{
"NDC": [
{
"NDCCode": "69238-2578-3",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2578-3) ",
"NDC11Code": "69238-2578-03",
"ProductNDC": "69238-2578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "69238-2578-1",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2578-1) ",
"NDC11Code": "69238-2578-01",
"ProductNDC": "69238-2578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "69238-2578-2",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2578-2) ",
"NDC11Code": "69238-2578-02",
"ProductNDC": "69238-2578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "69238-2578-9",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2578-9) ",
"NDC11Code": "69238-2578-09",
"ProductNDC": "69238-2578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol Phosphate",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204717",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure. (1.1), 2 left ventricular dysfunction following myocardial infarction in clinically stable patients. (1.2), 3 hypertension. (1.3).",
"Description": "Carvedilol phosphate is a nonselective beta-adrenergic blocking agent with alpha1-blocking activity. It is (2RS)-1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemiethanolate. It is a racemic mixture with the following structure. Carvedilol phosphate is a white to almost-white solid with a molecular weight of 527.47 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4H3PO41/2 EtOH. Carvedilol phosphate is available for once-a-day administration as extended-release oral capsules containing 10 mg, 20 mg, 40 mg, or 80 mg carvedilol phosphate. Carvedilol phosphate extended-release hard gelatin capsules are filled with carvedilol phosphate extended-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include corn starch, crospovidone, hydrogenated cottonseed oil, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyvinyl alcohol, povidone, silicon dioxide, soybean lecithin, sucrose, talc, titanium dioxide, triethyl citrate and xanthan gum. The 10 mg capsule shells contain D&C Yellow No. 10, FD&C Green No. 3, gelatin and titanium dioxide. The 20 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, gelatin and titanium dioxide. The 40 mg capsule shells contain D&C Red No. 28, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, gelatin and titanium dioxide. The 80 mg capsule shells contain gelatin and titanium dioxide. Additionally, the capsule imprint ink contains FD&C Blue No. 1, FD&C Blue No. 2, D&C Yellow No. 10, FD&C Red No. 40, iron oxide black and shellac."
},
{
"NDCCode": "0002-2578-00",
"PackageDescription": "3 mL in 1 SYRINGE (0002-2578-00) ",
"NDC11Code": "00002-2578-00",
"ProductNDC": "0002-2578",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Insulin Lispro-aabc",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20200615",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "200",
"StrengthUnit": "[iU]/mL",
"Status": "Unfinished",
"LastUpdate": "2022-03-16",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "15-JUN-20"
},
{
"NDCCode": "36987-2578-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-2578-3)",
"NDC11Code": "36987-2578-03",
"ProductNDC": "36987-2578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Red Cedar",
"NonProprietaryName": "Red Cedar",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "JUNIPERUS VIRGINIANA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-2578-3",
"PackageDescription": "4000 PELLET in 1 BOTTLE, GLASS (37662-2578-3) ",
"NDC11Code": "37662-2578-03",
"ProductNDC": "37662-2578",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Etherum",
"NonProprietaryName": "Etherum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "ETHER",
"StrengthNumber": "12",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230131",
"SamplePackage": "N"
},
{
"NDCCode": "60232-2578-3",
"PackageDescription": "85 g in 1 TUBE (60232-2578-3)",
"NDC11Code": "60232-2578-03",
"ProductNDC": "60232-2578",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eltamd Uv Physicalspf 41",
"ProprietaryNameSuffix": "Spf 41",
"NonProprietaryName": "Eltamd Uv Physical Spf 41",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20020430",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Swiss-American Products",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
"StrengthNumber": "90; 70",
"StrengthUnit": "g/1000g; g/1000g",
"Status": "Deprecated",
"LastUpdate": "2018-09-02",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "60505-2578-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (60505-2578-3) ",
"NDC11Code": "60505-2578-03",
"ProductNDC": "60505-2578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090548",
"LabelerName": "Apotex Corp.",
"SubstanceName": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120529",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin Calcium Tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemiaHypertriglyceridemia.",
"Description": "Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C66H68CaF2N4O10 * C3H8O2 and its molecular weight is 1231.46 g/mol. Its structural formula is. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain atorvastatin 10, 20, 40, or 80 mg (equivalent to 11, 22, 44 or 88 mg atorvastatin calcium) and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide."
