{
"NDC": [
{
"NDCCode": "43353-899-05",
"PackageDescription": "4200 TABLET, FILM COATED in 1 BOTTLE (43353-899-05) ",
"NDC11Code": "43353-0899-05",
"ProductNDC": "43353-899",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chantix",
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021928",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "VARENICLINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2017-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140307",
"SamplePackage": "N",
"IndicationAndUsage": "CHANTIX is indicated for use as an aid to smoking cessation treatment.",
"Description": "CHANTIX tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 ∙ C4H6O6. The chemical structure is. CHANTIX is supplied for oral administration in two strengths: a 0.5 mg capsular biconvex, white to off-white, film-coated tablet debossed with \"Pfizer\" on one side and \"CHX 0.5\" on the other side and a 1 mg capsular biconvex, light blue film-coated tablet debossed with \"Pfizer\" on one side and \"CHX 1.0\" on the other side. Each 0.5 mg CHANTIX tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg CHANTIX tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry® White (for 0.5 mg), Opadry® Blue (for 1 mg), and Opadry® Clear."
},
{
"NDCCode": "43353-124-05",
"PackageDescription": "4200 TABLET in 1 BOTTLE (43353-124-05)",
"NDC11Code": "43353-0124-05",
"ProductNDC": "43353-124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089098",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2016-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151202",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "Hydralazine Hydrochloride Tablets USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. Hydralazine hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain anhydrous lactose, FD&C yellow no. 6 aluminum lake, microcrystalline cellulose, sodium starch glycolate, and stearic acid."
},
{
"NDCCode": "43353-205-05",
"PackageDescription": "4200 TABLET in 1 BOTTLE (43353-205-05)",
"NDC11Code": "43353-0205-05",
"ProductNDC": "43353-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090255",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2016-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160709",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE Hydrochloride Tablets USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg HydrALAZINE Hydrochloride, USP. Tablets also contain microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, FD&C Yellow #6 and stearic acid."
},
{
"NDCCode": "43353-917-05",
"PackageDescription": "4200 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-917-05) ",
"NDC11Code": "43353-0917-05",
"ProductNDC": "43353-917",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosorbide Mononitrate",
"NonProprietaryName": "Isosorbide Mononitrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19981030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075155",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ISOSORBIDE MONONITRATE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20140406",
"SamplePackage": "N",
"IndicationAndUsage": "Isosorbide Mononitrate Extended-Release Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
"Description": "Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc. The molecular formula of ISMN is C6H9NO6 and the molecular weight is 191.14. The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula. ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane."
},
{
"NDCCode": "43353-947-05",
"PackageDescription": "4200 CAPSULE in 1 BOTTLE, PLASTIC (43353-947-05)",
"NDC11Code": "43353-0947-05",
"ProductNDC": "43353-947",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amantadine Hydrochloride",
"NonProprietaryName": "Amantadine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19870218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071293",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "AMANTADINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.",
"Description": "Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H18NCl. It has the following structural formula. Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine hydrochloride is available as 100 mg capsules for oral administration. Inactive ingredients: corn starch, croscarmellose sodium, ethylcellulose, FD&C Blue #1, FD&C Red #40, gelatin, magnesium stearate, methylparaben, microcrystalline cellulose, pregelatinized starch, propylparaben, sodium lauryl sulfate and titanium dioxide."
},
{
"NDCCode": "43353-984-05",
"PackageDescription": "4200 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43353-984-05)",
"NDC11Code": "43353-0984-05",
"ProductNDC": "43353-984",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Galantamine Hydrobromide",
"NonProprietaryName": "Galantamine Hydrobromide",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20091215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079028",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "GALANTAMINE HYDROBROMIDE",
"StrengthNumber": "16",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"IndicationAndUsage": "Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.",
"Description": "Galantamine hydrobromide is a reversible, competitive acetylcholinesterase inhibitor. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has a molecular formula of C17H21NO3HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is. Galantamine hydrobromide extended-release capsules are available in opaque hard gelatin extended-release capsules of 8 mg (white), 16 mg (pink and white), and 24 mg (pink) containing galantamine hydrobromide, equivalent to respectively 8, 16 and 24 mg galantamine base. Inactive ingredients include gelatin, hydroxypropyl cellulose, magnesium stearate, colloidal silicon dioxide and titanium dioxide. The 16 mg capsule and 24 mg capsule also contain red ferric oxide."
