{
"NDC": [
{
"NDCCode": "68382-653-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (68382-653-06) ",
"NDC11Code": "68382-0653-06",
"ProductNDC": "68382-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyburide And Metformin Hydrochloride",
"NonProprietaryName": "Glyburide And Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206748",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "GLYBURIDE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1.25; 250",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160407",
"SamplePackage": "N",
"IndicationAndUsage": "Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide, USP and metformin hydrochloride, USP. Glyburide, USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide, USP is a white or almost white, crystalline powder with a molecular formula of C23H28ClN3O5S and a molecular weight of 494. The glyburide used in glyburide and metformin hydrochloride tablets, USP has a particle size at least 20% are less than 2 micron, at least 80% are less than 10 micron and 100% are less than 40 micron. The structural formula is represented below. Metformin hydrochloride, USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white crystals with a molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.62. Metformin hydrochloride, USP is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The structural formula is as shown. Glyburide and metformin hydrochloride tablets, USP are available in film coated tablets containing: 1 1.25 mg glyburide, USP and 250 mg metformin hydrochloride, USP (equivalent to 194.97 mg metformin);, 2 2.5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin);, 3 5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin)."
},
{
"NDCCode": "68382-653-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (68382-653-01) ",
"NDC11Code": "68382-0653-01",
"ProductNDC": "68382-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyburide And Metformin Hydrochloride",
"NonProprietaryName": "Glyburide And Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206748",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "GLYBURIDE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1.25; 250",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160407",
"SamplePackage": "N",
"IndicationAndUsage": "Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide, USP and metformin hydrochloride, USP. Glyburide, USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide, USP is a white or almost white, crystalline powder with a molecular formula of C23H28ClN3O5S and a molecular weight of 494. The glyburide used in glyburide and metformin hydrochloride tablets, USP has a particle size at least 20% are less than 2 micron, at least 80% are less than 10 micron and 100% are less than 40 micron. The structural formula is represented below. Metformin hydrochloride, USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white crystals with a molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.62. Metformin hydrochloride, USP is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The structural formula is as shown. Glyburide and metformin hydrochloride tablets, USP are available in film coated tablets containing: 1 1.25 mg glyburide, USP and 250 mg metformin hydrochloride, USP (equivalent to 194.97 mg metformin);, 2 2.5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin);, 3 5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin)."
},
{
"NDCCode": "68382-653-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (68382-653-05) ",
"NDC11Code": "68382-0653-05",
"ProductNDC": "68382-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyburide And Metformin Hydrochloride",
"NonProprietaryName": "Glyburide And Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206748",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "GLYBURIDE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1.25; 250",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160407",
"SamplePackage": "N",
"IndicationAndUsage": "Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide, USP and metformin hydrochloride, USP. Glyburide, USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide, USP is a white or almost white, crystalline powder with a molecular formula of C23H28ClN3O5S and a molecular weight of 494. The glyburide used in glyburide and metformin hydrochloride tablets, USP has a particle size at least 20% are less than 2 micron, at least 80% are less than 10 micron and 100% are less than 40 micron. The structural formula is represented below. Metformin hydrochloride, USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white crystals with a molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.62. Metformin hydrochloride, USP is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The structural formula is as shown. Glyburide and metformin hydrochloride tablets, USP are available in film coated tablets containing: 1 1.25 mg glyburide, USP and 250 mg metformin hydrochloride, USP (equivalent to 194.97 mg metformin);, 2 2.5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin);, 3 5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin)."