},
{
"NDCCode": "70786-2578-3",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70786-2578-3) ",
"NDC11Code": "70786-2578-03",
"ProductNDC": "70786-2578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090548",
"LabelerName": "Unit Dose Services",
"SubstanceName": "ATORVASTATIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "71335-2578-3",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-3) ",
"NDC11Code": "71335-2578-03",
"ProductNDC": "71335-2578",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alfuzosin Hydrochloride",
"NonProprietaryName": "Alfuzosin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079060",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "ALFUZOSIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250206",
"SamplePackage": "N",
"IndicationAndUsage": "Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.",
"Description": "Each alfuzosin hydrochloride extended-release tablet USP contains 10 mg alfuzosin hydrochloride USP as the active ingredient. Alfuzosin hydrochloride USP is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The molecular formula of alfuzosin hydrochloride is C19H27N5O4HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is: The tablet also contains the following inactive ingredients: carbomer, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, magnesium stearate, povidone, propylene glycol, and titanium dioxide. Meets USP Dissolution Test 5."
},
{
"NDCCode": "72043-2578-3",
"PackageDescription": "85 g in 1 TUBE (72043-2578-3) ",
"NDC11Code": "72043-2578-03",
"ProductNDC": "72043-2578",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eltamd Uv Physical Spf41",
"NonProprietaryName": "Zinc Oxide And Titanium Dioxide Sunscrreen",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180110",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "CP Skin Health Group, Inc.",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
"StrengthNumber": "70; 90",
"StrengthUnit": "g/1000g; g/1000g",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180110",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn if used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "15631-2578-0",
"PackageDescription": "10 mL in 1 BOTTLE (15631-2578-0) ",
"NDC11Code": "15631-2578-00",
"ProductNDC": "15631-2578",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ammon Carbon",
"NonProprietaryName": "Ammon Carbon",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20240523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "AMMONIUM CARBONATE",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/mL",
"Status": "Active",
"LastUpdate": "2024-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240523",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-2578-1",
"PackageDescription": "30 mL in 1 BOTTLE (15631-2578-1) ",
"NDC11Code": "15631-2578-01",
"ProductNDC": "15631-2578",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ammon Carbon",
"NonProprietaryName": "Ammon Carbon",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20240523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "AMMONIUM CARBONATE",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/mL",
"Status": "Active",
"LastUpdate": "2024-06-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240523",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "69238-1017-3",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (69238-1017-3) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69238-1017-1) ",
"NDC11Code": "69238-1017-03",
"ProductNDC": "69238-1017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isotretinoin",
"NonProprietaryName": "Isotretinoin",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20171002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207792",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ISOTRETINOIN",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171002",
"SamplePackage": "N",
"IndicationAndUsage": "Isotretinoin Capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, Isotretinoin Capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of Isotretinoin Capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of treatment [see Dosage and Administration (2.2)].",
"Description": "Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. Isotretinoin has high lipophilicity. The structural formula is. Isotretinoin capsules, USP contain 10 mg, 20 mg, 30 mg or 40 mg of isotretinoin (a retinoid) in soft gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, USP, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, gelatin, glycerin, hydrogenated vegetable oil, purified water, soybean oil, titanium dioxide, and white wax (beeswax). In addition, the 10 mg capsule contains iron oxide black and iron oxide yellow. The 20 mg capsule contains iron oxide black, iron oxide red and iron oxide yellow. The 30 mg capsule contains FD&C yellow #6 aluminum lake. The 40 mg capsule contains FD&C yellow #6 aluminum lake. Product meets USP Dissolution Test 4."
},
{
"NDCCode": "69238-1023-3",
"PackageDescription": "3 POUCH in 1 CARTON (69238-1023-3) / 10 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "69238-1023-03",
"ProductNDC": "69238-1023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclosporine",
"NonProprietaryName": "Cyclosporine",
"DosageFormName": "EMULSION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211909",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "CYCLOSPORINE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.",
"Description": "Cyclosporine ophthalmic emulsion 0.05% contains a topical calcineurin inhibitor immunosuppressant with anti-inflammatory effects. Cyclosporine’s, USP chemical name is Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure:. Structural Formula. Formula: C62H111N11O12 Mol. Wt.: 1202.6. Cyclosporine, USP is a white to almost white powder. Cyclosporine ophthalmic emulsion appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5 to 8.0. Each mL of cyclosporine ophthalmic emulsion contains: Active: cyclosporine, USP 0.05%. Inactives: glycerin; castor oil; polysorbate 80; carbomer copolymer type A; water for injection; and sodium hydroxide to adjust pH."