},
{
"NDCCode": "43353-996-05",
"PackageDescription": "4200 TABLET, FILM COATED in 1 BOTTLE (43353-996-05) ",
"NDC11Code": "43353-0996-05",
"ProductNDC": "43353-996",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Entacapone",
"NonProprietaryName": "Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020796",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ENTACAPONE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150214",
"SamplePackage": "N",
"IndicationAndUsage": "Entacapone Tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose \"wearing-off\" in patients with Parkinson's disease (see CLINICAL PHARMACOLOGY, Clinical Studies). Entacapone Tablets' effectiveness has not been systematically evaluated in patients with Parkinson's disease who do not experience end-of-dose \"wearing-off\".",
"Description": "Entacapone is available as tablets containing 200 mg entacapone. Entacapone is an inhibitor of catechol-O-methyltransferase (COMT), used in the treatment of Parkinson's disease as an adjunct to levodopa and carbidopa therapy. It is a nitrocatechol-structured compound with a relative molecular mass of 305.29. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. The inactive ingredients of the Entacapone Tablets are microcrystalline cellulose, mannitol, croscarmellose sodium, hydrogenated vegetable oil, hydroxypropyl methylcellulose, polysorbate 80, glycerol 85%, sucrose, magnesium stearate, yellow iron oxide, red iron oxide, and titanium dioxide."
},
{
"NDCCode": "15338-899-05",
"PackageDescription": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (15338-899-05) > 1 TABLET in 1 BLISTER PACK (15338-899-11) ",
"NDC11Code": "15338-0899-05",
"ProductNDC": "15338-899",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170724",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Apace Packaging, LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170724",
"SamplePackage": "N"
},
{
"NDCCode": "23155-899-05",
"PackageDescription": "500 CAPSULE, LIQUID FILLED in 1 BOTTLE (23155-899-05) ",
"NDC11Code": "23155-0899-05",
"ProductNDC": "23155-899",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20240929",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040682",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240929",
"SamplePackage": "N",
"IndicationAndUsage": "Benzonatate is indicated for the symptomatic relief of cough.",
"Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Benzonatate Capsules, USP contain 100 mg or 200 mg of benzonatate, USP. Benzonatate Capsules also contain: D&C Yellow No. 10, gelatin, glycerin, methylparaben sodium and propylparaben sodium. The white imprinting ink contains the following inactive ingredients: ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac glaze, simethicone and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "59651-899-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (59651-899-05) ",
"NDC11Code": "59651-0899-05",
"ProductNDC": "59651-899",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250711",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078619",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250711",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "60429-899-05",
"PackageDescription": "500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (60429-899-05) ",
"NDC11Code": "60429-0899-05",
"ProductNDC": "60429-899",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20170710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075347",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170710",
"SamplePackage": "N"
},
{
"NDCCode": "68382-899-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (68382-899-05) ",
"NDC11Code": "68382-0899-05",
"ProductNDC": "68382-899",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206693",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190327",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C22H19N3O4 representing a molecular weight of 389.4. The structural formula is. The chemical designation is pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. Tadalafil, USP is white or almost white powder that is practically insoluble in water, freely soluble in dimethyl sulfoxide and slightly soluble in methylene chloride. Each Tadalafil Tablet, USP for oral administration contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and triacetin. Additionally tadalafil tablets of 5 mg, 10 mg and 20 mg also contain iron oxide yellow."