},
{
"NDCCode": "68382-653-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (68382-653-10) ",
"NDC11Code": "68382-0653-10",
"ProductNDC": "68382-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyburide And Metformin Hydrochloride",
"NonProprietaryName": "Glyburide And Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206748",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "GLYBURIDE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1.25; 250",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160407",
"SamplePackage": "N",
"IndicationAndUsage": "Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide, USP and metformin hydrochloride, USP. Glyburide, USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide, USP is a white or almost white, crystalline powder with a molecular formula of C23H28ClN3O5S and a molecular weight of 494. The glyburide used in glyburide and metformin hydrochloride tablets, USP has a particle size at least 20% are less than 2 micron, at least 80% are less than 10 micron and 100% are less than 40 micron. The structural formula is represented below. Metformin hydrochloride, USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white crystals with a molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.62. Metformin hydrochloride, USP is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The structural formula is as shown. Glyburide and metformin hydrochloride tablets, USP are available in film coated tablets containing: 1 1.25 mg glyburide, USP and 250 mg metformin hydrochloride, USP (equivalent to 194.97 mg metformin);, 2 2.5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin);, 3 5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin)."
},
{
"NDCCode": "68382-653-16",
"PackageDescription": "90 TABLET in 1 BOTTLE (68382-653-16) ",
"NDC11Code": "68382-0653-16",
"ProductNDC": "68382-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyburide And Metformin Hydrochloride",
"NonProprietaryName": "Glyburide And Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206748",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "GLYBURIDE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1.25; 250",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160407",
"SamplePackage": "N",
"IndicationAndUsage": "Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide, USP and metformin hydrochloride, USP. Glyburide, USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide, USP is a white or almost white, crystalline powder with a molecular formula of C23H28ClN3O5S and a molecular weight of 494. The glyburide used in glyburide and metformin hydrochloride tablets, USP has a particle size at least 20% are less than 2 micron, at least 80% are less than 10 micron and 100% are less than 40 micron. The structural formula is represented below. Metformin hydrochloride, USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white crystals with a molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.62. Metformin hydrochloride, USP is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The structural formula is as shown. Glyburide and metformin hydrochloride tablets, USP are available in film coated tablets containing: 1 1.25 mg glyburide, USP and 250 mg metformin hydrochloride, USP (equivalent to 194.97 mg metformin);, 2 2.5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin);, 3 5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin)."
},
{
"NDCCode": "68382-653-77",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68382-653-77) / 10 TABLET in 1 BLISTER PACK (68382-653-30) ",
"NDC11Code": "68382-0653-77",
"ProductNDC": "68382-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glyburide And Metformin Hydrochloride",
"NonProprietaryName": "Glyburide And Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206748",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "GLYBURIDE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1.25; 250",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160407",
"SamplePackage": "N",
"IndicationAndUsage": "Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide, USP and metformin hydrochloride, USP. Glyburide, USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide, USP is a white or almost white, crystalline powder with a molecular formula of C23H28ClN3O5S and a molecular weight of 494. The glyburide used in glyburide and metformin hydrochloride tablets, USP has a particle size at least 20% are less than 2 micron, at least 80% are less than 10 micron and 100% are less than 40 micron. The structural formula is represented below. Metformin hydrochloride, USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white crystals with a molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.62. Metformin hydrochloride, USP is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The structural formula is as shown. Glyburide and metformin hydrochloride tablets, USP are available in film coated tablets containing: 1 1.25 mg glyburide, USP and 250 mg metformin hydrochloride, USP (equivalent to 194.97 mg metformin);, 2 2.5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin);, 3 5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin)."
},
{
"NDCCode": "36800-653-06",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (36800-653-06) / 45 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "36800-0653-06",
"ProductNDC": "36800-653",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"NonProprietaryName": "Fexofenadine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211075",
"LabelerName": "TOPCO ASSOCIATES LLC",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211116",
"EndMarketingDatePackage": "20231130",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "43063-653-06",
"PackageDescription": "6 TABLET in 1 BOTTLE, PLASTIC (43063-653-06) ",
"NDC11Code": "43063-0653-06",
"ProductNDC": "43063-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone And Acetaminophen",
"NonProprietaryName": "Oxycodone And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201278",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "5; 325",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-11-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170303",
"SamplePackage": "N"
},
{
"NDCCode": "64980-653-06",
"PackageDescription": "60 TABLET in 1 BOTTLE (64980-653-06) ",
"NDC11Code": "64980-0653-06",
"ProductNDC": "64980-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075413",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260227",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling \"on edge,\" irritability, impatience.",
"Description": "Buspirone hydrochloride tablets USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white to off-white crystalline powder, very soluble in water, freely soluble in methanol, sparingly soluble in acetonitrile and practically insoluble in n-Hexane with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Buspirone hydrochloride is supplied as tablets for oral administration contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP. The 5 mg, 7.5 mg1 and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10-mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet) or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. 1Note :- Not applicable for divided doses. FDA approved dissolution test specification differ from USP."
