{
"NDC": [
{
"NDCCode": "67877-732-97",
"PackageDescription": "465 mL in 1 BOTTLE (67877-732-97) ",
"NDC11Code": "67877-0732-97",
"ProductNDC": "67877-732",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide Oral Solution",
"NonProprietaryName": "Lacosamide Oral Solution",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20220520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214672",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220520",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide oral solution is indicated for: 1 Treatment of partial-onset seizures in patients 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2) .",
"Description": "The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3and its molecular weight is 250.30. The chemical structure is:Lacosamide, USP is a white to light yellow powder. It is freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile, and practically insoluble in heptane."
},
{
"NDCCode": "67877-732-95",
"PackageDescription": "200 mL in 1 BOTTLE (67877-732-95) ",
"NDC11Code": "67877-0732-95",
"ProductNDC": "67877-732",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide Oral Solution",
"NonProprietaryName": "Lacosamide Oral Solution",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20220520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214672",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220520",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide oral solution is indicated for: 1 Treatment of partial-onset seizures in patients 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2) .",
"Description": "The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3and its molecular weight is 250.30. The chemical structure is:Lacosamide, USP is a white to light yellow powder. It is freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile, and practically insoluble in heptane."
},
{
"NDCCode": "67877-276-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (67877-276-05) ",
"NDC11Code": "67877-0276-05",
"ProductNDC": "67877-276",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203632",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240516",
"SamplePackage": "N",
"IndicationAndUsage": "Clopidogrel tablets is a P2Y12 platelet inhibitor indicated for: Acute coronary syndrome - For patients with non-ST-segment elevation ACS(unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1) - For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets has been shown to reduce the rate of MI and stroke. (1.1) Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets has been shown to reduce the rate of MI and stroke. (1.2).",
"Description": "Clopidogrel is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2- chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16CINO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows:. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration is provided as either pink colored, biconvex, round shaped, beveled edge, film coated tablets printed \"CL 75\" on one side and plain on other side containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains colloidal silicon dioxide, hydrogenated castor oil, low substituted hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and polyethylene glycol 6000 as inactive ingredients. The pink film coating contains hypromellose 2910, lactose monohydrate, red iron oxide, titanium dioxide, and triacetin. The imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac. FDA approved dissolution test and specification differ from USP."
},
{
"NDCCode": "67877-276-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (67877-276-30) ",
"NDC11Code": "67877-0276-30",
"ProductNDC": "67877-276",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203632",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240516",
"SamplePackage": "N",
"IndicationAndUsage": "Clopidogrel tablets is a P2Y12 platelet inhibitor indicated for: Acute coronary syndrome - For patients with non-ST-segment elevation ACS(unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1) - For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets has been shown to reduce the rate of MI and stroke. (1.1) Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets has been shown to reduce the rate of MI and stroke. (1.2).",
"Description": "Clopidogrel is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2- chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16CINO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows:. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration is provided as either pink colored, biconvex, round shaped, beveled edge, film coated tablets printed \"CL 75\" on one side and plain on other side containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains colloidal silicon dioxide, hydrogenated castor oil, low substituted hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and polyethylene glycol 6000 as inactive ingredients. The pink film coating contains hypromellose 2910, lactose monohydrate, red iron oxide, titanium dioxide, and triacetin. The imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac. FDA approved dissolution test and specification differ from USP."