},
{
"NDCCode": "69238-1031-7",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (69238-1031-7) / 1 KIT in 1 BLISTER PACK (69238-1031-6) ",
"NDC11Code": "69238-1031-07",
"ProductNDC": "69238-1031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Melodetta 24 Fe",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20170921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207514",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"Status": "Active",
"LastUpdate": "2023-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170921",
"SamplePackage": "N",
"IndicationAndUsage": "Melodetta 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. The efficacy of Melodetta 24 Fe in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.",
"Description": "Melodetta 24 Fe provides an oral contraceptive regimen consisting of 24 white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below: : 1 24 white, round tablets each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. , 2 4 brown, round tablets each containing 75 mg ferrous fumarate. ."
},
{
"NDCCode": "69238-1050-3",
"PackageDescription": "3 BOTTLE in 1 CARTON (69238-1050-3) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) ",
"NDC11Code": "69238-1050-03",
"ProductNDC": "69238-1050",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209716",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190605",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "69238-1050-8",
"PackageDescription": "3 BOTTLE in 1 BLISTER PACK (69238-1050-8) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) ",
"NDC11Code": "69238-1050-08",
"ProductNDC": "69238-1050",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190605",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209716",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190605",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "69238-1051-3",
"PackageDescription": "1 BOTTLE in 1 CARTON (69238-1051-3) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "69238-1051-03",
"ProductNDC": "69238-1051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phytonadione",
"NonProprietaryName": "Phytonadione",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209373",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "PHYTONADIONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180515",
"SamplePackage": "N",
"IndicationAndUsage": "Phytonadione tablets are indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 Anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives. , 2 Hypoprothrombinemia secondary to antibacterial therapy. , 3 Hypoprothrombinemia secondary to factors limiting absorpsion or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis., 4 Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.",
"Description": "Phytonadione is a vitamin K replacement, which is a clear, yellow to amber, very viscous, odorless or practically odourless liquid. It is soluble in dehydrated alcohol, benzene, chloroform and ether; slightly soluble in alcohol (96%) and insoluble in water. It has a molecular weight of 450.70 g/mol. Phytonadione is 1,4-Naphthalenedione, 2-methyl-3-(3,7,11,15-tetramethyl-2-hexadecenyl)-,[R-[R*,R*-(E)]]. Its molecular formula is C31H46O2 and its structural formula is. Phytonadione tablets, USP for oral administration contain 5 mg of phytonadione, USP and are light yellow to yellow colored, round, scored tablets, debossed with “AA” and “05” on either side of scoring and plain on the other side. Inactive ingredients are acacia, anhydrous dibasic calcium phosphate, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, and talc."
},
{
"NDCCode": "69238-1053-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69238-1053-3) ",
"NDC11Code": "69238-1053-03",
"ProductNDC": "69238-1053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desipramine Hydrochloride",
"NonProprietaryName": "Desipramine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160321",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208105",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160321",
"SamplePackage": "N",
"IndicationAndUsage": "Desipramine hydrochloride tablets are indicated for the treatment of depression.",
"Description": "Desipramine hydrochloride tablets, USP are an antidepressant drug of the tricyclic type, and is chemically: 5H-Dibenz[bƒ]azepine-5-propanamine,10,11-dihydro-N-methyl-, monohydrochloride. Each desipramine hydrochloride tablet, USP contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride, USP for oral administration. Inactive IngredientsDesipramine hydrochloride tablets, USP contain the following inactive ingredients: corn starch, D&C Red #27 aluminum lake (in 75 mg), FD&C Blue #1 aluminum lake (in 10 mg and 50 mg), FD&C Blue #2 aluminum lake (in 10 mg), FD&C Red #40 aluminum lake (in 75 mg), FD&C Yellow #6 aluminum lake (in 50 mg, 75 mg and 100 mg), hydroxypropyl cellulose, hypromellose, iron oxide red (in 100 mg), iron oxide yellow (in 25 mg and 50 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "69238-1055-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69238-1055-3) ",
"NDC11Code": "69238-1055-03",
"ProductNDC": "69238-1055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desipramine Hydrochloride",
"NonProprietaryName": "Desipramine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160321",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208105",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160321",
"SamplePackage": "N",
"IndicationAndUsage": "Desipramine hydrochloride tablets are indicated for the treatment of depression.",