},
{
"NDCCode": "68180-653-06",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (68180-653-06) ",
"NDC11Code": "68180-0653-06",
"ProductNDC": "68180-653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxyclycline Hyclate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171030",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208818",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20171030",
"SamplePackage": "N"
},
{
"NDCCode": "68428-653-06",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (68428-653-06) ",
"NDC11Code": "68428-0653-06",
"ProductNDC": "68428-653",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Strophanthus Hispidus",
"NonProprietaryName": "Strophanthus Hispidus Seed",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100826",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "STROPHANTHUS HISPIDUS SEED",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100826",
"SamplePackage": "N"
},
{
"NDCCode": "79939-653-06",
"PackageDescription": "20000 mL in 1 BOTTLE (79939-653-06) ",
"NDC11Code": "79939-0653-06",
"ProductNDC": "79939-653",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antiseptic Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20201019",
"EndMarketingDate": "20211019",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "FUJIMURA TRADING, S.A. DE C.V.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201019",
"EndMarketingDatePackage": "20211019",
"SamplePackage": "N"
},
{
"NDCCode": "68382-001-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68382-001-06) ",
"NDC11Code": "68382-0001-06",
"ProductNDC": "68382-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077584",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070413",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).",
"Description": "Paroxetine tablets, USP contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride, USP is an odorless, white to off-white crystalline powder, having a melting point range of 120°C to 138°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in dichloromethane and slightly soluble in water. Paroxetine tablets are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide."
},
{
"NDCCode": "68382-018-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (68382-018-06) ",
"NDC11Code": "68382-0018-06",
"ProductNDC": "68382-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077653",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-08-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080613",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder. It is soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Each venlafaxine tablet, USP intended for oral administration contains venlafaxine hydrochloride equivalent to 25 mg or 37.5 mg or 50 mg or 75 mg or 100 mg of venlafaxine. In addition, each tablet contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "68382-019-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (68382-019-06) ",
"NDC11Code": "68382-0019-06",
"ProductNDC": "68382-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077653",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-08-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080613",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder. It is soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Each venlafaxine tablet, USP intended for oral administration contains venlafaxine hydrochloride equivalent to 25 mg or 37.5 mg or 50 mg or 75 mg or 100 mg of venlafaxine. In addition, each tablet contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "68382-020-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (68382-020-06) ",
"NDC11Code": "68382-0020-06",
"ProductNDC": "68382-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077653",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-08-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080613",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder. It is soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Each venlafaxine tablet, USP intended for oral administration contains venlafaxine hydrochloride equivalent to 25 mg or 37.5 mg or 50 mg or 75 mg or 100 mg of venlafaxine. In addition, each tablet contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "68382-021-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (68382-021-06) ",
"NDC11Code": "68382-0021-06",
"ProductNDC": "68382-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077653",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-08-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080613",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.",
"Description": "Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder. It is soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Each venlafaxine tablet, USP intended for oral administration contains venlafaxine hydrochloride equivalent to 25 mg or 37.5 mg or 50 mg or 75 mg or 100 mg of venlafaxine. In addition, each tablet contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate."
