric oxide yellow, polyethylene glycol, talc and titanium dioxide. Complies with USP Organic Impurities, Procedure 2."
},
{
"NDCCode": "63304-191-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-191-90) ",
"NDC11Code": "63304-0191-90",
"ProductNDC": "63304-191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130305",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204150",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DESVENLAFAXINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130305",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].",
"Description": "Desvenlafaxine extended-release tablets for oral administration contains desvenlafaxine, USP, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine), USP is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine, USP is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2. Desvenlafaxine, USP has a molecular weight of 263.38. The structural formula is shown below. * Chiral Centre. Desvenlafaxine, USP is a white to off-white crystalline powder that is sparingly soluble in dimethyl sulfoxide. The solubility of desvenlafaxine is pH dependent. Desvenlafaxine, USP is formulated as an extended-release tablet for once-a-day oral administration. Each 50 mg or 100 mg extended-release tablet contains 50 or 100 mg of desvenlafaxine, USP, respectively. Inactive ingredients for the 50 mg tablet consist of alginic acid, citric acid monohydrate powder, hypromellose, microcrystalline cellulose, povidone, talc, magnesium stearate and film coating, which consist of hypromellose, titanium dioxide, polyethylene glycol, talc, and iron oxide red. Inactive ingredients for the 100 mg tablet consist of alginic acid, citric acid monohydrate powder, hypromellose, microcrystalline cellulose, povidone, talc, magnesium stearate and film coating, which consist of hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide black."
},
{
"NDCCode": "63304-192-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-192-90) ",
"NDC11Code": "63304-0192-90",
"ProductNDC": "63304-192",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desvenlafaxine",
"NonProprietaryName": "Desvenlafaxine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130305",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204150",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "DESVENLAFAXINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130305",
"SamplePackage": "N",
"IndicationAndUsage": "Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].",
"Description": "Desvenlafaxine extended-release tablets for oral administration contains desvenlafaxine, USP, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine), USP is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine, USP is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2. Desvenlafaxine, USP has a molecular weight of 263.38. The structural formula is shown below. * Chiral Centre. Desvenlafaxine, USP is a white to off-white crystalline powder that is sparingly soluble in dimethyl sulfoxide. The solubility of desvenlafaxine is pH dependent. Desvenlafaxine, USP is formulated as an extended-release tablet for once-a-day oral administration. Each 50 mg or 100 mg extended-release tablet contains 50 or 100 mg of desvenlafaxine, USP, respectively. Inactive ingredients for the 50 mg tablet consist of alginic acid, citric acid monohydrate powder, hypromellose, microcrystalline cellulose, povidone, talc, magnesium stearate and film coating, which consist of hypromellose, titanium dioxide, polyethylene glycol, talc, and iron oxide red. Inactive ingredients for the 100 mg tablet consist of alginic acid, citric acid monohydrate powder, hypromellose, microcrystalline cellulose, povidone, talc, magnesium stearate and film coating, which consist of hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide black."
},
{
"NDCCode": "63304-254-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (63304-254-90)",
"NDC11Code": "63304-0254-90",
"ProductNDC": "63304-254",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202467",
"LabelerName": "Ranbaxy Pharmaceuticals Inc",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-01-22"
},
{
"NDCCode": "63304-255-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (63304-255-90)",
"NDC11Code": "63304-0255-90",
"ProductNDC": "63304-255",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202467",
"LabelerName": "Ranbaxy Pharmaceuticals Inc",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-01-22"
},
{
"NDCCode": "63304-261-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (63304-261-90)",
"NDC11Code": "63304-0261-90",
"ProductNDC": "63304-261",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202467",
"LabelerName": "Ranbaxy Pharmaceuticals Inc",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-01-22"
},
{
"NDCCode": "63304-311-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (63304-311-90)",
"NDC11Code": "63304-0311-90",
"ProductNDC": "63304-311",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120817",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021073",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (1.1, 14). Important Limitation of Use: 1 Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1.2).",
"Description": "Pioglitazone tablets are an oral antidiabetic medication. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets are available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate NF, hydroxypropylcellulose NF, carboxymethylcellulose calcium NF, and magnesium stearate NF."
