{
"NDC": [
{
"NDCCode": "62332-556-45",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (62332-556-45) ",
"NDC11Code": "62332-0556-45",
"ProductNDC": "62332-556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213682",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "24; 26",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241104",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablet is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablet reduce NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. The active pharmaceutical ingredient used to manufacture sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5.The complexis chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)-water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is: Sacubitril and valsartan is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The inactive ingredients are hypromellose, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, talc and magnesium stearate. The film-coat inactive ingredients are hypromellose, titanium dioxide, polyethylene glycol 4000, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow."
},
{
"NDCCode": "46708-556-45",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (46708-556-45) ",
"NDC11Code": "46708-0556-45",
"ProductNDC": "46708-556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213682",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "24; 26",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241104",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablet is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablet reduce NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. The active pharmaceutical ingredient used to manufacture sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5.The complexis chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)-water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is: Sacubitril and valsartan is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The inactive ingredients are hypromellose, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, talc and magnesium stearate. The film-coat inactive ingredients are hypromellose, titanium dioxide, polyethylene glycol 4000, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow."
},
{
"NDCCode": "71610-556-45",
"PackageDescription": "45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-556-45) ",
"NDC11Code": "71610-0556-45",
"ProductNDC": "71610-556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076704",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2022-03-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220308",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.",
"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, practically odorless, 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: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "72189-556-45",
"PackageDescription": "45 TABLET in 1 BOTTLE (72189-556-45) ",
"NDC11Code": "72189-0556-45",
"ProductNDC": "72189-556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213794",
"LabelerName": "Direct_Rx",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240611",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.",
"Description": "Ibuprofen tablets USP contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white to off-white, crystalline powder with a melting point of 74 to 77°C and is very soluble in alcohol, in methanol, in acetone and in chloroform, slightly soluble in ethyl acetate, practically insoluble in water. The structural formula is represented below: [chemical Structure]. Ibuprofen tablets USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, povidone, stearic acid, talc and titanium dioxide."
},
{
"NDCCode": "62332-556-10",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (62332-556-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "62332-0556-10",
"ProductNDC": "62332-556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213682",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "24; 26",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241104",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablet is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablet reduce NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. The active pharmaceutical ingredient used to manufacture sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5.The complexis chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)-water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is: Sacubitril and valsartan is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The inactive ingredients are hypromellose, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, talc and magnesium stearate. The film-coat inactive ingredients are hypromellose, titanium dioxide, polyethylene glycol 4000, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow."
},
{
"NDCCode": "62332-556-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (62332-556-60) ",
"NDC11Code": "62332-0556-60",
"ProductNDC": "62332-556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213682",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "24; 26",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241104",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablet is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablet reduce NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. The active pharmaceutical ingredient used to manufacture sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5.The complexis chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)-water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is: Sacubitril and valsartan is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The inactive ingredients are hypromellose, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, talc and magnesium stearate. The film-coat inactive ingredients are hypromellose, titanium dioxide, polyethylene glycol 4000, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow."
},
{
"NDCCode": "62332-556-91",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (62332-556-91) ",
"NDC11Code": "62332-0556-91",
"ProductNDC": "62332-556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213682",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "24; 26",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241104",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablet is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablet reduce NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. The active pharmaceutical ingredient used to manufacture sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5.The complexis chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)-water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is: Sacubitril and valsartan is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The inactive ingredients are hypromellose, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, talc and magnesium stearate. The film-coat inactive ingredients are hypromellose, titanium dioxide, polyethylene glycol 4000, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow."
},
{
"NDCCode": "62332-097-45",
"PackageDescription": "180 TABLET in 1 BOTTLE (62332-097-45) ",
"NDC11Code": "62332-0097-45",
"ProductNDC": "62332-097",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202101",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160707",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole tablets are indicated for the treatment of. Schizophrenia Irritability Associated with Autistic Disorder Treatment of Tourette’s Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as Aripiprazole Tablets, USP. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole Tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include colloidal silicon dioxide, corn starch, crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. Colorants include ferric oxide (red or yellow)."
},
{
"NDCCode": "62332-098-45",
"PackageDescription": "180 TABLET in 1 BOTTLE (62332-098-45) ",
"NDC11Code": "62332-0098-45",
"ProductNDC": "62332-098",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aripiprazole",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160707",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202101",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160707",
"SamplePackage": "N",
"IndicationAndUsage": "Aripiprazole tablets are indicated for the treatment of. Schizophrenia Irritability Associated with Autistic Disorder Treatment of Tourette’s Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as Aripiprazole Tablets, USP. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole Tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include colloidal silicon dioxide, corn starch, crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. Colorants include ferric oxide (red or yellow)."
},
{
"NDCCode": "62332-465-45",
"PackageDescription": "1 TUBE in 1 CARTON (62332-465-45) / 45 g in 1 TUBE",
"NDC11Code": "62332-0465-45",
"ProductNDC": "62332-465",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190312",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211800",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190312",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol Propionate Ointment USP, 0.05% is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
"Description": "Clobetasol Propionate Ointment USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum."
},
{
"NDCCode": "62332-547-45",
"PackageDescription": "1 TUBE in 1 CARTON (62332-547-45) / 45 g in 1 TUBE",
"NDC11Code": "62332-0547-45",
"ProductNDC": "62332-547",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213291",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200131",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate cream, USP is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
"Description": "Clobetasol Propionate Cream USP, 0.05% contain the active compound clobetasol propionate, USP a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate, USP is Pregna-1,4-diene-3,20-dione, 21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-, (11β,16β), and it has the following structural formula. Clobetasol propionate, USP has the molecular formula C25H32ClFO5 and a molecular weight of 466.97. It is a white to almost white crystalline powder insoluble in water. Clobetasol Propionate Cream USP, 0.05% contains clobetasol propionate, USP 0.5 mg/g in a cream base composed of anhydrous citric acid, cetyl alcohol, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH."