},
{
"NDCCode": "68382-034-06",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-034-06) ",
"NDC11Code": "68382-0034-06",
"ProductNDC": "68382-034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090174",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2022-10-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110601",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder; soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Venlafaxine hydrochloride extended-release capsules, USP intended for oral administration contains 37.5 mg, 75 mg and 150 mg of venlafaxine. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, cetostearyl alcohol, gelatin, hypromellose, microcrystalline cellulose, polyacrylate dispersion, sodium lauryl sulfate, talc and titanium dioxide. Additionally each 37.5 mg capsule shell contains black iron oxide and each 75 mg and 150 mg capsule shell contains red iron oxide. The capsule is printed with black pharmaceutical ink which contains black iron oxide as coloring agent. The product complies with USP dissolution test 7."
},
{
"NDCCode": "68382-035-06",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-035-06) ",
"NDC11Code": "68382-0035-06",
"ProductNDC": "68382-035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090174",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2022-10-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110601",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder; soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Venlafaxine hydrochloride extended-release capsules, USP intended for oral administration contains 37.5 mg, 75 mg and 150 mg of venlafaxine. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, cetostearyl alcohol, gelatin, hypromellose, microcrystalline cellulose, polyacrylate dispersion, sodium lauryl sulfate, talc and titanium dioxide. Additionally each 37.5 mg capsule shell contains black iron oxide and each 75 mg and 150 mg capsule shell contains red iron oxide. The capsule is printed with black pharmaceutical ink which contains black iron oxide as coloring agent. The product complies with USP dissolution test 7."
},
{
"NDCCode": "68382-036-06",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-036-06) ",
"NDC11Code": "68382-0036-06",
"ProductNDC": "68382-036",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090174",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2022-10-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110601",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder; soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Venlafaxine hydrochloride extended-release capsules, USP intended for oral administration contains 37.5 mg, 75 mg and 150 mg of venlafaxine. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, cetostearyl alcohol, gelatin, hypromellose, microcrystalline cellulose, polyacrylate dispersion, sodium lauryl sulfate, talc and titanium dioxide. Additionally each 37.5 mg capsule shell contains black iron oxide and each 75 mg and 150 mg capsule shell contains red iron oxide. The capsule is printed with black pharmaceutical ink which contains black iron oxide as coloring agent. The product complies with USP dissolution test 7."
},
{
"NDCCode": "68382-043-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68382-043-06) ",
"NDC11Code": "68382-0043-06",
"ProductNDC": "68382-043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077106",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171202",
"SamplePackage": "N"
},
{
"NDCCode": "68382-044-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68382-044-06) ",
"NDC11Code": "68382-0044-06",
"ProductNDC": "68382-044",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077106",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171202",
"SamplePackage": "N"
},
{
"NDCCode": "68382-045-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68382-045-06) ",
"NDC11Code": "68382-0045-06",
"ProductNDC": "68382-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077106",
"LabelerName": "Zydus Pharmaceuticals (USA) Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171202",
"SamplePackage": "N"
},
{
"NDCCode": "68382-065-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68382-065-06) ",
"NDC11Code": "68382-0065-06",
"ProductNDC": "68382-065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077837",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20061220",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin is indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):, 3 In adults with primary hyperlipidemia., 4 In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH)., 6 As an adjunct to diet for the treatment of adults with:, 7 Primary dysbetalipoproteinemia., 8 Hypertriglyceridemia.",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white powder that is practically insoluble in water; freely soluble in chloroform, in methanol and in alcohol; sparingly soluble in propylene glycol; very slightly soluble in hexane. Each simvastatin tablet intended for oral administration contains 5 mg or 10 mg or 20 mg or 40 mg or 80 mg of simvastatin. In addition, each tablet contains following inactive ingredients: ascorbic acid, citric acid anhydrous, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, pregelatinized starch, talc and titanium dioxide. Additionally, each 10 mg tablet contains iron oxide red and iron oxide yellow, 20 mg tablet contains iron oxide black, iron oxide red and iron oxide yellow and 40 mg tablet contains iron oxide red. Butylated hydroxyanisole is added as a preservative. The botanical source for Pregelatinized starch is corn starch."