},
{
"NDCCode": "63304-312-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (63304-312-90)",
"NDC11Code": "63304-0312-90",
"ProductNDC": "63304-312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120817",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021073",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (1.1, 14). Important Limitation of Use: 1 Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1.2).",
"Description": "Pioglitazone tablets are an oral antidiabetic medication. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets are available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate NF, hydroxypropylcellulose NF, carboxymethylcellulose calcium NF, and magnesium stearate NF."
},
{
"NDCCode": "63304-313-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (63304-313-90)",
"NDC11Code": "63304-0313-90",
"ProductNDC": "63304-313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pioglitazone",
"NonProprietaryName": "Pioglitazone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120817",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021073",
"LabelerName": "Ranbaxy Pharmaceuticals Inc.",
"SubstanceName": "PIOGLITAZONE HYDROCHLORIDE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (1.1, 14). Important Limitation of Use: 1 Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1.2).",
"Description": "Pioglitazone tablets are an oral antidiabetic medication. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets are available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate NF, hydroxypropylcellulose NF, carboxymethylcellulose calcium NF, and magnesium stearate NF."
},
{
"NDCCode": "63304-444-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (63304-444-90) ",
"NDC11Code": "63304-0444-90",
"ProductNDC": "63304-444",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201748",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "130",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150302",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate capsules, USP are peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL) (1)., 2 to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible (1).",
"Description": "Fenofibrate capsules, USP, is a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as capsules for oral administration. Each capsule contains 43 mg or 130 mg of micronized fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, l-methylethyl ester with the following structural formula. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate (micronized), USP is practically insoluble in water, very soluble in methylene chloride, slightly soluble in alcohol. The melting point is 79° to 82° C. Fenofibrate (micronized), USP is a white or almost white crystalline powder. Inactive Ingredients: Each gelatin capsule contains hypromellose, pregelatinized starch (maize), simethicone emulsion, sodium lauryl sulfate, sodium stearyl fumarate and talc. The gelatin capsules also contain gelatin and titanium dioxide. The imprinting ink contains ferric oxide black, potassium hydroxide, propylene glycol, and shellac. Meets USP Dissolution Test 2."
},
{
"NDCCode": "63304-448-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (63304-448-90) ",
"NDC11Code": "63304-0448-90",
"ProductNDC": "63304-448",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200884",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "48",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "N",
"Description": "Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79-82° C. Fenofibrate, USP is a white or almost white crystalline powder. Inactive Ingredients. Each film-coated tablet contains colloidal silicon dioxide, crospovidone, hypromellose (3 cps), microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, sucrose, sodium lauryl sulfate, sodium stearyl fumarate, soybean lecithin, talc, titanium dioxide, and xanthan gum. Meets USP Dissolution Test 1."
},
{
"NDCCode": "63304-449-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (63304-449-90) ",
"NDC11Code": "63304-0449-90",
"ProductNDC": "63304-449",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200884",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "145",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "N",
"Description": "Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The molecular formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79-82° C. Fenofibrate, USP is a white or almost white crystalline powder. Inactive Ingredients. Each film-coated tablet contains colloidal silicon dioxide, crospovidone, hypromellose (3 cps), microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, sucrose, sodium lauryl sulfate, sodium stearyl fumarate, soybean lecithin, talc, titanium dioxide, and xanthan gum. Meets USP Dissolution Test 1."