},
{
"NDCCode": "62332-549-45",
"PackageDescription": "1 TUBE in 1 CARTON (62332-549-45) / 45 g in 1 TUBE",
"NDC11Code": "62332-0549-45",
"ProductNDC": "62332-549",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene",
"NonProprietaryName": "Adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213508",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "ADAPALENE",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2024-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200622",
"SamplePackage": "Y",
"IndicationAndUsage": "Adapalene gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.",
"Description": "Adapalene Gel USP, 0.3% contains adapalene USP, 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbopol 980, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene, USP is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene, USP is represented by the following structural formula."
},
{
"NDCCode": "62332-549-46",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (62332-549-46) / 45 g in 1 BOTTLE, PUMP",
"NDC11Code": "62332-0549-46",
"ProductNDC": "62332-549",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene",
"NonProprietaryName": "Adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213508",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "ADAPALENE",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2024-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200622",
"SamplePackage": "Y",
"IndicationAndUsage": "Adapalene gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.",
"Description": "Adapalene Gel USP, 0.3% contains adapalene USP, 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbopol 980, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene, USP is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene, USP is represented by the following structural formula."
},
{
"NDCCode": "62332-557-45",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (62332-557-45) ",
"NDC11Code": "62332-0557-45",
"ProductNDC": "62332-557",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213682",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "49; 51",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241104",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablet is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablet reduce NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. The active pharmaceutical ingredient used to manufacture sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5.The complexis chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)-water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is: Sacubitril and valsartan is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The inactive ingredients are hypromellose, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, talc and magnesium stearate. The film-coat inactive ingredients are hypromellose, titanium dioxide, polyethylene glycol 4000, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow."
},
{
"NDCCode": "62332-558-45",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (62332-558-45) ",
"NDC11Code": "62332-0558-45",
"ProductNDC": "62332-558",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213682",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "SACUBITRIL; VALSARTAN",
"StrengthNumber": "97; 103",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241104",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablet is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablet reduce NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. The active pharmaceutical ingredient used to manufacture sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5.The complexis chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)-water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is: Sacubitril and valsartan is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The inactive ingredients are hypromellose, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, talc and magnesium stearate. The film-coat inactive ingredients are hypromellose, titanium dioxide, polyethylene glycol 4000, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow."
},
{
"NDCCode": "62332-630-45",
"PackageDescription": "1 TUBE in 1 CARTON (62332-630-45) / 45 g in 1 TUBE",
"NDC11Code": "62332-0630-45",
"ProductNDC": "62332-630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210906",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212646",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Active",
"LastUpdate": "2024-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210906",
"SamplePackage": "N",
"IndicationAndUsage": "Metronidazole gel, 1% is nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea.",
"Description": "Metronidazole gel USP, 1% is a nitroimidazole for topical use. Metronidazole gel USP, 1% is a clear, colorless to pale yellow, aqueous gel. Each gram contains 10 mg of metronidazole. Chemically, metronidazole is 2-methyl-5-nitro-1 H-imidazole-1-ethanol. The molecular formula for metronidazole is C6H9N3O3. It has the following structural formula. Metronidazole has a molecular weight of 171.16. It is a white to pale yellow crystalline powder. It is slightly soluble in alcohol and has solubility in water of 10 mg/mL at 20˚C. Metronidazole belongs to the nitroimidazole class of compounds. The inactive ingredients are betadex, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben and purified water."
},
{
"NDCCode": "62332-636-45",
"PackageDescription": "180 CAPSULE in 1 BOTTLE (62332-636-45) ",
"NDC11Code": "62332-0636-45",
"ProductNDC": "62332-636",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran Etexilate",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215233",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251008",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4) For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is off-white to yellowish powder. It is freely soluble in methanol and ethanol, practically insoluble in acetone, ethyl acetate and water. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: hydroxypropyl cellulose, hypromellose phthalate, pelletized tartaric acid, talc. The capsule shell is composed of carrageenan, hypromellose, potassium chloride and titanium dioxide. Additionally, 110 mg and 150 mg capsule shell also contains FD&C Blue No. 2. The empty hard hypromellose capsule shells are printed with edible black ink containing iron oxide black, potassium hydroxide and shellac."
},
{
"NDCCode": "62332-662-45",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (62332-662-45) / 45 g in 1 BOTTLE, PUMP",
"NDC11Code": "62332-0662-45",
"ProductNDC": "62332-662",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adapalene And Benzoyl Peroxide",
"NonProprietaryName": "Adapalene And Benzoyl Peroxide Topical",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214185",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "ADAPALENE; BENZOYL PEROXIDE",
"StrengthNumber": "3; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-05-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220810",
"SamplePackage": "N",
"IndicationAndUsage": "Adapalene and benzoyl peroxide topical gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.",
"Description": "Adapalene and benzoyl peroxide topical gel USP, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene:. Molecular formula: C28H28O3 Molecular weight: 412.5. Benzoyl peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula:. Benzoyl Peroxide:. Molecular formula: C14H10O4 Molecular weight: 242.23. Adapalene and benzoyl peroxide topical gel USP contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water and sorbitan oleate."