"Description": "Desipramine hydrochloride tablets, USP are an antidepressant drug of the tricyclic type, and is chemically: 5H-Dibenz[bƒ]azepine-5-propanamine,10,11-dihydro-N-methyl-, monohydrochloride. Each desipramine hydrochloride tablet, USP contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride, USP for oral administration. Inactive IngredientsDesipramine hydrochloride tablets, USP contain the following inactive ingredients: corn starch, D&C Red #27 aluminum lake (in 75 mg), FD&C Blue #1 aluminum lake (in 10 mg and 50 mg), FD&C Blue #2 aluminum lake (in 10 mg), FD&C Red #40 aluminum lake (in 75 mg), FD&C Yellow #6 aluminum lake (in 50 mg, 75 mg and 100 mg), hydroxypropyl cellulose, hypromellose, iron oxide red (in 100 mg), iron oxide yellow (in 25 mg and 50 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "69238-1057-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69238-1057-3) ",
"NDC11Code": "69238-1057-03",
"ProductNDC": "69238-1057",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desipramine Hydrochloride",
"NonProprietaryName": "Desipramine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160321",
"EndMarketingDate": "20280131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208105",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160321",
"EndMarketingDatePackage": "20280131",
"SamplePackage": "N",
"IndicationAndUsage": "Desipramine hydrochloride tablets are indicated for the treatment of depression.",
"Description": "Desipramine hydrochloride tablets, USP are an antidepressant drug of the tricyclic type, and is chemically: 5H-Dibenz[bƒ]azepine-5-propanamine,10,11-dihydro-N-methyl-, monohydrochloride. Each desipramine hydrochloride tablet, USP contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride, USP for oral administration. Inactive IngredientsDesipramine hydrochloride tablets, USP contain the following inactive ingredients: corn starch, D&C Red #27 aluminum lake (in 75 mg), FD&C Blue #1 aluminum lake (in 10 mg and 50 mg), FD&C Blue #2 aluminum lake (in 10 mg), FD&C Red #40 aluminum lake (in 75 mg), FD&C Yellow #6 aluminum lake (in 50 mg, 75 mg and 100 mg), hydroxypropyl cellulose, hypromellose, iron oxide red (in 100 mg), iron oxide yellow (in 25 mg and 50 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "69238-1059-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69238-1059-3) ",
"NDC11Code": "69238-1059-03",
"ProductNDC": "69238-1059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desipramine Hydrochloride",
"NonProprietaryName": "Desipramine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160321",
"EndMarketingDate": "20270630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208105",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160321",
"EndMarketingDatePackage": "20270630",
"SamplePackage": "N",
"IndicationAndUsage": "Desipramine hydrochloride tablets are indicated for the treatment of depression.",
"Description": "Desipramine hydrochloride tablets, USP are an antidepressant drug of the tricyclic type, and is chemically: 5H-Dibenz[bƒ]azepine-5-propanamine,10,11-dihydro-N-methyl-, monohydrochloride. Each desipramine hydrochloride tablet, USP contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride, USP for oral administration. Inactive IngredientsDesipramine hydrochloride tablets, USP contain the following inactive ingredients: corn starch, D&C Red #27 aluminum lake (in 75 mg), FD&C Blue #1 aluminum lake (in 10 mg and 50 mg), FD&C Blue #2 aluminum lake (in 10 mg), FD&C Red #40 aluminum lake (in 75 mg), FD&C Yellow #6 aluminum lake (in 50 mg, 75 mg and 100 mg), hydroxypropyl cellulose, hypromellose, iron oxide red (in 100 mg), iron oxide yellow (in 25 mg and 50 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "69238-1061-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69238-1061-3) ",
"NDC11Code": "69238-1061-03",
"ProductNDC": "69238-1061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desipramine Hydrochloride",
"NonProprietaryName": "Desipramine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160321",
"EndMarketingDate": "20271231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208105",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160321",
"EndMarketingDatePackage": "20271231",
"SamplePackage": "N",
"IndicationAndUsage": "Desipramine hydrochloride tablets are indicated for the treatment of depression.",
"Description": "Desipramine hydrochloride tablets, USP are an antidepressant drug of the tricyclic type, and is chemically: 5H-Dibenz[bƒ]azepine-5-propanamine,10,11-dihydro-N-methyl-, monohydrochloride. Each desipramine hydrochloride tablet, USP contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride, USP for oral administration. Inactive IngredientsDesipramine hydrochloride tablets, USP contain the following inactive ingredients: corn starch, D&C Red #27 aluminum lake (in 75 mg), FD&C Blue #1 aluminum lake (in 10 mg and 50 mg), FD&C Blue #2 aluminum lake (in 10 mg), FD&C Red #40 aluminum lake (in 75 mg), FD&C Yellow #6 aluminum lake (in 50 mg, 75 mg and 100 mg), hydroxypropyl cellulose, hypromellose, iron oxide red (in 100 mg), iron oxide yellow (in 25 mg and 50 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "69238-1100-3",
"PackageDescription": "20 CAPSULE in 1 BOTTLE (69238-1100-3) ",
"NDC11Code": "69238-1100-03",
"ProductNDC": "69238-1100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207289",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160628",
"SamplePackage": "N"
},
{
"NDCCode": "69238-1104-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (69238-1104-3) ",
"NDC11Code": "69238-1104-03",
"ProductNDC": "69238-1104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiagabine Hydrochloride",