},
{
"NDCCode": "68428-899-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-899-05)",
"NDC11Code": "68428-0899-05",
"ProductNDC": "68428-899",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Brassica Napas",
"NonProprietaryName": "Brassica Napus Subsp. Napus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150710",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "BRASSICA NAPUS SUBSP. NAPUS",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-22",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "69097-899-05",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (69097-899-05) ",
"NDC11Code": "69097-0899-05",
"ProductNDC": "69097-899",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205519",
"LabelerName": "Cipla USA Inc.,",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2018-03-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160804",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*,R*)]-2-(4-fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1).The empirical formula of atorvastatin calcium is C66H68 Ca F2N4O10 and its molecular weight is 1155.36. Its structural formula is. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: anhydrous lactose, NF; colloidal silicon dioxide, NF; copovidone, NF; croscarmellose sodium, NF; magnesium stearate, NF; mannitol, USP; silicified microcrystalline cellulose, NF; sodium bicarbonate, USP; sodium carbonate anhydrous, NF; sodium lauryl sulfate, NF; lecitihin, polyvinyl alcohol part hydrolyzed, talc, titanium dioxide, xanthan gum and iron oxide yellow."
},
{
"NDCCode": "82907-899-05",
"PackageDescription": "5 g in 1 BOTTLE (82907-899-05) ",
"NDC11Code": "82907-0899-05",
"ProductNDC": "82907-899",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Hexarelin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Hangzhou Sinodo Pharm Technology Co.,Ltd",
"SubstanceName": "EXAMORELIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "12-SEP-23"
},
{
"NDCCode": "84682-899-05",
"PackageDescription": "100 g in 1 BOX (84682-899-05) ",
"NDC11Code": "84682-0899-05",
"ProductNDC": "84682-899",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vitamin C Potent Nourish Skin White",
"NonProprietaryName": "Vitamin C Potent Nourish Skin White",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "16714-899-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (16714-899-01) > 30 TABLET in 1 BOTTLE",
"NDC11Code": "16714-0899-01",
"ProductNDC": "16714-899",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fexofenadine Hcl",
"NonProprietaryName": "Fexofenadine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204097",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2019-05-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190218",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. § runny nose. § sneezing. § itchy, watery eyes. § itching of the nose or throat."
},
{
"NDCCode": "16714-899-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (16714-899-02) > 100 TABLET in 1 BOTTLE",
"NDC11Code": "16714-0899-02",
"ProductNDC": "16714-899",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fexofenadine Hcl",
"NonProprietaryName": "Fexofenadine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204097",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2019-05-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190218",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. § runny nose. § sneezing. § itchy, watery eyes. § itching of the nose or throat."
},
{
"NDCCode": "49884-899-11",
"PackageDescription": "30 POUCH in 1 CARTON (49884-899-11) / 1 TABLET in 1 POUCH (49884-899-52) ",
"NDC11Code": "49884-0899-11",
"ProductNDC": "49884-899",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate Sublingual",
"NonProprietaryName": "Zolpidem Tartrate Sublingual",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20170911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204229",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "3.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170911",
"SamplePackage": "N",
"IndicationAndUsage": "Zolpidem tartrate sublingual tablets are indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Limitations of Use: Zolpidem tartrate sublingual tablets are not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.",
"Description": "Zolpidem tartrate sublingual tablets contain zolpidem tartrate, USP a non-benzodiazepine hypnotic of the imidazopyridine class. Zolpidem tartrate sublingual tablets are available in 1.75 mg and 3.5 mg strength tablets for sublingual administration. Zolpidem tartrate sublingual tablets are intended to be placed under the tongue where they will disintegrate. Chemically, zolpidem tartrate, USP is N,N-6-trimethyl-2-p-tolylimidazo[1,2-α]pyridine-3-acetamide L-(+)-tartrate (2:1). Zolpidem tartrate, USP is a white or almost white, crystalline, hygroscopic powder that is slightly soluble in water, sparingly soluble in methanol and practically insoluble in methylene chloride. It has a molecular weight of 764.9. Each zolpidem tartrate sublingual tablet includes the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, pregelatinized starch, mannitol, peppermint flavor, saccharin sodium and corn starch."