},
{
"NDCCode": "62332-679-45",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (62332-679-45) ",
"NDC11Code": "62332-0679-45",
"ProductNDC": "62332-679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ivabradine",
"NonProprietaryName": "Ivabradine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215238",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "IVABRADINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241220",
"SamplePackage": "N",
"IndicationAndUsage": "Ivabradine tablets are hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: : 1 To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. (1.1) .",
"Description": "Ivabradine tablets contain ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. The chemical name for ivabradine hydrochloride is 3-(3-{[((7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl] methyl amino} propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one, hydrochloride. The molecular formula is C27H36N2O5·HCl, and the molecular weight (free base + HCl) is 505.1 (468.6 + 36.5). The chemical structure of ivabradine is shown in Figure 1. Figure 1. Chemical Structure of IvabradineIvabradine tablets are formulated as light salmon to salmon colored, film-coated tablets for oral administration in strengths of 5 mg and 7.5 mg of ivabradine, equivalent to 5.39 mg and 8.09 mg of ivabradine hydrochloride respectively. The tablets contain the following inactive ingredients: maltodextrin, lactose anhydrous, butylated hydroxyanisole, butylated hydroxytoluene, hypromellose 2910, colloidal silicon dioxide, magnesium stearate, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 6000, iron oxide yellow and iron oxide red."
},
{
"NDCCode": "62332-680-45",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (62332-680-45) ",
"NDC11Code": "62332-0680-45",
"ProductNDC": "62332-680",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ivabradine",
"NonProprietaryName": "Ivabradine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215238",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "IVABRADINE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241220",
"SamplePackage": "N",
"IndicationAndUsage": "Ivabradine tablets are hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: : 1 To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. (1.1) .",
"Description": "Ivabradine tablets contain ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. The chemical name for ivabradine hydrochloride is 3-(3-{[((7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl] methyl amino} propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one, hydrochloride. The molecular formula is C27H36N2O5·HCl, and the molecular weight (free base + HCl) is 505.1 (468.6 + 36.5). The chemical structure of ivabradine is shown in Figure 1. Figure 1. Chemical Structure of IvabradineIvabradine tablets are formulated as light salmon to salmon colored, film-coated tablets for oral administration in strengths of 5 mg and 7.5 mg of ivabradine, equivalent to 5.39 mg and 8.09 mg of ivabradine hydrochloride respectively. The tablets contain the following inactive ingredients: maltodextrin, lactose anhydrous, butylated hydroxyanisole, butylated hydroxytoluene, hypromellose 2910, colloidal silicon dioxide, magnesium stearate, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 6000, iron oxide yellow and iron oxide red."
},
{
"NDCCode": "62332-683-45",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (62332-683-45) ",
"NDC11Code": "62332-0683-45",
"ProductNDC": "62332-683",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivaroxaban",
"NonProprietaryName": "Rivaroxaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210301",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "RIVAROXABAN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250514",
"SamplePackage": "N",
"IndicationAndUsage": "Rivaroxaban tablet is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1) for treatment of deep vein thrombosis (DVT) (1.2) for treatment of pulmonary embolism (PE) (1.3) for reduction in the risk of recurrence of DVT or PE (1.4) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5) for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8) for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9). for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).",
"Description": "Rivaroxaban, USP, a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban, USP is C19H18ClN3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is an white to yellowish powder. Rivaroxaban, USP is soluble in dimethyl sulfoxide, practically insoluble to very slightly soluble in acetone and water. Each rivaroxaban tablet, USP contains 2.5 mg, 10 mg, 15 mg or 20 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban 2.5 mg tablet is Opadry® Yellow containing D&C yellow #10 aluminium lake, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol 6000, titanium dioxide, and for rivaroxaban 10 mg tablet is Opadry® Pink containing hypromellose, iron oxide red, polyethylene glycol 6000, talc, titanium dioxide, and for rivaroxaban 15 mg tablet and 20 mg tablet is Opadry® Brown containing hypromellose, iron oxide black, iron oxide red, polyethylene glycol 8000, and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "62332-807-45",
"PackageDescription": "1 TUBE in 1 CARTON (62332-807-45) / 45 g in 1 TUBE",
"NDC11Code": "62332-0807-45",
"ProductNDC": "62332-807",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tretinoin",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217804",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "TRETINOIN",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2024-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240501",
"SamplePackage": "N",
"IndicationAndUsage": "Tretinoin Cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.",
"Description": "Tretinoin Cream USP, 0.1%, containing tretinoin USP, is used for the topical treatment of acne vulgaris. Tretinoin Cream contains tretinoin USP in 0.1% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure."
},
{
"NDCCode": "62332-808-45",
"PackageDescription": "1 TUBE in 1 CARTON (62332-808-45) / 45 g in 1 TUBE",
"NDC11Code": "62332-0808-45",
"ProductNDC": "62332-808",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tretinoin",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214590",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260611",
"SamplePackage": "N",
"IndicationAndUsage": "Tretinoin Cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.",
"Description": "Tretinoin Cream USP, 0.05%, containing tretinoin USP, is used for the topical treatment of acne vulgaris. Tretinoin Cream contains tretinoin USP in 0.05% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure."
},
{
"NDCCode": "62332-809-45",
"PackageDescription": "1 TUBE in 1 CARTON (62332-809-45) / 45 g in 1 TUBE",
"NDC11Code": "62332-0809-45",
"ProductNDC": "62332-809",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tretinoin",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218399",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250816",
"SamplePackage": "N",
"IndicationAndUsage": "Tretinoin Cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.",
"Description": "Tretinoin Cream USP, 0.025%, containing tretinoin USP, is used for the topical treatment of acne vulgaris. Tretinoin Cream contains tretinoin USP in 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure."