},
{
"NDCCode": "67877-276-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (67877-276-90) ",
"NDC11Code": "67877-0276-90",
"ProductNDC": "67877-276",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clopidogrel",
"NonProprietaryName": "Clopidogrel Bisulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240516",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203632",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240516",
"SamplePackage": "N",
"IndicationAndUsage": "Clopidogrel tablets is a P2Y12 platelet inhibitor indicated for: Acute coronary syndrome - For patients with non-ST-segment elevation ACS(unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1) - For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets has been shown to reduce the rate of MI and stroke. (1.1) Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets has been shown to reduce the rate of MI and stroke. (1.2).",
"Description": "Clopidogrel is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2- chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16CINO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows:. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration is provided as either pink colored, biconvex, round shaped, beveled edge, film coated tablets printed \"CL 75\" on one side and plain on other side containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains colloidal silicon dioxide, hydrogenated castor oil, low substituted hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and polyethylene glycol 6000 as inactive ingredients. The pink film coating contains hypromellose 2910, lactose monohydrate, red iron oxide, titanium dioxide, and triacetin. The imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac. FDA approved dissolution test and specification differ from USP."
},
{
"NDCCode": "67877-707-51",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (67877-707-51) ",
"NDC11Code": "67877-0707-51",
"ProductNDC": "67877-707",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250723",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213764",
"LabelerName": "Ascend Laboratories, LLC",
"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": "2025-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250723",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, iron oxide yellow, Macrogol 4000, talc and titanium dioxide. 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 and iron oxide red."
},
{
"NDCCode": "67877-707-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (67877-707-60) ",
"NDC11Code": "67877-0707-60",
"ProductNDC": "67877-707",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250723",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213764",
"LabelerName": "Ascend Laboratories, LLC",
"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": "2025-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250723",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, iron oxide yellow, Macrogol 4000, talc and titanium dioxide. 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 and iron oxide red."
},
{
"NDCCode": "67877-708-51",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (67877-708-51) ",
"NDC11Code": "67877-0708-51",
"ProductNDC": "67877-708",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250723",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213764",
"LabelerName": "Ascend Laboratories, LLC",
"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": "2025-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250723",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, iron oxide yellow, Macrogol 4000, talc and titanium dioxide. 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 and iron oxide red."
},
{
"NDCCode": "67877-708-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (67877-708-60) ",
"NDC11Code": "67877-0708-60",
"ProductNDC": "67877-708",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250723",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213764",
"LabelerName": "Ascend Laboratories, LLC",
"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": "2025-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250723",
"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, iron oxide yellow, Macrogol 4000, talc and titanium dioxide. 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 and iron oxide red."
},
{
"NDCCode": "67877-709-51",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (67877-709-51) ",
"NDC11Code": "67877-0709-51",
"ProductNDC": "67877-709",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
"NonProprietaryName": "Sacubitril And Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
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"LabelerName": "Ascend Laboratories, LLC",
"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": "2025-07-25",
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"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, iron oxide yellow, Macrogol 4000, talc and titanium dioxide. 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 and iron oxide red."
},
{
"NDCCode": "67877-709-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (67877-709-60) ",
"NDC11Code": "67877-0709-60",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
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"LabelerName": "Ascend Laboratories, LLC",
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"Status": "Active",
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"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, iron oxide yellow, Macrogol 4000, talc and titanium dioxide. 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 and iron oxide red."
},
{
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"PackageDescription": "1 BLISTER PACK in 1 CARTON (67877-949-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sacubitril And Valsartan",
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"LabelerName": "Ascend Laboratories, LLC",
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"Status": "Active",
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"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is:Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, Macrogol 4000, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet also contains iron oxide yellow, iron oxide black and iron oxide red."
},
{
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"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is:Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, Macrogol 4000, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet also contains iron oxide yellow, iron oxide black and iron oxide red."
},
{
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"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is:Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, Macrogol 4000, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet also contains iron oxide yellow, iron oxide black and iron oxide red."
},
{
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"ProprietaryName": "Sacubitril And Valsartan",
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"Status": "Active",
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"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is:Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, Macrogol 4000, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet also contains iron oxide yellow, iron oxide black and iron oxide red."
},
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"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is:Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, Macrogol 4000, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet also contains iron oxide yellow, iron oxide black and iron oxide red."
},
{
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"SamplePackage": "N",
"IndicationAndUsage": "Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).",
"Description": "Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is:Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, Macrogol 4000, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet also contains iron oxide yellow, iron oxide black and iron oxide red."