"NonProprietaryName": "Tiagabine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208181",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "TIAGABINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
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}
]
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<DosageFormName>INJECTION, SOLUTION</DosageFormName>
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<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
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<StrengthUnit>[iU]/mL</StrengthUnit>
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<LastUpdate>2022-03-16</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-JUN-20</StartMarketingDatePackage>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<NonProprietaryName>Red Cedar</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
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<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
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<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
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<SamplePackage>N</SamplePackage>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eltamd Uv Physicalspf 41</ProprietaryName>
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<NonProprietaryName>Eltamd Uv Physical Spf 41</NonProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
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<LabelerName>Swiss-American Products</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
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<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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<ProductNDC>60505-2578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090548</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin Calcium Tablets are indicated: : 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemiaHypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C66H68CaF2N4O10 * C3H8O2 and its molecular weight is 1231.46 g/mol. Its structural formula is. Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral administration contain atorvastatin 10, 20, 40, or 80 mg (equivalent to 11, 22, 44 or 88 mg atorvastatin calcium) and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70786-2578-3</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (70786-2578-3) </PackageDescription>
<NDC11Code>70786-2578-03</NDC11Code>
<ProductNDC>70786-2578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090548</ApplicationNumber>
<LabelerName>Unit Dose Services</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71335-2578-3</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2578-3) </PackageDescription>
<NDC11Code>71335-2578-03</NDC11Code>
<ProductNDC>71335-2578</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alfuzosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Alfuzosin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079060</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ALFUZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.</IndicationAndUsage>
<Description>Each alfuzosin hydrochloride extended-release tablet USP contains 10 mg alfuzosin hydrochloride USP as the active ingredient. Alfuzosin hydrochloride USP is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The molecular formula of alfuzosin hydrochloride is C19H27N5O4HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is: The tablet also contains the following inactive ingredients: carbomer, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, magnesium stearate, povidone, propylene glycol, and titanium dioxide. Meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>72043-2578-3</NDCCode>
<PackageDescription>85 g in 1 TUBE (72043-2578-3) </PackageDescription>
<NDC11Code>72043-2578-03</NDC11Code>
<ProductNDC>72043-2578</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eltamd Uv Physical Spf41</ProprietaryName>
<NonProprietaryName>Zinc Oxide And Titanium Dioxide Sunscrreen</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180110</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>CP Skin Health Group, Inc.</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>70; 90</StrengthNumber>
<StrengthUnit>g/1000g; g/1000g</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180110</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn if used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-2578-0</NDCCode>
<PackageDescription>10 mL in 1 BOTTLE (15631-2578-0) </PackageDescription>
<NDC11Code>15631-2578-00</NDC11Code>
<ProductNDC>15631-2578</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ammon Carbon</ProprietaryName>
<NonProprietaryName>Ammon Carbon</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>AMMONIUM CARBONATE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-2578-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (15631-2578-1) </PackageDescription>
<NDC11Code>15631-2578-01</NDC11Code>
<ProductNDC>15631-2578</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ammon Carbon</ProprietaryName>
<NonProprietaryName>Ammon Carbon</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>AMMONIUM CARBONATE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-06-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69238-1017-3</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (69238-1017-3) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69238-1017-1) </PackageDescription>
<NDC11Code>69238-1017-03</NDC11Code>
<ProductNDC>69238-1017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isotretinoin</ProprietaryName>