},
{
"NDCCode": "65862-556-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-556-01) ",
"NDC11Code": "65862-0556-01",
"ProductNDC": "65862-556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202261",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121119",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use : 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. , 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]. , 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)]. .",
"Description": "Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. Minocycline hydrochloride extended-release tablets USP for oral administration contain minocycline hydrochloride, USP equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg of minocycline. In addition, 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, titanium dioxide, and triacetin. : 1 The 45 mg extended-release tablets also contain iron oxide black. , 2 The 55 mg extended-release tablets also contain FD&C Red # 40/Allura Red AC aluminum lake and polyethylene glycol. , 3 The 65 mg extended-release tablets also contain D&C Yellow #10 aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake, FD&C Blue #2/Indigo caramine aluminum lake, and polyethylene glycol. , 4 The 80 mg extended-release tablets also contain FD&C Blue #2 indigo caramine aluminum lake, FD&C Red # 40/Allura Red AC aluminum lake, FD&C Yellow #6/Sunset yellow FCF aluminum lake and polyethylene glycol. , 5 The 90 mg extended-release tablets also contain iron oxide yellow and polyethylene glycol. , 6 The 105 mg extended-release tablets also contain D&C Red #27/Phloxine aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake and polyethylene glycol. , 7 The 115 mg extended-release tablets also contain D&C Yellow #10 aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake and FD&C Blue #2/Indigo caramine aluminum lake. , 8 The 135 mg extended-release tablets also contain iron oxide red and polyethylene glycol. ."
},
{
"NDCCode": "65862-556-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-556-30) ",
"NDC11Code": "65862-0556-30",
"ProductNDC": "65862-556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202261",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121119",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use : 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. , 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]. , 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)]. .",
"Description": "Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. Minocycline hydrochloride extended-release tablets USP for oral administration contain minocycline hydrochloride, USP equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg of minocycline. In addition, 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, titanium dioxide, and triacetin. : 1 The 45 mg extended-release tablets also contain iron oxide black. , 2 The 55 mg extended-release tablets also contain FD&C Red # 40/Allura Red AC aluminum lake and polyethylene glycol. , 3 The 65 mg extended-release tablets also contain D&C Yellow #10 aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake, FD&C Blue #2/Indigo caramine aluminum lake, and polyethylene glycol. , 4 The 80 mg extended-release tablets also contain FD&C Blue #2 indigo caramine aluminum lake, FD&C Red # 40/Allura Red AC aluminum lake, FD&C Yellow #6/Sunset yellow FCF aluminum lake and polyethylene glycol. , 5 The 90 mg extended-release tablets also contain iron oxide yellow and polyethylene glycol. , 6 The 105 mg extended-release tablets also contain D&C Red #27/Phloxine aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake and polyethylene glycol. , 7 The 115 mg extended-release tablets also contain D&C Yellow #10 aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake and FD&C Blue #2/Indigo caramine aluminum lake. , 8 The 135 mg extended-release tablets also contain iron oxide red and polyethylene glycol. ."
},
{
"NDCCode": "65862-556-99",
"PackageDescription": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-556-99) ",
"NDC11Code": "65862-0556-99",
"ProductNDC": "65862-556",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202261",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121119",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use : 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. , 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]. , 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)]. .",
"Description": "Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. Minocycline hydrochloride extended-release tablets USP for oral administration contain minocycline hydrochloride, USP equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg of minocycline. In addition, 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, titanium dioxide, and triacetin. : 1 The 45 mg extended-release tablets also contain iron oxide black. , 2 The 55 mg extended-release tablets also contain FD&C Red # 40/Allura Red AC aluminum lake and polyethylene glycol. , 3 The 65 mg extended-release tablets also contain D&C Yellow #10 aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake, FD&C Blue #2/Indigo caramine aluminum lake, and polyethylene glycol. , 4 The 80 mg extended-release tablets also contain FD&C Blue #2 indigo caramine aluminum lake, FD&C Red # 40/Allura Red AC aluminum lake, FD&C Yellow #6/Sunset yellow FCF aluminum lake and polyethylene glycol. , 5 The 90 mg extended-release tablets also contain iron oxide yellow and polyethylene glycol. , 6 The 105 mg extended-release tablets also contain D&C Red #27/Phloxine aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake and polyethylene glycol. , 7 The 115 mg extended-release tablets also contain D&C Yellow #10 aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake and FD&C Blue #2/Indigo caramine aluminum lake. , 8 The 135 mg extended-release tablets also contain iron oxide red and polyethylene glycol. ."
},
{
"NDCCode": "62332-071-01",
"PackageDescription": "1 VIAL in 1 CARTON (62332-071-01) / 10 mL in 1 VIAL",
"NDC11Code": "62332-0071-01",
"ProductNDC": "62332-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium Injection",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219230",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250331",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium for injection is indicated for treatment of: 1 gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults., 2 pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.",
"Description": "The active ingredient in pantoprazole sodium for injection (pantoprazole sodium), a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is. Pantoprazole sodium is a white or almost white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The reconstituted solution of pantoprazole sodium for injection is in the pH range of 9.0 to 10.5. Pantoprazole sodium for injection is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium), edetate disodium (1 mg), and sodium hydroxide to adjust pH."