},
{
"NDCCode": "10135-732-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (10135-732-01) ",
"NDC11Code": "10135-0732-01",
"ProductNDC": "10135-732",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mexiletine Hydrochloride",
"NonProprietaryName": "Mexiletine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213500",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "MEXILETINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220201",
"SamplePackage": "N",
"IndicationAndUsage": "Mexiletine hydrochloride capsules, USP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life- threatening. Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.",
"Description": "Mexiletine hydrochloride, USP is an orally active antiarrhythmic agent. It is a white to off-white crystalline powder with slightly bitter taste, freely soluble in water and in alcohol. Mexiletine hydrochloride, USP has a pKa of 9.2. The chemical name of mexiletine hydrochloride, USP is 1- methyl-2-(2,6-xylyloxy)ethylamine hydrochloride and its structural formula is. C 11H 17NO·HCl. Mol. Wt. 215.72. Each capsule for oral administration, contains 150 mg, 200 mg, or 250 mg of mexiletine hydrochloride, USP. 100 mg of mexiletine hydrochloride, USP is equivalent to 83.31 mg of mexiletine base. In addition, each capsule contains the following excipients: colloidal silicon dioxide, magnesium stearate and pregelatinized corn starch. The capsule shell contains: FD&C Yellow #6, gelatin and titanium dioxide. The 150 mg capsule also contains: yellow iron oxide, red iron oxide and black iron oxide. The 250 mg capsule also contains: FD&C Blue #1 and D&C Yellow #10. The imprinting ink contains: ammonium hydroxide, black iron oxide, propylene glycol and shellac."
},
{
"NDCCode": "10237-732-42",
"PackageDescription": "119 g in 1 TUBE (10237-732-42) ",
"NDC11Code": "10237-0732-42",
"ProductNDC": "10237-732",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Orajel Kids Superman",
"NonProprietaryName": "Anticavity Toothpaste",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20250107",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250107",
"SamplePackage": "N",
"IndicationAndUsage": "aids in the prevention of dental decay."
},
{
"NDCCode": "10237-732-44",
"PackageDescription": "4 TUBE in 1 BOX (10237-732-44) / 119 g in 1 TUBE",
"NDC11Code": "10237-0732-44",
"ProductNDC": "10237-732",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Orajel Kids Superman",
"NonProprietaryName": "Anticavity Toothpaste",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20250107",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "aids in the prevention of dental decay."
},
{
"NDCCode": "11084-732-27",
"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (11084-732-27)",
"NDC11Code": "11084-0732-27",
"ProductNDC": "11084-732",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Appeal Antibac",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130705",
"EndMarketingDate": "20200801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Deb USA, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".3",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-08-04",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "11559-732-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (11559-732-01) > 30 mL in 1 BOTTLE",
"NDC11Code": "11559-0732-01",
"ProductNDC": "11559-732",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Double Matte",
"ProprietaryNameSuffix": "Oil Control Makeup Spf 15",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "19980101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Estee Lauder Inc.",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": "2.2",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "11673-732-14",
"PackageDescription": "14 BLISTER PACK in 1 CARTON (11673-732-14) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "11673-0732-14",
"ProductNDC": "11673-732",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief Extended Release",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180711",
"EndMarketingDate": "20261028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207342",
"LabelerName": "TARGET Corporation",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "1200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2026-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180711",
"EndMarketingDatePackage": "20261028",
"SamplePackage": "N",
"IndicationAndUsage": "Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive."
},
{
"NDCCode": "11673-732-28",
"PackageDescription": "28 BLISTER PACK in 1 CARTON (11673-732-28) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "11673-0732-28",
"ProductNDC": "11673-732",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief Extended Release",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180711",
"EndMarketingDate": "20261028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207342",
"LabelerName": "TARGET Corporation",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "1200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]",
"Status": "Active",
"LastUpdate": "2026-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180711",
"EndMarketingDatePackage": "20261028",
"SamplePackage": "N",
"IndicationAndUsage": "Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive."