}
]
}
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<NDCList>
<NDC>
<NDCCode>63304-719-90</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-719-90) </PackageDescription>
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<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5 H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odorless crystalline powder or small crystals. It is freely soluble in chloroform, formic acid, methanol, and water. It is sparingly soluble in dehydrated alcohol and is insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules also contain: acetyl tributyl citrate, ammonio methacrylate copolymer dispersion, hypromellose, sodium lauryl sulfate, sugar spheres (sucrose and corn starch), and talc. The 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg capsule shells contain FD&C Blue #1, gelatin, sodium lauryl sulfate, and titanium dioxide. The 180 mg, 240 mg, 300 mg, and 360 mg capsule shells also contain iron oxide black. The 120 mg, 180 mg, 300 mg, and 360 mg capsules are imprinted with black ink which contains iron oxide black, potassium hydroxide, propylene glycol, and shellac. The 240 mg capsules are imprinted with white ink which contains potassium hydroxide, propylene glycol, shellac, and titanium dioxide. For oral administration. Meets USP dissolution test 29.</Description>
</NDC>
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<NDCCode>63304-719-05</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-719-05) </PackageDescription>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5 H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odorless crystalline powder or small crystals. It is freely soluble in chloroform, formic acid, methanol, and water. It is sparingly soluble in dehydrated alcohol and is insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules also contain: acetyl tributyl citrate, ammonio methacrylate copolymer dispersion, hypromellose, sodium lauryl sulfate, sugar spheres (sucrose and corn starch), and talc. The 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg capsule shells contain FD&C Blue #1, gelatin, sodium lauryl sulfate, and titanium dioxide. The 180 mg, 240 mg, 300 mg, and 360 mg capsule shells also contain iron oxide black. The 120 mg, 180 mg, 300 mg, and 360 mg capsules are imprinted with black ink which contains iron oxide black, potassium hydroxide, propylene glycol, and shellac. The 240 mg capsules are imprinted with white ink which contains potassium hydroxide, propylene glycol, shellac, and titanium dioxide. For oral administration. Meets USP dissolution test 29.</Description>
</NDC>
<NDC>
<NDCCode>63304-719-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-719-30) </PackageDescription>
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<ProductNDC>63304-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1, 5-Benzothiazepin-4(5 H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis-. The chemical structure is:. Diltiazem hydrochloride, USP is a white, odorless crystalline powder or small crystals. It is freely soluble in chloroform, formic acid, methanol, and water. It is sparingly soluble in dehydrated alcohol and is insoluble in ether. It has a molecular weight of 450.98. Diltiazem hydrochloride is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride, USP (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride, USP (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride, USP (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride, USP (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride, USP (equivalent to 330.9 mg diltiazem). The 120 mg, 180 mg, 240 mg, 300 mg and 360 mg capsules also contain: acetyl tributyl citrate, ammonio methacrylate copolymer dispersion, hypromellose, sodium lauryl sulfate, sugar spheres (sucrose and corn starch), and talc. The 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg capsule shells contain FD&C Blue #1, gelatin, sodium lauryl sulfate, and titanium dioxide. The 180 mg, 240 mg, 300 mg, and 360 mg capsule shells also contain iron oxide black. The 120 mg, 180 mg, 300 mg, and 360 mg capsules are imprinted with black ink which contains iron oxide black, potassium hydroxide, propylene glycol, and shellac. The 240 mg capsules are imprinted with white ink which contains potassium hydroxide, propylene glycol, shellac, and titanium dioxide. For oral administration. Meets USP dissolution test 29.</Description>
</NDC>
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<PackageDescription>90 TABLET in 1 BOTTLE (35356-719-90) </PackageDescription>
<NDC11Code>35356-0719-90</NDC11Code>
<ProductNDC>35356-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonazepam</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074869</ApplicationNumber>
<LabelerName>Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41226-719-09</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (41226-719-09) / 90 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>41226-0719-09</NDC11Code>
<ProductNDC>41226-719</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Original Strength Heartburn Prevention</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230505</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217543</ApplicationNumber>
<LabelerName>KROGER COMPANY</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 relieves heartburn associated with acid indigestion and sour stomach, 2 prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42291-719-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42291-719-90)</PackageDescription>
<NDC11Code>42291-0719-90</NDC11Code>
<ProductNDC>42291-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Repaglinide</ProprietaryName>
<NonProprietaryName>Repaglinide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077571</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>REPAGLINIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Glinide [EPC],Potassium Channel Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>43353-719-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (43353-719-60)</PackageDescription>
<NDC11Code>43353-0719-60</NDC11Code>
<ProductNDC>43353-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19730112</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA083177</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2017-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.</IndicationAndUsage>