},
{
"NDCCode": "62332-071-10",
"PackageDescription": "10 VIAL in 1 CARTON (62332-071-10) / 10 mL in 1 VIAL",
"NDC11Code": "62332-0071-10",
"ProductNDC": "62332-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium Injection",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219230",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250331",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium for injection is indicated for treatment of: 1 gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults., 2 pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.",
"Description": "The active ingredient in pantoprazole sodium for injection (pantoprazole sodium), a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is. Pantoprazole sodium is a white or almost white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The reconstituted solution of pantoprazole sodium for injection is in the pH range of 9.0 to 10.5. Pantoprazole sodium for injection is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium), edetate disodium (1 mg), and sodium hydroxide to adjust pH."
},
{
"NDCCode": "62332-071-25",
"PackageDescription": "25 VIAL in 1 CARTON (62332-071-25) / 10 mL in 1 VIAL",
"NDC11Code": "62332-0071-25",
"ProductNDC": "62332-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium Injection",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219230",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250331",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium for injection is indicated for treatment of: 1 gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults., 2 pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.",
"Description": "The active ingredient in pantoprazole sodium for injection (pantoprazole sodium), a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is. Pantoprazole sodium is a white or almost white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The reconstituted solution of pantoprazole sodium for injection is in the pH range of 9.0 to 10.5. Pantoprazole sodium for injection is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium), edetate disodium (1 mg), and sodium hydroxide to adjust pH."
}
]
}
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<Description>Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. The active pharmaceutical ingredient used to manufacture sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5.The complexis chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)-water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is: Sacubitril and valsartan is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The inactive ingredients are hypromellose, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, talc and magnesium stearate. The film-coat inactive ingredients are hypromellose, titanium dioxide, polyethylene glycol 4000, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow.</Description>
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<Description>Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. The active pharmaceutical ingredient used to manufacture sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5.The complexis chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)-water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is: Sacubitril and valsartan is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The inactive ingredients are hypromellose, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, talc and magnesium stearate. The film-coat inactive ingredients are hypromellose, titanium dioxide, polyethylene glycol 4000, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow.</Description>
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<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
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<LastUpdate>2022-03-12</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.</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, practically odorless, 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: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake.</Description>
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<PackageDescription>45 TABLET in 1 BOTTLE (72189-556-45) </PackageDescription>
<NDC11Code>72189-0556-45</NDC11Code>
<ProductNDC>72189-556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
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<StartMarketingDate>20240611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-06</LastUpdate>
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<IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
<Description>Ibuprofen tablets USP contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white to off-white, crystalline powder with a melting point of 74 to 77°C and is very soluble in alcohol, in methanol, in acetone and in chloroform, slightly soluble in ethyl acetate, practically insoluble in water. The structural formula is represented below: [chemical Structure]. Ibuprofen tablets USP, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, povidone, stearic acid, talc and titanium dioxide.</Description>
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<IndicationAndUsage>Sacubitril and valsartan tablet is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablet reduce NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. The active pharmaceutical ingredient used to manufacture sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5.The complexis chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)-water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is: Sacubitril and valsartan is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The inactive ingredients are hypromellose, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, talc and magnesium stearate. The film-coat inactive ingredients are hypromellose, titanium dioxide, polyethylene glycol 4000, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow.</Description>
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<IndicationAndUsage>Sacubitril and valsartan tablet is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablet reduce NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. The active pharmaceutical ingredient used to manufacture sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5.The complexis chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)-water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is: Sacubitril and valsartan is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The inactive ingredients are hypromellose, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, talc and magnesium stearate. The film-coat inactive ingredients are hypromellose, titanium dioxide, polyethylene glycol 4000, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow.</Description>
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<ApplicationNumber>ANDA213682</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
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<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
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<LastUpdate>2024-11-05</LastUpdate>
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<IndicationAndUsage>Sacubitril and valsartan tablet is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablet reduce NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. The active pharmaceutical ingredient used to manufacture sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5.The complexis chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)-water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is: Sacubitril and valsartan is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The inactive ingredients are hypromellose, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, talc and magnesium stearate. The film-coat inactive ingredients are hypromellose, titanium dioxide, polyethylene glycol 4000, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow.</Description>
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<PackageDescription>180 TABLET in 1 BOTTLE (62332-097-45) </PackageDescription>
<NDC11Code>62332-0097-45</NDC11Code>
<ProductNDC>62332-097</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202101</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-28</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole tablets are indicated for the treatment of. Schizophrenia Irritability Associated with Autistic Disorder Treatment of Tourette’s Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as Aripiprazole Tablets, USP. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole Tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include colloidal silicon dioxide, corn starch, crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. Colorants include ferric oxide (red or yellow).</Description>
</NDC>
<NDC>
<NDCCode>62332-098-45</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (62332-098-45) </PackageDescription>
<NDC11Code>62332-0098-45</NDC11Code>