},
{
"NDCCode": "13537-732-08",
"PackageDescription": "1 TUBE in 1 BOX (13537-732-08) > 4 g in 1 TUBE (13537-732-07) ",
"NDC11Code": "13537-0732-08",
"ProductNDC": "13537-732",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Pro Hd Color High Definition Color Spf 20",
"ProprietaryNameSuffix": "(hd Coral Ensueno) - Red",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160229",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".068",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160229",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "13668-732-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (13668-732-01) ",
"NDC11Code": "13668-0732-01",
"ProductNDC": "13668-732",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211412",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240510",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib capsules are indicated.",
"Description": "Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3- (trifluoromethyl) -1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib, USP is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone K30 and sodium lauryl sulfate. The involatile ingredients in imprinting ink for all strengths (i.e. 50 mg, 100 mg, 200 mg and 400 mg) include: shellac, propylene glycol, potassium hydroxide and ferrosoferric oxide (black iron oxide). The ingredients in capsule shell of the 50 mg strength include: gelatin, titanium dioxide, Erythrosine (FD&C Red #3) and Brilliant Blue FCF (FD&C Blue #1). The ingredients in capsule shell of the 100 mg strength include: gelatin, titanium dioxide, Erythrosine (FD&C Red #3) and Brilliant Blue FCF (FD&C Blue #1). The ingredients in capsule shell of the 200 mg strength include: gelatin, titanium dioxide, Sunset Yellow FCF (FD&C Yellow #6) and Brilliant Blue FCF (FD&C Blue #1). The ingredients in capsule shell of the 400 mg strength include: gelatin, titanium dioxide and Brilliant Blue FCF (FD&C Blue #1)."
},
{
"NDCCode": "13668-732-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (13668-732-05) ",
"NDC11Code": "13668-0732-05",
"ProductNDC": "13668-732",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200306",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211412",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240510",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib capsules are indicated.",
"Description": "Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3- (trifluoromethyl) -1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib, USP is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone K30 and sodium lauryl sulfate. The involatile ingredients in imprinting ink for all strengths (i.e. 50 mg, 100 mg, 200 mg and 400 mg) include: shellac, propylene glycol, potassium hydroxide and ferrosoferric oxide (black iron oxide). The ingredients in capsule shell of the 50 mg strength include: gelatin, titanium dioxide, Erythrosine (FD&C Red #3) and Brilliant Blue FCF (FD&C Blue #1). The ingredients in capsule shell of the 100 mg strength include: gelatin, titanium dioxide, Erythrosine (FD&C Red #3) and Brilliant Blue FCF (FD&C Blue #1). The ingredients in capsule shell of the 200 mg strength include: gelatin, titanium dioxide, Sunset Yellow FCF (FD&C Yellow #6) and Brilliant Blue FCF (FD&C Blue #1). The ingredients in capsule shell of the 400 mg strength include: gelatin, titanium dioxide and Brilliant Blue FCF (FD&C Blue #1)."