},
{
"NDCCode": "63739-899-10",
"PackageDescription": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-899-10) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "63739-0899-10",
"ProductNDC": "63739-899",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076733",
"LabelerName": "McKesson Corporation",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-05-29",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "69842-899-16",
"PackageDescription": "16 BLISTER PACK in 1 CARTON (69842-899-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "69842-0899-16",
"ProductNDC": "69842-899",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Night Time Cold And Flu Relief",
"ProprietaryNameSuffix": "Multi Symptom",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20190731",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "325; 15; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190731",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold and flu symptoms:sore throat headache minor aches and pains fever runny nose and sneezing cough due to minor throat and bronchial irritation."
},
{
"NDCCode": "69842-899-24",
"PackageDescription": "24 BLISTER PACK in 1 CARTON (69842-899-24) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "69842-0899-24",
"ProductNDC": "69842-899",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Night Time Cold And Flu Relief",
"ProprietaryNameSuffix": "Multi Symptom",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20190731",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "325; 15; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190731",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold and flu symptoms:sore throat headache minor aches and pains fever runny nose and sneezing cough due to minor throat and bronchial irritation."
},
{
"NDCCode": "69842-899-48",
"PackageDescription": "48 BLISTER PACK in 1 CARTON (69842-899-48) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "69842-0899-48",
"ProductNDC": "69842-899",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Night Time Cold And Flu Relief",
"ProprietaryNameSuffix": "Multi Symptom",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20190731",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "325; 15; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190731",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold and flu symptoms:sore throat headache minor aches and pains fever runny nose and sneezing cough due to minor throat and bronchial irritation."
},
{
"NDCCode": "79903-899-70",
"PackageDescription": "700 mL in 1 BOTTLE, PLASTIC (79903-899-70) ",
"NDC11Code": "79903-0899-70",
"ProductNDC": "79903-899",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Walmart",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "LOTION/SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221104",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Wal-Mart Stores, Inc",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "300",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221104",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves itching , redness and flakes associated with Dandruff."
},
{
"NDCCode": "43353-017-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (43353-017-30)",
"NDC11Code": "43353-0017-30",
"ProductNDC": "43353-017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960412",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040157",
"LabelerName": "Aphena Pharma Solutions - Tennessee, Inc.",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "750; 7.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2014-05-12"
},
{
"NDCCode": "43353-017-75",
"PackageDescription": "150 TABLET in 1 BOTTLE, PLASTIC (43353-017-75)",
"NDC11Code": "43353-0017-75",
"ProductNDC": "43353-017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960412",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040157",
"LabelerName": "Aphena Pharma Solutions - Tennessee, Inc.",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "750; 7.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2014-05-12"
},
{
"NDCCode": "43353-025-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-025-30) ",
"NDC11Code": "43353-0025-30",
"ProductNDC": "43353-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20140611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203088",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150425",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS∙HCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, 40 or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide. The 30 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, and FD&C Yellow No. 10. The 40 mg hard gelatin capsule colorants are FD&C Blue No. 2, red iron oxide, and yellow iron oxide. The 60 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, FD&C Yellow No.10, and yellow iron oxide."
},
{
"NDCCode": "43353-025-60",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-025-60) ",
"NDC11Code": "43353-0025-60",
"ProductNDC": "43353-025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20140611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203088",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150425",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS∙HCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, 40 or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide. The 30 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, and FD&C Yellow No. 10. The 40 mg hard gelatin capsule colorants are FD&C Blue No. 2, red iron oxide, and yellow iron oxide. The 60 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, FD&C Yellow No.10, and yellow iron oxide."
},
{
"NDCCode": "43353-106-16",
"PackageDescription": "6000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-106-16) ",
"NDC11Code": "43353-0106-16",
"ProductNDC": "43353-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20140611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203088",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190416",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS∙HCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, 40 or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide. The 30 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, and FD&C Yellow No. 10. The 40 mg hard gelatin capsule colorants are FD&C Blue No. 2, red iron oxide, and yellow iron oxide. The 60 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, FD&C Yellow No.10, and yellow iron oxide."