<ProductNDC>62332-098</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aripiprazole</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202101</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aripiprazole tablets are indicated for the treatment of. Schizophrenia Irritability Associated with Autistic Disorder Treatment of Tourette’s Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as Aripiprazole Tablets, USP. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. Aripiprazole Tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include colloidal silicon dioxide, corn starch, crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. Colorants include ferric oxide (red or yellow).</Description>
</NDC>
<NDC>
<NDCCode>62332-465-45</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62332-465-45) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>62332-0465-45</NDC11Code>
<ProductNDC>62332-465</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190312</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211800</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol Propionate Ointment USP, 0.05% is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol Propionate Ointment USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula. Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>62332-547-45</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62332-547-45) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>62332-0547-45</NDC11Code>
<ProductNDC>62332-547</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213291</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate cream, USP is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol Propionate Cream USP, 0.05% contain the active compound clobetasol propionate, USP a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate, USP is Pregna-1,4-diene-3,20-dione, 21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-, (11β,16β), and it has the following structural formula. Clobetasol propionate, USP has the molecular formula C25H32ClFO5 and a molecular weight of 466.97. It is a white to almost white crystalline powder insoluble in water. Clobetasol Propionate Cream USP, 0.05% contains clobetasol propionate, USP 0.5 mg/g in a cream base composed of anhydrous citric acid, cetyl alcohol, glycol stearate, lanolin oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>62332-549-45</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62332-549-45) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>62332-0549-45</NDC11Code>
<ProductNDC>62332-549</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adapalene</ProprietaryName>
<NonProprietaryName>Adapalene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213508</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ADAPALENE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200622</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Adapalene gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.</IndicationAndUsage>
<Description>Adapalene Gel USP, 0.3% contains adapalene USP, 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbopol 980, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene, USP is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene, USP is represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>62332-549-46</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (62332-549-46) / 45 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>62332-0549-46</NDC11Code>
<ProductNDC>62332-549</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adapalene</ProprietaryName>
<NonProprietaryName>Adapalene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213508</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ADAPALENE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200622</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Adapalene gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.</IndicationAndUsage>
<Description>Adapalene Gel USP, 0.3% contains adapalene USP, 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbopol 980, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene, USP is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene, USP is represented by the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>62332-557-45</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (62332-557-45) </PackageDescription>
<NDC11Code>62332-0557-45</NDC11Code>
<ProductNDC>62332-557</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213682</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>49; 51</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sacubitril and valsartan tablet is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablet reduce NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. The active pharmaceutical ingredient used to manufacture sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5.The complexis chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)-water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is: Sacubitril and valsartan is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The inactive ingredients are hypromellose, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, talc and magnesium stearate. The film-coat inactive ingredients are hypromellose, titanium dioxide, polyethylene glycol 4000, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>62332-558-45</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (62332-558-45) </PackageDescription>
<NDC11Code>62332-0558-45</NDC11Code>
<ProductNDC>62332-558</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
<NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213682</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>97; 103</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sacubitril and valsartan tablet is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablet reduce NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. The active pharmaceutical ingredient used to manufacture sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5.The complexis chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)-water (1/15). Its molecular formula (hemipentahydrate) is C48H55N6O8Na3 2.5 H2O. Its molecular mass is 957.99 g/mol and its schematic structural formula is: Sacubitril and valsartan is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The inactive ingredients are hypromellose, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, talc and magnesium stearate. The film-coat inactive ingredients are hypromellose, titanium dioxide, polyethylene glycol 4000, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>62332-630-45</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62332-630-45) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>62332-0630-45</NDC11Code>
<ProductNDC>62332-630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210906</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212646</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metronidazole gel, 1% is nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea.</IndicationAndUsage>
<Description>Metronidazole gel USP, 1% is a nitroimidazole for topical use. Metronidazole gel USP, 1% is a clear, colorless to pale yellow, aqueous gel. Each gram contains 10 mg of metronidazole. Chemically, metronidazole is 2-methyl-5-nitro-1 H-imidazole-1-ethanol. The molecular formula for metronidazole is C6H9N3O3. It has the following structural formula. Metronidazole has a molecular weight of 171.16. It is a white to pale yellow crystalline powder. It is slightly soluble in alcohol and has solubility in water of 10 mg/mL at 20˚C. Metronidazole belongs to the nitroimidazole class of compounds. The inactive ingredients are betadex, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben and purified water.</Description>
</NDC>
<NDC>
<NDCCode>62332-636-45</NDCCode>
<PackageDescription>180 CAPSULE in 1 BOTTLE (62332-636-45) </PackageDescription>
<NDC11Code>62332-0636-45</NDC11Code>
<ProductNDC>62332-636</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dabigatran Etexilate</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215233</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4) For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5) To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is off-white to yellowish powder. It is freely soluble in methanol and ethanol, practically insoluble in acetone, ethyl acetate and water. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: hydroxypropyl cellulose, hypromellose phthalate, pelletized tartaric acid, talc. The capsule shell is composed of carrageenan, hypromellose, potassium chloride and titanium dioxide. Additionally, 110 mg and 150 mg capsule shell also contains FD&C Blue No. 2. The empty hard hypromellose capsule shells are printed with edible black ink containing iron oxide black, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>62332-662-45</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (62332-662-45) / 45 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>62332-0662-45</NDC11Code>