},
{
"NDCCode": "16714-732-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (16714-732-01) ",
"NDC11Code": "16714-0732-01",
"ProductNDC": "16714-732",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207446",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170926",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3), 4 Ankylosing Spondylitis (AS) (1.4), 5 Acute Pain (AP) (1.5), 6 Primary Dysmenorrhea (PD) (1.6).",
"Description": "Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "16714-732-02",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (16714-732-02) ",
"NDC11Code": "16714-0732-02",
"ProductNDC": "16714-732",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207446",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170926",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3), 4 Ankylosing Spondylitis (AS) (1.4), 5 Acute Pain (AP) (1.5), 6 Primary Dysmenorrhea (PD) (1.6).",
"Description": "Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "21130-732-10",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (21130-732-10) / 5 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "21130-0732-10",
"ProductNDC": "21130-732",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Levocetirizine Dihydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210375",
"LabelerName": "Albertsons Companies",
"SubstanceName": "LEVOCETIRIZINE DIHYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180630",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>67877-732-97</NDCCode>
<PackageDescription>465 mL in 1 BOTTLE (67877-732-97) </PackageDescription>
<NDC11Code>67877-0732-97</NDC11Code>
<ProductNDC>67877-732</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide Oral Solution</ProprietaryName>
<NonProprietaryName>Lacosamide Oral Solution</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214672</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide oral solution is indicated for: 1 Treatment of partial-onset seizures in patients 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2) .</IndicationAndUsage>
<Description>The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3and its molecular weight is 250.30. The chemical structure is:Lacosamide, USP is a white to light yellow powder. It is freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile, and practically insoluble in heptane.</Description>
</NDC>
<NDC>
<NDCCode>67877-732-95</NDCCode>
<PackageDescription>200 mL in 1 BOTTLE (67877-732-95) </PackageDescription>
<NDC11Code>67877-0732-95</NDC11Code>
<ProductNDC>67877-732</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide Oral Solution</ProprietaryName>
<NonProprietaryName>Lacosamide Oral Solution</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214672</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide oral solution is indicated for: 1 Treatment of partial-onset seizures in patients 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2) .</IndicationAndUsage>
<Description>The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3and its molecular weight is 250.30. The chemical structure is:Lacosamide, USP is a white to light yellow powder. It is freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile, and practically insoluble in heptane.</Description>
</NDC>
<NDC>
<NDCCode>67877-276-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (67877-276-05) </PackageDescription>
<NDC11Code>67877-0276-05</NDC11Code>
<ProductNDC>67877-276</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203632</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clopidogrel tablets is a P2Y12 platelet inhibitor indicated for: Acute coronary syndrome - For patients with non-ST-segment elevation ACS(unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1) - For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets has been shown to reduce the rate of MI and stroke. (1.1) Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets has been shown to reduce the rate of MI and stroke. (1.2).</IndicationAndUsage>
<Description>Clopidogrel is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2- chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16CINO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows:. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration is provided as either pink colored, biconvex, round shaped, beveled edge, film coated tablets printed "CL 75" on one side and plain on other side containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains colloidal silicon dioxide, hydrogenated castor oil, low substituted hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and polyethylene glycol 6000 as inactive ingredients. The pink film coating contains hypromellose 2910, lactose monohydrate, red iron oxide, titanium dioxide, and triacetin. The imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac. FDA approved dissolution test and specification differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>67877-276-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (67877-276-30) </PackageDescription>
<NDC11Code>67877-0276-30</NDC11Code>
<ProductNDC>67877-276</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203632</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clopidogrel tablets is a P2Y12 platelet inhibitor indicated for: Acute coronary syndrome - For patients with non-ST-segment elevation ACS(unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1) - For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets has been shown to reduce the rate of MI and stroke. (1.1) Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets has been shown to reduce the rate of MI and stroke. (1.2).</IndicationAndUsage>
<Description>Clopidogrel is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2- chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16CINO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows:. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration is provided as either pink colored, biconvex, round shaped, beveled edge, film coated tablets printed "CL 75" on one side and plain on other side containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains colloidal silicon dioxide, hydrogenated castor oil, low substituted hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and polyethylene glycol 6000 as inactive ingredients. The pink film coating contains hypromellose 2910, lactose monohydrate, red iron oxide, titanium dioxide, and triacetin. The imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac. FDA approved dissolution test and specification differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>67877-276-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (67877-276-90) </PackageDescription>