},
{
"NDCCode": "43353-106-33",
"PackageDescription": "840 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-106-33) ",
"NDC11Code": "43353-0106-33",
"ProductNDC": "43353-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"ProprietaryNameSuffix": "Delayed-release",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20140611",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203088",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240408",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS∙HCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, 40 or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide. The 30 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, and FD&C Yellow No. 10. The 40 mg hard gelatin capsule colorants are FD&C Blue No. 2, red iron oxide, and yellow iron oxide. The 60 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, FD&C Yellow No.10, and yellow iron oxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>43353-899-05</NDCCode>
<PackageDescription>4200 TABLET, FILM COATED in 1 BOTTLE (43353-899-05) </PackageDescription>
<NDC11Code>43353-0899-05</NDC11Code>
<ProductNDC>43353-899</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chantix</ProprietaryName>
<NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021928</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>VARENICLINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2017-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CHANTIX is indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>CHANTIX tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 ∙ C4H6O6. The chemical structure is. CHANTIX is supplied for oral administration in two strengths: a 0.5 mg capsular biconvex, white to off-white, film-coated tablet debossed with "Pfizer" on one side and "CHX 0.5" on the other side and a 1 mg capsular biconvex, light blue film-coated tablet debossed with "Pfizer" on one side and "CHX 1.0" on the other side. Each 0.5 mg CHANTIX tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg CHANTIX tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry® White (for 0.5 mg), Opadry® Blue (for 1 mg), and Opadry® Clear.</Description>
</NDC>
<NDC>
<NDCCode>43353-124-05</NDCCode>
<PackageDescription>4200 TABLET in 1 BOTTLE (43353-124-05)</PackageDescription>
<NDC11Code>43353-0124-05</NDC11Code>
<ProductNDC>43353-124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089098</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2016-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>Hydralazine Hydrochloride Tablets USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. Hydralazine hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain anhydrous lactose, FD&C yellow no. 6 aluminum lake, microcrystalline cellulose, sodium starch glycolate, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>43353-205-05</NDCCode>
<PackageDescription>4200 TABLET in 1 BOTTLE (43353-205-05)</PackageDescription>
<NDC11Code>43353-0205-05</NDC11Code>
<ProductNDC>43353-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090255</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2016-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE Hydrochloride Tablets USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg HydrALAZINE Hydrochloride, USP. Tablets also contain microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, FD&C Yellow #6 and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>43353-917-05</NDCCode>
<PackageDescription>4200 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-917-05) </PackageDescription>
<NDC11Code>43353-0917-05</NDC11Code>
<ProductNDC>43353-917</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
<NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075155</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isosorbide Mononitrate Extended-Release Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
<Description>Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc. The molecular formula of ISMN is C6H9NO6 and the molecular weight is 191.14. The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula. ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane.</Description>
</NDC>
<NDC>
<NDCCode>43353-947-05</NDCCode>
<PackageDescription>4200 CAPSULE in 1 BOTTLE, PLASTIC (43353-947-05)</PackageDescription>
<NDC11Code>43353-0947-05</NDC11Code>
<ProductNDC>43353-947</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amantadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19870218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071293</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.</IndicationAndUsage>
<Description>Amantadine hydrochloride is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H18NCl. It has the following structural formula. Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine hydrochloride is available as 100 mg capsules for oral administration. Inactive ingredients: corn starch, croscarmellose sodium, ethylcellulose, FD&C Blue #1, FD&C Red #40, gelatin, magnesium stearate, methylparaben, microcrystalline cellulose, pregelatinized starch, propylparaben, sodium lauryl sulfate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43353-984-05</NDCCode>
<PackageDescription>4200 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43353-984-05)</PackageDescription>
<NDC11Code>43353-0984-05</NDC11Code>
<ProductNDC>43353-984</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Galantamine Hydrobromide</ProprietaryName>