<ProductNDC>62332-662</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adapalene And Benzoyl Peroxide</ProprietaryName>
<NonProprietaryName>Adapalene And Benzoyl Peroxide Topical</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214185</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ADAPALENE; BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>3; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adapalene and benzoyl peroxide topical gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>Adapalene and benzoyl peroxide topical gel USP, 0.3%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.3% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid). It has the following structural formula:. Adapalene:. Molecular formula: C28H28O3 Molecular weight: 412.5. Benzoyl peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula:. Benzoyl Peroxide:. Molecular formula: C14H10O4 Molecular weight: 242.23. Adapalene and benzoyl peroxide topical gel USP contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water and sorbitan oleate.</Description>
</NDC>
<NDC>
<NDCCode>62332-679-45</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (62332-679-45) </PackageDescription>
<NDC11Code>62332-0679-45</NDC11Code>
<ProductNDC>62332-679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ivabradine</ProprietaryName>
<NonProprietaryName>Ivabradine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215238</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IVABRADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ivabradine tablets are hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: : 1 To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. (1.1) .</IndicationAndUsage>
<Description>Ivabradine tablets contain ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. The chemical name for ivabradine hydrochloride is 3-(3-{[((7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl] methyl amino} propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one, hydrochloride. The molecular formula is C27H36N2O5·HCl, and the molecular weight (free base + HCl) is 505.1 (468.6 + 36.5). The chemical structure of ivabradine is shown in Figure 1. Figure 1. Chemical Structure of IvabradineIvabradine tablets are formulated as light salmon to salmon colored, film-coated tablets for oral administration in strengths of 5 mg and 7.5 mg of ivabradine, equivalent to 5.39 mg and 8.09 mg of ivabradine hydrochloride respectively. The tablets contain the following inactive ingredients: maltodextrin, lactose anhydrous, butylated hydroxyanisole, butylated hydroxytoluene, hypromellose 2910, colloidal silicon dioxide, magnesium stearate, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 6000, iron oxide yellow and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>62332-680-45</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (62332-680-45) </PackageDescription>
<NDC11Code>62332-0680-45</NDC11Code>
<ProductNDC>62332-680</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ivabradine</ProprietaryName>
<NonProprietaryName>Ivabradine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215238</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IVABRADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ivabradine tablets are hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: : 1 To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. (1.1) .</IndicationAndUsage>
<Description>Ivabradine tablets contain ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. The chemical name for ivabradine hydrochloride is 3-(3-{[((7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl] methyl amino} propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one, hydrochloride. The molecular formula is C27H36N2O5·HCl, and the molecular weight (free base + HCl) is 505.1 (468.6 + 36.5). The chemical structure of ivabradine is shown in Figure 1. Figure 1. Chemical Structure of IvabradineIvabradine tablets are formulated as light salmon to salmon colored, film-coated tablets for oral administration in strengths of 5 mg and 7.5 mg of ivabradine, equivalent to 5.39 mg and 8.09 mg of ivabradine hydrochloride respectively. The tablets contain the following inactive ingredients: maltodextrin, lactose anhydrous, butylated hydroxyanisole, butylated hydroxytoluene, hypromellose 2910, colloidal silicon dioxide, magnesium stearate, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 6000, iron oxide yellow and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>62332-683-45</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (62332-683-45) </PackageDescription>
<NDC11Code>62332-0683-45</NDC11Code>
<ProductNDC>62332-683</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivaroxaban</ProprietaryName>
<NonProprietaryName>Rivaroxaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210301</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>RIVAROXABAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivaroxaban tablet is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation (1.1) for treatment of deep vein thrombosis (DVT) (1.2) for treatment of pulmonary embolism (PE) (1.3) for reduction in the risk of recurrence of DVT or PE (1.4) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery (1.5) for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients (1.6) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) (1.7) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD (1.8) for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years (1.9). for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure (1.10).</IndicationAndUsage>
<Description>Rivaroxaban, USP, a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban, USP is C19H18ClN3O5S and the molecular weight is 435.88. The structural formula is. Rivaroxaban, USP is a pure (S)-enantiomer. It is an white to yellowish powder. Rivaroxaban, USP is soluble in dimethyl sulfoxide, practically insoluble to very slightly soluble in acetone and water. Each rivaroxaban tablet, USP contains 2.5 mg, 10 mg, 15 mg or 20 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban 2.5 mg tablet is Opadry® Yellow containing D&C yellow #10 aluminium lake, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol 6000, titanium dioxide, and for rivaroxaban 10 mg tablet is Opadry® Pink containing hypromellose, iron oxide red, polyethylene glycol 6000, talc, titanium dioxide, and for rivaroxaban 15 mg tablet and 20 mg tablet is Opadry® Brown containing hypromellose, iron oxide black, iron oxide red, polyethylene glycol 8000, and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>62332-807-45</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62332-807-45) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>62332-0807-45</NDC11Code>
<ProductNDC>62332-807</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tretinoin</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217804</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tretinoin Cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.</IndicationAndUsage>
<Description>Tretinoin Cream USP, 0.1%, containing tretinoin USP, is used for the topical treatment of acne vulgaris. Tretinoin Cream contains tretinoin USP in 0.1% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure.</Description>
</NDC>
<NDC>
<NDCCode>62332-808-45</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62332-808-45) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>62332-0808-45</NDC11Code>
<ProductNDC>62332-808</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tretinoin</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214590</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260611</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tretinoin Cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.</IndicationAndUsage>
<Description>Tretinoin Cream USP, 0.05%, containing tretinoin USP, is used for the topical treatment of acne vulgaris. Tretinoin Cream contains tretinoin USP in 0.05% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure.</Description>
</NDC>
<NDC>
<NDCCode>62332-809-45</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62332-809-45) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>62332-0809-45</NDC11Code>
<ProductNDC>62332-809</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tretinoin</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218399</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tretinoin Cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.</IndicationAndUsage>
<Description>Tretinoin Cream USP, 0.025%, containing tretinoin USP, is used for the topical treatment of acne vulgaris. Tretinoin Cream contains tretinoin USP in 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans-retinoic acid and has the following structure.</Description>
</NDC>
<NDC>
<NDCCode>65862-556-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-556-01) </PackageDescription>
<NDC11Code>65862-0556-01</NDC11Code>