<NDC11Code>67877-0276-90</NDC11Code>
<ProductNDC>67877-276</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clopidogrel</ProprietaryName>
<NonProprietaryName>Clopidogrel Bisulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240516</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203632</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240516</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clopidogrel tablets is a P2Y12 platelet inhibitor indicated for: Acute coronary syndrome - For patients with non-ST-segment elevation ACS(unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), clopidogrel tablets has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1) - For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets has been shown to reduce the rate of MI and stroke. (1.1) Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets has been shown to reduce the rate of MI and stroke. (1.2).</IndicationAndUsage>
<Description>Clopidogrel is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2- chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16CINO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows:. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration is provided as either pink colored, biconvex, round shaped, beveled edge, film coated tablets printed "CL 75" on one side and plain on other side containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains colloidal silicon dioxide, hydrogenated castor oil, low substituted hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and polyethylene glycol 6000 as inactive ingredients. The pink film coating contains hypromellose 2910, lactose monohydrate, red iron oxide, titanium dioxide, and triacetin. The imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac. FDA approved dissolution test and specification differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>67877-707-51</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (67877-707-51) </PackageDescription>
<NDC11Code>67877-0707-51</NDC11Code>
<ProductNDC>67877-707</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>20250723</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213764</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>24; 26</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>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, iron oxide yellow, Macrogol 4000, talc and titanium dioxide. 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 and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>67877-707-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (67877-707-60) </PackageDescription>
<NDC11Code>67877-0707-60</NDC11Code>
<ProductNDC>67877-707</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>20250723</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213764</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
<StrengthNumber>24; 26</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>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, iron oxide yellow, Macrogol 4000, talc and titanium dioxide. 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 and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>67877-708-51</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (67877-708-51) </PackageDescription>
<NDC11Code>67877-0708-51</NDC11Code>
<ProductNDC>67877-708</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>20250723</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213764</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</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>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, iron oxide yellow, Macrogol 4000, talc and titanium dioxide. 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 and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>67877-708-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (67877-708-60) </PackageDescription>
<NDC11Code>67877-0708-60</NDC11Code>
<ProductNDC>67877-708</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>20250723</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213764</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</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>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250723</StartMarketingDatePackage>
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<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, iron oxide yellow, Macrogol 4000, talc and titanium dioxide. 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 and iron oxide red.</Description>
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<Description>Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, iron oxide yellow, Macrogol 4000, talc and titanium dioxide. 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 and iron oxide red.</Description>
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<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is. Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, iron oxide yellow, Macrogol 4000, talc and titanium dioxide. 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 and iron oxide red.</Description>
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<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is:Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, Macrogol 4000, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet also contains iron oxide yellow, iron oxide black and iron oxide red.</Description>
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<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is:Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, Macrogol 4000, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet also contains iron oxide yellow, iron oxide black and iron oxide red.</Description>