<NonProprietaryName>Isotretinoin</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207792</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>ISOTRETINOIN</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotretinoin Capsules is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, Isotretinoin Capsules is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use. If a second course of Isotretinoin Capsules treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of treatment [see Dosage and Administration (2.2)].</IndicationAndUsage>
<Description>Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. Isotretinoin has high lipophilicity. The structural formula is. Isotretinoin capsules, USP contain 10 mg, 20 mg, 30 mg or 40 mg of isotretinoin (a retinoid) in soft gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, USP, each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, gelatin, glycerin, hydrogenated vegetable oil, purified water, soybean oil, titanium dioxide, and white wax (beeswax). In addition, the 10 mg capsule contains iron oxide black and iron oxide yellow. The 20 mg capsule contains iron oxide black, iron oxide red and iron oxide yellow. The 30 mg capsule contains FD&C yellow #6 aluminum lake. The 40 mg capsule contains FD&C yellow #6 aluminum lake. Product meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>69238-1023-3</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (69238-1023-3) / 10 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>69238-1023-03</NDC11Code>
<ProductNDC>69238-1023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclosporine</ProprietaryName>
<NonProprietaryName>Cyclosporine</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20251201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211909</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>CYCLOSPORINE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.</IndicationAndUsage>
<Description>Cyclosporine ophthalmic emulsion 0.05% contains a topical calcineurin inhibitor immunosuppressant with anti-inflammatory effects. Cyclosporine’s, USP chemical name is Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure:. Structural Formula. Formula: C62H111N11O12 Mol. Wt.: 1202.6. Cyclosporine, USP is a white to almost white powder. Cyclosporine ophthalmic emulsion appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5 to 8.0. Each mL of cyclosporine ophthalmic emulsion contains: Active: cyclosporine, USP 0.05%. Inactives: glycerin; castor oil; polysorbate 80; carbomer copolymer type A; water for injection; and sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>69238-1031-7</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (69238-1031-7) / 1 KIT in 1 BLISTER PACK (69238-1031-6) </PackageDescription>
<NDC11Code>69238-1031-07</NDC11Code>
<ProductNDC>69238-1031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Melodetta 24 Fe</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20170921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207514</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Melodetta 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. The efficacy of Melodetta 24 Fe in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.</IndicationAndUsage>
<Description>Melodetta 24 Fe provides an oral contraceptive regimen consisting of 24 white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below: : 1 24 white, round tablets each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. , 2 4 brown, round tablets each containing 75 mg ferrous fumarate. .</Description>
</NDC>
<NDC>
<NDCCode>69238-1050-3</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (69238-1050-3) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) </PackageDescription>
<NDC11Code>69238-1050-03</NDC11Code>
<ProductNDC>69238-1050</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209716</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69238-1050-8</NDCCode>
<PackageDescription>3 BOTTLE in 1 BLISTER PACK (69238-1050-8) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) </PackageDescription>
<NDC11Code>69238-1050-08</NDC11Code>
<ProductNDC>69238-1050</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190605</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209716</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69238-1051-3</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69238-1051-3) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>69238-1051-03</NDC11Code>
<ProductNDC>69238-1051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phytonadione</ProprietaryName>
<NonProprietaryName>Phytonadione</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209373</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>PHYTONADIONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phytonadione tablets are indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 Anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives. , 2 Hypoprothrombinemia secondary to antibacterial therapy. , 3 Hypoprothrombinemia secondary to factors limiting absorpsion or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis., 4 Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.</IndicationAndUsage>