<Description>Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. C7H8ClN3O4S2 M.W. 297.74. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: corn starch, dibasic calcium phosphate, FD&C Yellow No. 6 Lake, lactose monohydrate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>55289-719-90</NDCCode>
<PackageDescription>90 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-719-90) </PackageDescription>
<NDC11Code>55289-0719-90</NDC11Code>
<ProductNDC>55289-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076003</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-11-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59746-719-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (59746-719-90) </PackageDescription>
<NDC11Code>59746-0719-90</NDC11Code>
<ProductNDC>59746-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eslicarbazepine Acetate</ProprietaryName>
<NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211219</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESLICARBAZEPINE ACETATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
<Description>The chemical name of eslicarbazepine acetate is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. Eslicarbazepine acetate is a white to almost white crystalline powder. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: hypromellose, magnesium stearate, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>62135-719-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-719-90) </PackageDescription>
<NDC11Code>62135-0719-90</NDC11Code>
<ProductNDC>62135-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220820</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076267</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benazepril hydrochloride is 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. Benazepril hydrochloride is 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. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hyper-tension 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. It may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
<Description>Benazepril hydrochloride, USP is a white to off-white crystalline powder, soluble (> 100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3phenyl-(1S)-propyl] amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Each benazepril hydrochloride tablet, USP contains 5 mg, 10 mg, 20 mg, or 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are colloidal silicon dioxide, crospovidone, FD&C yellow #6 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide, and triacetin. In addition, the 5 mg and 10 mg contain D&C yellow #10 Aluminum Lake, and the 20 mg and 40 mg contain FD&C red #40 Aluminum Lake. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>68180-719-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68180-719-09) </PackageDescription>
<NDC11Code>68180-0719-09</NDC11Code>
<ProductNDC>68180-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181031</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078043</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181031</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine besylate tablets are calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of. Hypertension (1.1). о Amlodipine besylate tablets 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. Coronary Artery Disease (1.2). о Chronic Stable Angina. о Vasospastic Angina (Prinzmetal's or Variant Angina). о Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.</IndicationAndUsage>
<Description>Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S, and its structural formula is. Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets USP are formulated as tablets equivalent to 2.5 mg, 5 mg and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dicalcium phosphate anhydrous, FD & C red no. 40 aluminum lake (only for 2.5 mg strength), magnesium stearate, microcrystalline cellulose and povidone. Amlodipine besylate tablets USP meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>70934-719-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-719-90) </PackageDescription>
<NDC11Code>70934-0719-90</NDC11Code>
<ProductNDC>70934-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200521</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200981</ApplicationNumber>
<LabelerName>Denton Pharma, Inc. dba Northwind Pharmaceuticals</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200521</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension. Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris. Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. Myocardial Infarction. Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral Metoprolol tartrate tablets therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event. (See DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS).</IndicationAndUsage>
<Description>Metoprolol tartrate is a selective beta 1-adrenoreceptor blocking agent, available as 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p-2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro-tartrate salt. Its structural formula is:. Metoprolol tartrate, USP is a white, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Each tablet for oral administration contains 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg of metoprolol tartrate and the following inactive ingredients: lactose monohydrate, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, sodium starch glycolate, talc and D & C Red #30 Aluminium Lake.</Description>
</NDC>
<NDC>
<NDCCode>71205-719-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71205-719-90) </PackageDescription>
<NDC11Code>71205-0719-90</NDC11Code>
<ProductNDC>71205-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065093</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>875; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium tablets are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*.</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.46. Chemically, amoxicillin is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as. Inactive Ingredients:. Tablets - Colloidal silicon dioxide, croscarmellose sodium dried, crospovidone dried, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, microcrystalline cellulose dried, polysorbate 80, talc, titanium dioxide, triethyl citrate. Each tablet of amoxicillin and clavulanate potassium contains 0.63 mEq potassium.</Description>