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<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is:Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, Macrogol 4000, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet also contains iron oxide yellow, iron oxide black and iron oxide red.</Description>
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<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is:Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, Macrogol 4000, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet also contains iron oxide yellow, iron oxide black and iron oxide red.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is:Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, Macrogol 4000, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet also contains iron oxide yellow, iron oxide black and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>67877-950-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (67877-950-60) </PackageDescription>
<NDC11Code>67877-0950-60</NDC11Code>
<ProductNDC>67877-950</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>20250723</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213764</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</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>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
<Description>Sacubitril and valsartan tablets is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan and sodium cations, in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´biphenyl] -4-yl]methyl}-L valinate). Its molecular formula is C48H55N6O8Na3. Its molecular mass is 912.96 g/mol and its schematic structural formula is:Sacubitril and valsartan tablets is available as film-coated tablets for oral administration, containing 24 mg of sacubitril equivalent to 25.6 mg sacubitril monosodium and 26 mg of valsartan equivalent to 28.3 mg valsartan disodium; 49 mg of sacubitril equivalent to 51.2 mg sacubitril monosodium and 51 mg of valsartan equivalent to 56.6 mg valsartan disodium; and 97 mg of sacubitril equivalent to 102.4 mg sacubitril monosodium and 103 mg of valsartan equivalent to 113.2 mg valsartan disodium. The tablet inactive ingredients are colloidal silicon dioxide, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, sodium starch glycolate and talc. The film-coat inactive ingredients are hypromellose, Macrogol 4000, talc and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet also contains iron oxide yellow, iron oxide black and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>10135-732-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (10135-732-01) </PackageDescription>
<NDC11Code>10135-0732-01</NDC11Code>
<ProductNDC>10135-732</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mexiletine Hydrochloride</ProprietaryName>
<NonProprietaryName>Mexiletine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213500</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MEXILETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mexiletine hydrochloride capsules, USP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life- threatening. Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.</IndicationAndUsage>
<Description>Mexiletine hydrochloride, USP is an orally active antiarrhythmic agent. It is a white to off-white crystalline powder with slightly bitter taste, freely soluble in water and in alcohol. Mexiletine hydrochloride, USP has a pKa of 9.2. The chemical name of mexiletine hydrochloride, USP is 1- methyl-2-(2,6-xylyloxy)ethylamine hydrochloride and its structural formula is. C 11H 17NO·HCl. Mol. Wt. 215.72. Each capsule for oral administration, contains 150 mg, 200 mg, or 250 mg of mexiletine hydrochloride, USP. 100 mg of mexiletine hydrochloride, USP is equivalent to 83.31 mg of mexiletine base. In addition, each capsule contains the following excipients: colloidal silicon dioxide, magnesium stearate and pregelatinized corn starch. The capsule shell contains: FD&C Yellow #6, gelatin and titanium dioxide. The 150 mg capsule also contains: yellow iron oxide, red iron oxide and black iron oxide. The 250 mg capsule also contains: FD&C Blue #1 and D&C Yellow #10. The imprinting ink contains: ammonium hydroxide, black iron oxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>10237-732-42</NDCCode>
<PackageDescription>119 g in 1 TUBE (10237-732-42) </PackageDescription>
<NDC11Code>10237-0732-42</NDC11Code>
<ProductNDC>10237-732</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Orajel Kids Superman</ProprietaryName>
<NonProprietaryName>Anticavity Toothpaste</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20250107</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>aids in the prevention of dental decay.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10237-732-44</NDCCode>
<PackageDescription>4 TUBE in 1 BOX (10237-732-44) / 119 g in 1 TUBE</PackageDescription>
<NDC11Code>10237-0732-44</NDC11Code>
<ProductNDC>10237-732</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Orajel Kids Superman</ProprietaryName>
<NonProprietaryName>Anticavity Toothpaste</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20250107</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>aids in the prevention of dental decay.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11084-732-27</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (11084-732-27)</PackageDescription>
<NDC11Code>11084-0732-27</NDC11Code>
<ProductNDC>11084-732</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Appeal Antibac</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130705</StartMarketingDate>
<EndMarketingDate>20200801</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Deb USA, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>11559-732-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11559-732-01) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11559-0732-01</NDC11Code>
<ProductNDC>11559-732</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Double Matte</ProprietaryName>
<ProprietaryNameSuffix>Oil Control Makeup Spf 15</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19980101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Estee Lauder Inc.</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>2.2</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11673-732-14</NDCCode>