<Description>Phytonadione is a vitamin K replacement, which is a clear, yellow to amber, very viscous, odorless or practically odourless liquid. It is soluble in dehydrated alcohol, benzene, chloroform and ether; slightly soluble in alcohol (96%) and insoluble in water. It has a molecular weight of 450.70 g/mol. Phytonadione is 1,4-Naphthalenedione, 2-methyl-3-(3,7,11,15-tetramethyl-2-hexadecenyl)-,[R-[R*,R*-(E)]]. Its molecular formula is C31H46O2 and its structural formula is. Phytonadione tablets, USP for oral administration contain 5 mg of phytonadione, USP and are light yellow to yellow colored, round, scored tablets, debossed with “AA” and “05” on either side of scoring and plain on the other side. Inactive ingredients are acacia, anhydrous dibasic calcium phosphate, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, and talc.</Description>
</NDC>
<NDC>
<NDCCode>69238-1053-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69238-1053-3) </PackageDescription>
<NDC11Code>69238-1053-03</NDC11Code>
<ProductNDC>69238-1053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Desipramine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160321</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208105</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desipramine hydrochloride tablets are indicated for the treatment of depression.</IndicationAndUsage>
<Description>Desipramine hydrochloride tablets, USP are an antidepressant drug of the tricyclic type, and is chemically: 5H-Dibenz[bƒ]azepine-5-propanamine,10,11-dihydro-N-methyl-, monohydrochloride. Each desipramine hydrochloride tablet, USP contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride, USP for oral administration. Inactive IngredientsDesipramine hydrochloride tablets, USP contain the following inactive ingredients: corn starch, D&C Red #27 aluminum lake (in 75 mg), FD&C Blue #1 aluminum lake (in 10 mg and 50 mg), FD&C Blue #2 aluminum lake (in 10 mg), FD&C Red #40 aluminum lake (in 75 mg), FD&C Yellow #6 aluminum lake (in 50 mg, 75 mg and 100 mg), hydroxypropyl cellulose, hypromellose, iron oxide red (in 100 mg), iron oxide yellow (in 25 mg and 50 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>69238-1055-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69238-1055-3) </PackageDescription>
<NDC11Code>69238-1055-03</NDC11Code>
<ProductNDC>69238-1055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Desipramine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160321</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208105</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desipramine hydrochloride tablets are indicated for the treatment of depression.</IndicationAndUsage>
<Description>Desipramine hydrochloride tablets, USP are an antidepressant drug of the tricyclic type, and is chemically: 5H-Dibenz[bƒ]azepine-5-propanamine,10,11-dihydro-N-methyl-, monohydrochloride. Each desipramine hydrochloride tablet, USP contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride, USP for oral administration. Inactive IngredientsDesipramine hydrochloride tablets, USP contain the following inactive ingredients: corn starch, D&C Red #27 aluminum lake (in 75 mg), FD&C Blue #1 aluminum lake (in 10 mg and 50 mg), FD&C Blue #2 aluminum lake (in 10 mg), FD&C Red #40 aluminum lake (in 75 mg), FD&C Yellow #6 aluminum lake (in 50 mg, 75 mg and 100 mg), hydroxypropyl cellulose, hypromellose, iron oxide red (in 100 mg), iron oxide yellow (in 25 mg and 50 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>69238-1057-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69238-1057-3) </PackageDescription>
<NDC11Code>69238-1057-03</NDC11Code>
<ProductNDC>69238-1057</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Desipramine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160321</StartMarketingDate>
<EndMarketingDate>20280131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208105</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160321</StartMarketingDatePackage>
<EndMarketingDatePackage>20280131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desipramine hydrochloride tablets are indicated for the treatment of depression.</IndicationAndUsage>
<Description>Desipramine hydrochloride tablets, USP are an antidepressant drug of the tricyclic type, and is chemically: 5H-Dibenz[bƒ]azepine-5-propanamine,10,11-dihydro-N-methyl-, monohydrochloride. Each desipramine hydrochloride tablet, USP contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride, USP for oral administration. Inactive IngredientsDesipramine hydrochloride tablets, USP contain the following inactive ingredients: corn starch, D&C Red #27 aluminum lake (in 75 mg), FD&C Blue #1 aluminum lake (in 10 mg and 50 mg), FD&C Blue #2 aluminum lake (in 10 mg), FD&C Red #40 aluminum lake (in 75 mg), FD&C Yellow #6 aluminum lake (in 50 mg, 75 mg and 100 mg), hydroxypropyl cellulose, hypromellose, iron oxide red (in 100 mg), iron oxide yellow (in 25 mg and 50 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>69238-1059-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69238-1059-3) </PackageDescription>
<NDC11Code>69238-1059-03</NDC11Code>
<ProductNDC>69238-1059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Desipramine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160321</StartMarketingDate>
<EndMarketingDate>20270630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208105</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160321</StartMarketingDatePackage>
<EndMarketingDatePackage>20270630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desipramine hydrochloride tablets are indicated for the treatment of depression.</IndicationAndUsage>