</NDC>
<NDC>
<NDCCode>76420-719-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (76420-719-90) </PackageDescription>
<NDC11Code>76420-0719-90</NDC11Code>
<ProductNDC>76420-719</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077584</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
<Description>Paroxetine tablets, USP contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans-4 R-(4'-fluorophenyl)-3 S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C 19H 20FNO 3HCl1/2H 2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:. Paroxetine hydrochloride, USP is an odorless, white to off-white crystalline powder, having a melting point range of 120°C to 138°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in dichloromethane and slightly soluble in water. Paroxetine tablets are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>63304-086-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (63304-086-90) </PackageDescription>
<NDC11Code>63304-0086-90</NDC11Code>
<ProductNDC>63304-086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Droxidopa</ProprietaryName>
<NonProprietaryName>Droxidopa</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214384</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DROXIDOPA</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Catecholamines [CS], Increased Blood Pressure [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Droxidopa capsules are indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of droxidopa capsules should be assessed periodically.</IndicationAndUsage>
<Description>Droxidopa capsules contain droxidopa, which is a synthetic amino acid precursor of norepinephrine, for oral administration. Chemically, droxidopa is (–)-threo-3-(3,4-Dihydroxyphenyl)-L-serine. It has the following structural formula. Droxidopa is a white to light brown crystalline powder. It is soluble in dilute hydrochloric acid and practically insoluble in methanol, glacial acetic acid, ethanol, acetone, ether, and chloroform. It has a molecular weight of 213.19 and a molecular formula of C9H11NO5. Droxidopa capsules also contain the following inactive ingredients: corn starch, magnesium stearate, and mannitol. The capsule shell is printed with black ink. The black inks contain ferrosoferric oxide, potassium hydroxide, and shellac. The capsule shell contains the following inactive ingredients: 100 mg–FD&C Blue No. 2, gelatin, titanium dioxide; 200 mg–ferric oxide yellow, gelatin, titanium dioxide; 300 mg–FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 5 (tartrazine), gelatin, titanium dioxide. Droxidopa capsules differ in size and color by strength [see Dosage Forms and Strengths (3)].</Description>
</NDC>
<NDC>
<NDCCode>63304-104-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (63304-104-90) </PackageDescription>
<NDC11Code>63304-0104-90</NDC11Code>
<ProductNDC>63304-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Droxidopa</ProprietaryName>
<NonProprietaryName>Droxidopa</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214384</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DROXIDOPA</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Catecholamines [CS], Increased Blood Pressure [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Droxidopa capsules are indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of droxidopa capsules should be assessed periodically.</IndicationAndUsage>
<Description>Droxidopa capsules contain droxidopa, which is a synthetic amino acid precursor of norepinephrine, for oral administration. Chemically, droxidopa is (–)-threo-3-(3,4-Dihydroxyphenyl)-L-serine. It has the following structural formula. Droxidopa is a white to light brown crystalline powder. It is soluble in dilute hydrochloric acid and practically insoluble in methanol, glacial acetic acid, ethanol, acetone, ether, and chloroform. It has a molecular weight of 213.19 and a molecular formula of C9H11NO5. Droxidopa capsules also contain the following inactive ingredients: corn starch, magnesium stearate, and mannitol. The capsule shell is printed with black ink. The black inks contain ferrosoferric oxide, potassium hydroxide, and shellac. The capsule shell contains the following inactive ingredients: 100 mg–FD&C Blue No. 2, gelatin, titanium dioxide; 200 mg–ferric oxide yellow, gelatin, titanium dioxide; 300 mg–FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 5 (tartrazine), gelatin, titanium dioxide. Droxidopa capsules differ in size and color by strength [see Dosage Forms and Strengths (3)].</Description>
</NDC>
<NDC>
<NDCCode>63304-112-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (63304-112-90) </PackageDescription>
<NDC11Code>63304-0112-90</NDC11Code>
<ProductNDC>63304-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Droxidopa</ProprietaryName>
<NonProprietaryName>Droxidopa</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214384</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DROXIDOPA</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Catecholamines [CS], Increased Blood Pressure [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Droxidopa capsules are indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of droxidopa capsules should be assessed periodically.</IndicationAndUsage>
<Description>Droxidopa capsules contain droxidopa, which is a synthetic amino acid precursor of norepinephrine, for oral administration. Chemically, droxidopa is (–)-threo-3-(3,4-Dihydroxyphenyl)-L-serine. It has the following structural formula. Droxidopa is a white to light brown crystalline powder. It is soluble in dilute hydrochloric acid and practically insoluble in methanol, glacial acetic acid, ethanol, acetone, ether, and chloroform. It has a molecular weight of 213.19 and a molecular formula of C9H11NO5. Droxidopa capsules also contain the following inactive ingredients: corn starch, magnesium stearate, and mannitol. The capsule shell is printed with black ink. The black inks contain ferrosoferric oxide, potassium hydroxide, and shellac. The capsule shell contains the following inactive ingredients: 100 mg–FD&C Blue No. 2, gelatin, titanium dioxide; 200 mg–ferric oxide yellow, gelatin, titanium dioxide; 300 mg–FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 5 (tartrazine), gelatin, titanium dioxide. Droxidopa capsules differ in size and color by strength [see Dosage Forms and Strengths (3)].</Description>