<PackageDescription>14 BLISTER PACK in 1 CARTON (11673-732-14) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11673-0732-14</NDC11Code>
<ProductNDC>11673-732</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus Relief Extended Release</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180711</StartMarketingDate>
<EndMarketingDate>20261028</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207342</ApplicationNumber>
<LabelerName>TARGET Corporation</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180711</StartMarketingDatePackage>
<EndMarketingDatePackage>20261028</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11673-732-28</NDCCode>
<PackageDescription>28 BLISTER PACK in 1 CARTON (11673-732-28) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11673-0732-28</NDC11Code>
<ProductNDC>11673-732</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus Relief Extended Release</ProprietaryName>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180711</StartMarketingDate>
<EndMarketingDate>20261028</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207342</ApplicationNumber>
<LabelerName>TARGET Corporation</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180711</StartMarketingDatePackage>
<EndMarketingDatePackage>20261028</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13537-732-08</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-732-08) > 4 g in 1 TUBE (13537-732-07) </PackageDescription>
<NDC11Code>13537-0732-08</NDC11Code>
<ProductNDC>13537-732</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Pro Hd Color High Definition Color Spf 20</ProprietaryName>
<ProprietaryNameSuffix>(hd Coral Ensueno) - Red</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160229</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>.068</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13668-732-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (13668-732-01) </PackageDescription>
<NDC11Code>13668-0732-01</NDC11Code>
<ProductNDC>13668-732</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211412</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib capsules are indicated.</IndicationAndUsage>
<Description>Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3- (trifluoromethyl) -1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib, USP is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone K30 and sodium lauryl sulfate. The involatile ingredients in imprinting ink for all strengths (i.e. 50 mg, 100 mg, 200 mg and 400 mg) include: shellac, propylene glycol, potassium hydroxide and ferrosoferric oxide (black iron oxide). The ingredients in capsule shell of the 50 mg strength include: gelatin, titanium dioxide, Erythrosine (FD&C Red #3) and Brilliant Blue FCF (FD&C Blue #1). The ingredients in capsule shell of the 100 mg strength include: gelatin, titanium dioxide, Erythrosine (FD&C Red #3) and Brilliant Blue FCF (FD&C Blue #1). The ingredients in capsule shell of the 200 mg strength include: gelatin, titanium dioxide, Sunset Yellow FCF (FD&C Yellow #6) and Brilliant Blue FCF (FD&C Blue #1). The ingredients in capsule shell of the 400 mg strength include: gelatin, titanium dioxide and Brilliant Blue FCF (FD&C Blue #1).</Description>
</NDC>
<NDC>
<NDCCode>13668-732-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (13668-732-05) </PackageDescription>
<NDC11Code>13668-0732-05</NDC11Code>
<ProductNDC>13668-732</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200306</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211412</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib capsules are indicated.</IndicationAndUsage>
<Description>Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3- (trifluoromethyl) -1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib, USP is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone K30 and sodium lauryl sulfate. The involatile ingredients in imprinting ink for all strengths (i.e. 50 mg, 100 mg, 200 mg and 400 mg) include: shellac, propylene glycol, potassium hydroxide and ferrosoferric oxide (black iron oxide). The ingredients in capsule shell of the 50 mg strength include: gelatin, titanium dioxide, Erythrosine (FD&C Red #3) and Brilliant Blue FCF (FD&C Blue #1). The ingredients in capsule shell of the 100 mg strength include: gelatin, titanium dioxide, Erythrosine (FD&C Red #3) and Brilliant Blue FCF (FD&C Blue #1). The ingredients in capsule shell of the 200 mg strength include: gelatin, titanium dioxide, Sunset Yellow FCF (FD&C Yellow #6) and Brilliant Blue FCF (FD&C Blue #1). The ingredients in capsule shell of the 400 mg strength include: gelatin, titanium dioxide and Brilliant Blue FCF (FD&C Blue #1).</Description>
</NDC>
<NDC>
<NDCCode>16714-732-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (16714-732-01) </PackageDescription>
<NDC11Code>16714-0732-01</NDC11Code>
<ProductNDC>16714-732</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207446</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<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>2025-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3), 4 Ankylosing Spondylitis (AS) (1.4), 5 Acute Pain (AP) (1.5), 6 Primary Dysmenorrhea (PD) (1.6).</IndicationAndUsage>
<Description>Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>16714-732-02</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (16714-732-02) </PackageDescription>
<NDC11Code>16714-0732-02</NDC11Code>
<ProductNDC>16714-732</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207446</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<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>2025-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3), 4 Ankylosing Spondylitis (AS) (1.4), 5 Acute Pain (AP) (1.5), 6 Primary Dysmenorrhea (PD) (1.6).</IndicationAndUsage>
<Description>Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>21130-732-10</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (21130-732-10) / 5 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21130-0732-10</NDC11Code>
<ProductNDC>21130-732</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Levocetirizine Dihydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210375</ApplicationNumber>
<LabelerName>Albertsons Companies</LabelerName>
<SubstanceName>LEVOCETIRIZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
</NDCList>