<NonProprietaryName>Galantamine Hydrobromide</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079028</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Galantamine hydrobromide is a reversible, competitive acetylcholinesterase inhibitor. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has a molecular formula of C17H21NO3HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is. Galantamine hydrobromide extended-release capsules are available in opaque hard gelatin extended-release capsules of 8 mg (white), 16 mg (pink and white), and 24 mg (pink) containing galantamine hydrobromide, equivalent to respectively 8, 16 and 24 mg galantamine base. Inactive ingredients include gelatin, hydroxypropyl cellulose, magnesium stearate, colloidal silicon dioxide and titanium dioxide. The 16 mg capsule and 24 mg capsule also contain red ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>43353-996-05</NDCCode>
<PackageDescription>4200 TABLET, FILM COATED in 1 BOTTLE (43353-996-05) </PackageDescription>
<NDC11Code>43353-0996-05</NDC11Code>
<ProductNDC>43353-996</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Entacapone</ProprietaryName>
<NonProprietaryName>Entacapone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120930</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020796</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ENTACAPONE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Entacapone Tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose "wearing-off" in patients with Parkinson's disease (see CLINICAL PHARMACOLOGY, Clinical Studies). Entacapone Tablets' effectiveness has not been systematically evaluated in patients with Parkinson's disease who do not experience end-of-dose "wearing-off".</IndicationAndUsage>
<Description>Entacapone is available as tablets containing 200 mg entacapone. Entacapone is an inhibitor of catechol-O-methyltransferase (COMT), used in the treatment of Parkinson's disease as an adjunct to levodopa and carbidopa therapy. It is a nitrocatechol-structured compound with a relative molecular mass of 305.29. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. The inactive ingredients of the Entacapone Tablets are microcrystalline cellulose, mannitol, croscarmellose sodium, hydrogenated vegetable oil, hydroxypropyl methylcellulose, polysorbate 80, glycerol 85%, sucrose, magnesium stearate, yellow iron oxide, red iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>15338-899-05</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX, UNIT-DOSE (15338-899-05) > 1 TABLET in 1 BLISTER PACK (15338-899-11) </PackageDescription>
<NDC11Code>15338-0899-05</NDC11Code>
<ProductNDC>15338-899</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Apace Packaging, LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>23155-899-05</NDCCode>
<PackageDescription>500 CAPSULE, LIQUID FILLED in 1 BOTTLE (23155-899-05) </PackageDescription>
<NDC11Code>23155-0899-05</NDC11Code>
<ProductNDC>23155-899</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040682</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7. Benzonatate Capsules, USP contain 100 mg or 200 mg of benzonatate, USP. Benzonatate Capsules also contain: D&C Yellow No. 10, gelatin, glycerin, methylparaben sodium and propylparaben sodium. The white imprinting ink contains the following inactive ingredients: ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac glaze, simethicone and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>59651-899-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (59651-899-05) </PackageDescription>
<NDC11Code>59651-0899-05</NDC11Code>
<ProductNDC>59651-899</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250711</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078619</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of. Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of. Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>60429-899-05</NDCCode>
<PackageDescription>500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (60429-899-05) </PackageDescription>
<NDC11Code>60429-0899-05</NDC11Code>
<ProductNDC>60429-899</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075347</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-899-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (68382-899-05) </PackageDescription>
<NDC11Code>68382-0899-05</NDC11Code>
<ProductNDC>68382-899</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206693</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C22H19N3O4 representing a molecular weight of 389.4. The structural formula is. The chemical designation is pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. Tadalafil, USP is white or almost white powder that is practically insoluble in water, freely soluble in dimethyl sulfoxide and slightly soluble in methylene chloride. Each Tadalafil Tablet, USP for oral administration contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and triacetin. Additionally tadalafil tablets of 5 mg, 10 mg and 20 mg also contain iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>68428-899-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-899-05)</PackageDescription>
<NDC11Code>68428-0899-05</NDC11Code>
<ProductNDC>68428-899</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Brassica Napas</ProprietaryName>
<NonProprietaryName>Brassica Napus Subsp. Napus</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150710</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>BRASSICA NAPUS SUBSP. NAPUS</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-22</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69097-899-05</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (69097-899-05) </PackageDescription>
<NDC11Code>69097-0899-05</NDC11Code>
<ProductNDC>69097-899</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205519</ApplicationNumber>