</NDC>
<NDC>
<NDCCode>63304-128-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (63304-128-90)</PackageDescription>
<NDC11Code>63304-0128-90</NDC11Code>
<ProductNDC>63304-128</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076786</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Donepezil is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has a molecular formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride (monohydrate), USP is a white to off-white crystalline powder and is soluble in chloroform, sparingly soluble in water, methanol and acetic acid. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5 or 10 mg of donepezil hydrochloride (monohydrate), USP. Inactive ingredients in 5 mg and 10 mg tablets are corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coating contains hypromellose, ferric oxide yellow, polyethylene glycol, talc and titanium dioxide. Complies with USP Organic Impurities, Procedure 2.</Description>
</NDC>
<NDC>
<NDCCode>63304-129-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (63304-129-90)</PackageDescription>
<NDC11Code>63304-0129-90</NDC11Code>
<ProductNDC>63304-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
<NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076786</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Donepezil is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer’s type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.</IndicationAndUsage>
<Description>Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has a molecular formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride (monohydrate), USP is a white to off-white crystalline powder and is soluble in chloroform, sparingly soluble in water, methanol and acetic acid. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5 or 10 mg of donepezil hydrochloride (monohydrate), USP. Inactive ingredients in 5 mg and 10 mg tablets are corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coating contains hypromellose, ferric oxide yellow, polyethylene glycol, talc and titanium dioxide. Complies with USP Organic Impurities, Procedure 2.</Description>
</NDC>
<NDC>
<NDCCode>63304-191-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-191-90) </PackageDescription>
<NDC11Code>63304-0191-90</NDC11Code>
<ProductNDC>63304-191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine</ProprietaryName>
<NonProprietaryName>Desvenlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130305</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204150</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DESVENLAFAXINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Desvenlafaxine extended-release tablets for oral administration contains desvenlafaxine, USP, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine), USP is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine, USP is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2. Desvenlafaxine, USP has a molecular weight of 263.38. The structural formula is shown below. * Chiral Centre. Desvenlafaxine, USP is a white to off-white crystalline powder that is sparingly soluble in dimethyl sulfoxide. The solubility of desvenlafaxine is pH dependent. Desvenlafaxine, USP is formulated as an extended-release tablet for once-a-day oral administration. Each 50 mg or 100 mg extended-release tablet contains 50 or 100 mg of desvenlafaxine, USP, respectively. Inactive ingredients for the 50 mg tablet consist of alginic acid, citric acid monohydrate powder, hypromellose, microcrystalline cellulose, povidone, talc, magnesium stearate and film coating, which consist of hypromellose, titanium dioxide, polyethylene glycol, talc, and iron oxide red. Inactive ingredients for the 100 mg tablet consist of alginic acid, citric acid monohydrate powder, hypromellose, microcrystalline cellulose, povidone, talc, magnesium stearate and film coating, which consist of hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>63304-192-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-192-90) </PackageDescription>
<NDC11Code>63304-0192-90</NDC11Code>
<ProductNDC>63304-192</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desvenlafaxine</ProprietaryName>
<NonProprietaryName>Desvenlafaxine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130305</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204150</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>DESVENLAFAXINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Desvenlafaxine extended-release tablets for oral administration contains desvenlafaxine, USP, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine), USP is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine, USP is designated RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C16H25NO2. Desvenlafaxine, USP has a molecular weight of 263.38. The structural formula is shown below. * Chiral Centre. Desvenlafaxine, USP is a white to off-white crystalline powder that is sparingly soluble in dimethyl sulfoxide. The solubility of desvenlafaxine is pH dependent. Desvenlafaxine, USP is formulated as an extended-release tablet for once-a-day oral administration. Each 50 mg or 100 mg extended-release tablet contains 50 or 100 mg of desvenlafaxine, USP, respectively. Inactive ingredients for the 50 mg tablet consist of alginic acid, citric acid monohydrate powder, hypromellose, microcrystalline cellulose, povidone, talc, magnesium stearate and film coating, which consist of hypromellose, titanium dioxide, polyethylene glycol, talc, and iron oxide red. Inactive ingredients for the 100 mg tablet consist of alginic acid, citric acid monohydrate powder, hypromellose, microcrystalline cellulose, povidone, talc, magnesium stearate and film coating, which consist of hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>63304-254-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (63304-254-90)</PackageDescription>
<NDC11Code>63304-0254-90</NDC11Code>
<ProductNDC>63304-254</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202467</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>63304-255-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (63304-255-90)</PackageDescription>
<NDC11Code>63304-0255-90</NDC11Code>