<Description>Desipramine hydrochloride tablets, USP are an antidepressant drug of the tricyclic type, and is chemically: 5H-Dibenz[bƒ]azepine-5-propanamine,10,11-dihydro-N-methyl-, monohydrochloride. Each desipramine hydrochloride tablet, USP contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride, USP for oral administration. Inactive IngredientsDesipramine hydrochloride tablets, USP contain the following inactive ingredients: corn starch, D&C Red #27 aluminum lake (in 75 mg), FD&C Blue #1 aluminum lake (in 10 mg and 50 mg), FD&C Blue #2 aluminum lake (in 10 mg), FD&C Red #40 aluminum lake (in 75 mg), FD&C Yellow #6 aluminum lake (in 50 mg, 75 mg and 100 mg), hydroxypropyl cellulose, hypromellose, iron oxide red (in 100 mg), iron oxide yellow (in 25 mg and 50 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>69238-1061-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69238-1061-3) </PackageDescription>
<NDC11Code>69238-1061-03</NDC11Code>
<ProductNDC>69238-1061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desipramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Desipramine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160321</StartMarketingDate>
<EndMarketingDate>20271231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208105</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160321</StartMarketingDatePackage>
<EndMarketingDatePackage>20271231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desipramine hydrochloride tablets are indicated for the treatment of depression.</IndicationAndUsage>
<Description>Desipramine hydrochloride tablets, USP are an antidepressant drug of the tricyclic type, and is chemically: 5H-Dibenz[bƒ]azepine-5-propanamine,10,11-dihydro-N-methyl-, monohydrochloride. Each desipramine hydrochloride tablet, USP contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride, USP for oral administration. Inactive IngredientsDesipramine hydrochloride tablets, USP contain the following inactive ingredients: corn starch, D&C Red #27 aluminum lake (in 75 mg), FD&C Blue #1 aluminum lake (in 10 mg and 50 mg), FD&C Blue #2 aluminum lake (in 10 mg), FD&C Red #40 aluminum lake (in 75 mg), FD&C Yellow #6 aluminum lake (in 50 mg, 75 mg and 100 mg), hydroxypropyl cellulose, hypromellose, iron oxide red (in 100 mg), iron oxide yellow (in 25 mg and 50 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>69238-1100-3</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE (69238-1100-3) </PackageDescription>
<NDC11Code>69238-1100-03</NDC11Code>
<ProductNDC>69238-1100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207289</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69238-1104-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (69238-1104-3) </PackageDescription>
<NDC11Code>69238-1104-03</NDC11Code>
<ProductNDC>69238-1104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiagabine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tiagabine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208181</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>TIAGABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tiagabine hydrochloride tablets are indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.</IndicationAndUsage>
<Description>Tiagabine Hydrochloride tablets are an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C20H25NO2S2 HCl, and its molecular weight is 412.0. Tiagabine HCl, USP is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>69238-1105-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (69238-1105-3) </PackageDescription>
<NDC11Code>69238-1105-03</NDC11Code>
<ProductNDC>69238-1105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiagabine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tiagabine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208181</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>TIAGABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tiagabine hydrochloride tablets are indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.</IndicationAndUsage>
<Description>Tiagabine Hydrochloride tablets are an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C20H25NO2S2 HCl, and its molecular weight is 412.0. Tiagabine HCl, USP is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>69238-1106-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (69238-1106-3) </PackageDescription>
<NDC11Code>69238-1106-03</NDC11Code>
<ProductNDC>69238-1106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiagabine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tiagabine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208181</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>TIAGABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tiagabine hydrochloride tablets are indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.</IndicationAndUsage>
<Description>Tiagabine Hydrochloride tablets are an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C20H25NO2S2 HCl, and its molecular weight is 412.0. Tiagabine HCl, USP is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>69238-1107-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (69238-1107-3) </PackageDescription>
<NDC11Code>69238-1107-03</NDC11Code>
<ProductNDC>69238-1107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiagabine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tiagabine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208181</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>TIAGABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tiagabine hydrochloride tablets are indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.</IndicationAndUsage>
<Description>Tiagabine Hydrochloride tablets are an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C20H25NO2S2 HCl, and its molecular weight is 412.0. Tiagabine HCl, USP is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base. The structural formula is.</Description>
</NDC>
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