<ProductNDC>65862-556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202261</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use : 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. , 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]. , 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)]. .</IndicationAndUsage>
<Description>Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. Minocycline hydrochloride extended-release tablets USP for oral administration contain minocycline hydrochloride, USP equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg of minocycline. In addition, 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, titanium dioxide, and triacetin. : 1 The 45 mg extended-release tablets also contain iron oxide black. , 2 The 55 mg extended-release tablets also contain FD&C Red # 40/Allura Red AC aluminum lake and polyethylene glycol. , 3 The 65 mg extended-release tablets also contain D&C Yellow #10 aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake, FD&C Blue #2/Indigo caramine aluminum lake, and polyethylene glycol. , 4 The 80 mg extended-release tablets also contain FD&C Blue #2 indigo caramine aluminum lake, FD&C Red # 40/Allura Red AC aluminum lake, FD&C Yellow #6/Sunset yellow FCF aluminum lake and polyethylene glycol. , 5 The 90 mg extended-release tablets also contain iron oxide yellow and polyethylene glycol. , 6 The 105 mg extended-release tablets also contain D&C Red #27/Phloxine aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake and polyethylene glycol. , 7 The 115 mg extended-release tablets also contain D&C Yellow #10 aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake and FD&C Blue #2/Indigo caramine aluminum lake. , 8 The 135 mg extended-release tablets also contain iron oxide red and polyethylene glycol. .</Description>
</NDC>
<NDC>
<NDCCode>65862-556-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-556-30) </PackageDescription>
<NDC11Code>65862-0556-30</NDC11Code>
<ProductNDC>65862-556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202261</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use : 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. , 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]. , 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)]. .</IndicationAndUsage>
<Description>Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. Minocycline hydrochloride extended-release tablets USP for oral administration contain minocycline hydrochloride, USP equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg of minocycline. In addition, 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, titanium dioxide, and triacetin. : 1 The 45 mg extended-release tablets also contain iron oxide black. , 2 The 55 mg extended-release tablets also contain FD&C Red # 40/Allura Red AC aluminum lake and polyethylene glycol. , 3 The 65 mg extended-release tablets also contain D&C Yellow #10 aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake, FD&C Blue #2/Indigo caramine aluminum lake, and polyethylene glycol. , 4 The 80 mg extended-release tablets also contain FD&C Blue #2 indigo caramine aluminum lake, FD&C Red # 40/Allura Red AC aluminum lake, FD&C Yellow #6/Sunset yellow FCF aluminum lake and polyethylene glycol. , 5 The 90 mg extended-release tablets also contain iron oxide yellow and polyethylene glycol. , 6 The 105 mg extended-release tablets also contain D&C Red #27/Phloxine aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake and polyethylene glycol. , 7 The 115 mg extended-release tablets also contain D&C Yellow #10 aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake and FD&C Blue #2/Indigo caramine aluminum lake. , 8 The 135 mg extended-release tablets also contain iron oxide red and polyethylene glycol. .</Description>
</NDC>
<NDC>
<NDCCode>65862-556-99</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-556-99) </PackageDescription>
<NDC11Code>65862-0556-99</NDC11Code>
<ProductNDC>65862-556</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202261</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minocycline hydrochloride extended-release tablets are indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use : 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. , 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies (14)]. , 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions (5.12)]. .</IndicationAndUsage>
<Description>Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. Minocycline hydrochloride extended-release tablets USP for oral administration contain minocycline hydrochloride, USP equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg of minocycline. In addition, 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, titanium dioxide, and triacetin. : 1 The 45 mg extended-release tablets also contain iron oxide black. , 2 The 55 mg extended-release tablets also contain FD&C Red # 40/Allura Red AC aluminum lake and polyethylene glycol. , 3 The 65 mg extended-release tablets also contain D&C Yellow #10 aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake, FD&C Blue #2/Indigo caramine aluminum lake, and polyethylene glycol. , 4 The 80 mg extended-release tablets also contain FD&C Blue #2 indigo caramine aluminum lake, FD&C Red # 40/Allura Red AC aluminum lake, FD&C Yellow #6/Sunset yellow FCF aluminum lake and polyethylene glycol. , 5 The 90 mg extended-release tablets also contain iron oxide yellow and polyethylene glycol. , 6 The 105 mg extended-release tablets also contain D&C Red #27/Phloxine aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake and polyethylene glycol. , 7 The 115 mg extended-release tablets also contain D&C Yellow #10 aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake and FD&C Blue #2/Indigo caramine aluminum lake. , 8 The 135 mg extended-release tablets also contain iron oxide red and polyethylene glycol. .</Description>
</NDC>
<NDC>
<NDCCode>62332-071-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (62332-071-01) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>62332-0071-01</NDC11Code>
<ProductNDC>62332-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium Injection</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219230</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium for injection is indicated for treatment of: 1 gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults., 2 pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium for injection (pantoprazole sodium), a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is. Pantoprazole sodium is a white or almost white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The reconstituted solution of pantoprazole sodium for injection is in the pH range of 9.0 to 10.5. Pantoprazole sodium for injection is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium), edetate disodium (1 mg), and sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>62332-071-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (62332-071-10) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>62332-0071-10</NDC11Code>
<ProductNDC>62332-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium Injection</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219230</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium for injection is indicated for treatment of: 1 gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults., 2 pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium for injection (pantoprazole sodium), a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is. Pantoprazole sodium is a white or almost white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The reconstituted solution of pantoprazole sodium for injection is in the pH range of 9.0 to 10.5. Pantoprazole sodium for injection is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium), edetate disodium (1 mg), and sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>62332-071-25</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (62332-071-25) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>62332-0071-25</NDC11Code>
<ProductNDC>62332-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium Injection</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250331</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219230</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium for injection is indicated for treatment of: 1 gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults., 2 pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium for injection (pantoprazole sodium), a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is. Pantoprazole sodium is a white or almost white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The reconstituted solution of pantoprazole sodium for injection is in the pH range of 9.0 to 10.5. Pantoprazole sodium for injection is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium), edetate disodium (1 mg), and sodium hydroxide to adjust pH.</Description>
</NDC>
</NDCList>