<ProductNDC>63304-255</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202467</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>63304-261-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (63304-261-90)</PackageDescription>
<NDC11Code>63304-0261-90</NDC11Code>
<ProductNDC>63304-261</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202467</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>63304-311-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (63304-311-90)</PackageDescription>
<NDC11Code>63304-0311-90</NDC11Code>
<ProductNDC>63304-311</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120817</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021073</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (1.1, 14). Important Limitation of Use: 1 Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1.2).</IndicationAndUsage>
<Description>Pioglitazone tablets are an oral antidiabetic medication. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets are available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate NF, hydroxypropylcellulose NF, carboxymethylcellulose calcium NF, and magnesium stearate NF.</Description>
</NDC>
<NDC>
<NDCCode>63304-312-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (63304-312-90)</PackageDescription>
<NDC11Code>63304-0312-90</NDC11Code>
<ProductNDC>63304-312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120817</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021073</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (1.1, 14). Important Limitation of Use: 1 Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1.2).</IndicationAndUsage>
<Description>Pioglitazone tablets are an oral antidiabetic medication. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets are available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate NF, hydroxypropylcellulose NF, carboxymethylcellulose calcium NF, and magnesium stearate NF.</Description>
</NDC>
<NDC>
<NDCCode>63304-313-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (63304-313-90)</PackageDescription>
<NDC11Code>63304-0313-90</NDC11Code>
<ProductNDC>63304-313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pioglitazone</ProprietaryName>
<NonProprietaryName>Pioglitazone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120817</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021073</ApplicationNumber>
<LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PIOGLITAZONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (1.1, 14). Important Limitation of Use: 1 Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1.2).</IndicationAndUsage>
<Description>Pioglitazone tablets are an oral antidiabetic medication. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo. No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown. Pioglitazone hydrochloride is an odorless white crystalline powder that has a molecular formula of C19H20N2O3SHCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone Tablets are available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: lactose monohydrate NF, hydroxypropylcellulose NF, carboxymethylcellulose calcium NF, and magnesium stearate NF.</Description>
</NDC>
<NDC>
<NDCCode>63304-444-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (63304-444-90) </PackageDescription>
<NDC11Code>63304-0444-90</NDC11Code>
<ProductNDC>63304-444</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201748</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>130</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate capsules, USP are peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL) (1)., 2 to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible (1).</IndicationAndUsage>
<Description>Fenofibrate capsules, USP, is a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as capsules for oral administration. Each capsule contains 43 mg or 130 mg of micronized fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, l-methylethyl ester with the following structural formula. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate (micronized), USP is practically insoluble in water, very soluble in methylene chloride, slightly soluble in alcohol. The melting point is 79° to 82° C. Fenofibrate (micronized), USP is a white or almost white crystalline powder. Inactive Ingredients: Each gelatin capsule contains hypromellose, pregelatinized starch (maize), simethicone emulsion, sodium lauryl sulfate, sodium stearyl fumarate and talc. The gelatin capsules also contain gelatin and titanium dioxide. The imprinting ink contains ferric oxide black, potassium hydroxide, propylene glycol, and shellac. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>63304-448-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (63304-448-90) </PackageDescription>
<NDC11Code>63304-0448-90</NDC11Code>
<ProductNDC>63304-448</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200884</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>48</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The molecular formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79-82° C. Fenofibrate, USP is a white or almost white crystalline powder. Inactive Ingredients. Each film-coated tablet contains colloidal silicon dioxide, crospovidone, hypromellose (3 cps), microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, sucrose, sodium lauryl sulfate, sodium stearyl fumarate, soybean lecithin, talc, titanium dioxide, and xanthan gum. Meets USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>63304-449-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (63304-449-90) </PackageDescription>
<NDC11Code>63304-0449-90</NDC11Code>
<ProductNDC>63304-449</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200884</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>145</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The molecular formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79-82° C. Fenofibrate, USP is a white or almost white crystalline powder. Inactive Ingredients. Each film-coated tablet contains colloidal silicon dioxide, crospovidone, hypromellose (3 cps), microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, sucrose, sodium lauryl sulfate, sodium stearyl fumarate, soybean lecithin, talc, titanium dioxide, and xanthan gum. Meets USP Dissolution Test 1.</Description>
</NDC>
</NDCList>