<LabelerName>Cipla USA Inc.,</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-03-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*,R*)]-2-(4-fluorophenyl)-ß,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1).The empirical formula of atorvastatin calcium is C66H68 Ca F2N4O10 and its molecular weight is 1155.36. Its structural formula is. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: anhydrous lactose, NF; colloidal silicon dioxide, NF; copovidone, NF; croscarmellose sodium, NF; magnesium stearate, NF; mannitol, USP; silicified microcrystalline cellulose, NF; sodium bicarbonate, USP; sodium carbonate anhydrous, NF; sodium lauryl sulfate, NF; lecitihin, polyvinyl alcohol part hydrolyzed, talc, titanium dioxide, xanthan gum and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>82907-899-05</NDCCode>
<PackageDescription>5 g in 1 BOTTLE (82907-899-05) </PackageDescription>
<NDC11Code>82907-0899-05</NDC11Code>
<ProductNDC>82907-899</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Hexarelin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Hangzhou Sinodo Pharm Technology Co.,Ltd</LabelerName>
<SubstanceName>EXAMORELIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>12-SEP-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>84682-899-05</NDCCode>
<PackageDescription>100 g in 1 BOX (84682-899-05) </PackageDescription>
<NDC11Code>84682-0899-05</NDC11Code>
<ProductNDC>84682-899</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vitamin C Potent Nourish Skin White</ProprietaryName>
<NonProprietaryName>Vitamin C Potent Nourish Skin White</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-899-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (16714-899-01) > 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>16714-0899-01</NDC11Code>
<ProductNDC>16714-899</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fexofenadine Hcl</ProprietaryName>
<NonProprietaryName>Fexofenadine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204097</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-05-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. § runny nose. § sneezing. § itchy, watery eyes. § itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-899-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (16714-899-02) > 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>16714-0899-02</NDC11Code>
<ProductNDC>16714-899</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fexofenadine Hcl</ProprietaryName>
<NonProprietaryName>Fexofenadine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204097</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-05-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies. § runny nose. § sneezing. § itchy, watery eyes. § itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49884-899-11</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (49884-899-11) / 1 TABLET in 1 POUCH (49884-899-52) </PackageDescription>
<NDC11Code>49884-0899-11</NDC11Code>
<ProductNDC>49884-899</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate Sublingual</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate Sublingual</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20170911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204229</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>3.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolpidem tartrate sublingual tablets are indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Limitations of Use: Zolpidem tartrate sublingual tablets are not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.</IndicationAndUsage>
<Description>Zolpidem tartrate sublingual tablets contain zolpidem tartrate, USP a non-benzodiazepine hypnotic of the imidazopyridine class. Zolpidem tartrate sublingual tablets are available in 1.75 mg and 3.5 mg strength tablets for sublingual administration. Zolpidem tartrate sublingual tablets are intended to be placed under the tongue where they will disintegrate. Chemically, zolpidem tartrate, USP is N,N-6-trimethyl-2-p-tolylimidazo[1,2-α]pyridine-3-acetamide L-(+)-tartrate (2:1). Zolpidem tartrate, USP is a white or almost white, crystalline, hygroscopic powder that is slightly soluble in water, sparingly soluble in methanol and practically insoluble in methylene chloride. It has a molecular weight of 764.9. Each zolpidem tartrate sublingual tablet includes the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, pregelatinized starch, mannitol, peppermint flavor, saccharin sodium and corn starch.</Description>
</NDC>
<NDC>
<NDCCode>63739-899-10</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-899-10) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63739-0899-10</NDC11Code>
<ProductNDC>63739-899</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076733</ApplicationNumber>
<LabelerName>McKesson Corporation</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-29</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69842-899-16</NDCCode>
<PackageDescription>16 BLISTER PACK in 1 CARTON (69842-899-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69842-0899-16</NDC11Code>
<ProductNDC>69842-899</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Night Time Cold And Flu Relief</ProprietaryName>
<ProprietaryNameSuffix>Multi Symptom</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190731</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>325; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold and flu symptoms:sore throat headache minor aches and pains fever runny nose and sneezing cough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69842-899-24</NDCCode>
<PackageDescription>24 BLISTER PACK in 1 CARTON (69842-899-24) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69842-0899-24</NDC11Code>
<ProductNDC>69842-899</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Night Time Cold And Flu Relief</ProprietaryName>
<ProprietaryNameSuffix>Multi Symptom</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190731</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>325; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold and flu symptoms:sore throat headache minor aches and pains fever runny nose and sneezing cough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69842-899-48</NDCCode>
<PackageDescription>48 BLISTER PACK in 1 CARTON (69842-899-48) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69842-0899-48</NDC11Code>
<ProductNDC>69842-899</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Night Time Cold And Flu Relief</ProprietaryName>
<ProprietaryNameSuffix>Multi Symptom</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190731</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>325; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold and flu symptoms:sore throat headache minor aches and pains fever runny nose and sneezing cough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79903-899-70</NDCCode>
<PackageDescription>700 mL in 1 BOTTLE, PLASTIC (79903-899-70) </PackageDescription>
<NDC11Code>79903-0899-70</NDC11Code>
<ProductNDC>79903-899</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Walmart</ProprietaryName>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>LOTION/SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Wal-Mart Stores, Inc</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves itching , redness and flakes associated with Dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43353-017-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (43353-017-30)</PackageDescription>
<NDC11Code>43353-0017-30</NDC11Code>
<ProductNDC>43353-017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960412</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040157</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>750; 7.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-05-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>43353-017-75</NDCCode>
<PackageDescription>150 TABLET in 1 BOTTLE, PLASTIC (43353-017-75)</PackageDescription>
<NDC11Code>43353-0017-75</NDC11Code>
<ProductNDC>43353-017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960412</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040157</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>750; 7.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-05-12</LastUpdate>
</NDC>
<NDC>
<NDCCode>43353-025-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-025-30) </PackageDescription>
<NDC11Code>43353-0025-30</NDC11Code>
<ProductNDC>43353-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203088</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS∙HCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, 40 or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide. The 30 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, and FD&C Yellow No. 10. The 40 mg hard gelatin capsule colorants are FD&C Blue No. 2, red iron oxide, and yellow iron oxide. The 60 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, FD&C Yellow No.10, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>43353-025-60</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-025-60) </PackageDescription>
<NDC11Code>43353-0025-60</NDC11Code>
<ProductNDC>43353-025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203088</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS∙HCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, 40 or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide. The 30 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, and FD&C Yellow No. 10. The 40 mg hard gelatin capsule colorants are FD&C Blue No. 2, red iron oxide, and yellow iron oxide. The 60 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, FD&C Yellow No.10, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>43353-106-16</NDCCode>
<PackageDescription>6000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-106-16) </PackageDescription>
<NDC11Code>43353-0106-16</NDC11Code>
<ProductNDC>43353-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203088</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS∙HCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, 40 or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide. The 30 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, and FD&C Yellow No. 10. The 40 mg hard gelatin capsule colorants are FD&C Blue No. 2, red iron oxide, and yellow iron oxide. The 60 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, FD&C Yellow No.10, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>43353-106-33</NDCCode>
<PackageDescription>840 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-106-33) </PackageDescription>
<NDC11Code>43353-0106-33</NDC11Code>
<ProductNDC>43353-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
<ProprietaryNameSuffix>Delayed-release</ProprietaryNameSuffix>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140611</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203088</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S)- N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS∙HCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, 40 or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide. The 30 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, and FD&C Yellow No. 10. The 40 mg hard gelatin capsule colorants are FD&C Blue No. 2, red iron oxide, and yellow iron oxide. The 60 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, FD&C Yellow No.10, and yellow iron oxide.</Description>
</NDC>
</NDCList>