},
{
"NDCCode": "68382-066-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68382-066-06) ",
"NDC11Code": "68382-0066-06",
"ProductNDC": "68382-066",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077837",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20061220",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin is indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):, 3 In adults with primary hyperlipidemia., 4 In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH)., 6 As an adjunct to diet for the treatment of adults with:, 7 Primary dysbetalipoproteinemia., 8 Hypertriglyceridemia.",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white powder that is practically insoluble in water; freely soluble in chloroform, in methanol and in alcohol; sparingly soluble in propylene glycol; very slightly soluble in hexane. Each simvastatin tablet intended for oral administration contains 5 mg or 10 mg or 20 mg or 40 mg or 80 mg of simvastatin. In addition, each tablet contains following inactive ingredients: ascorbic acid, citric acid anhydrous, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, pregelatinized starch, talc and titanium dioxide. Additionally, each 10 mg tablet contains iron oxide red and iron oxide yellow, 20 mg tablet contains iron oxide black, iron oxide red and iron oxide yellow and 40 mg tablet contains iron oxide red. Butylated hydroxyanisole is added as a preservative. The botanical source for Pregelatinized starch is corn starch."
},
{
"NDCCode": "68382-067-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68382-067-06) ",
"NDC11Code": "68382-0067-06",
"ProductNDC": "68382-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077837",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20061220",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin is indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):, 3 In adults with primary hyperlipidemia., 4 In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH)., 6 As an adjunct to diet for the treatment of adults with:, 7 Primary dysbetalipoproteinemia., 8 Hypertriglyceridemia.",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white powder that is practically insoluble in water; freely soluble in chloroform, in methanol and in alcohol; sparingly soluble in propylene glycol; very slightly soluble in hexane. Each simvastatin tablet intended for oral administration contains 5 mg or 10 mg or 20 mg or 40 mg or 80 mg of simvastatin. In addition, each tablet contains following inactive ingredients: ascorbic acid, citric acid anhydrous, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, pregelatinized starch, talc and titanium dioxide. Additionally, each 10 mg tablet contains iron oxide red and iron oxide yellow, 20 mg tablet contains iron oxide black, iron oxide red and iron oxide yellow and 40 mg tablet contains iron oxide red. Butylated hydroxyanisole is added as a preservative. The botanical source for Pregelatinized starch is corn starch."
},
{
"NDCCode": "68382-068-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68382-068-06) ",
"NDC11Code": "68382-0068-06",
"ProductNDC": "68382-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077837",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20061220",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin is indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):, 3 In adults with primary hyperlipidemia., 4 In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH)., 6 As an adjunct to diet for the treatment of adults with:, 7 Primary dysbetalipoproteinemia., 8 Hypertriglyceridemia.",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white powder that is practically insoluble in water; freely soluble in chloroform, in methanol and in alcohol; sparingly soluble in propylene glycol; very slightly soluble in hexane. Each simvastatin tablet intended for oral administration contains 5 mg or 10 mg or 20 mg or 40 mg or 80 mg of simvastatin. In addition, each tablet contains following inactive ingredients: ascorbic acid, citric acid anhydrous, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, pregelatinized starch, talc and titanium dioxide. Additionally, each 10 mg tablet contains iron oxide red and iron oxide yellow, 20 mg tablet contains iron oxide black, iron oxide red and iron oxide yellow and 40 mg tablet contains iron oxide red. Butylated hydroxyanisole is added as a preservative. The botanical source for Pregelatinized starch is corn starch."
},
{
"NDCCode": "68382-069-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68382-069-06) ",
"NDC11Code": "68382-0069-06",
"ProductNDC": "68382-069",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077837",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20061220",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin is indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):, 3 In adults with primary hyperlipidemia., 4 In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH)., 6 As an adjunct to diet for the treatment of adults with:, 7 Primary dysbetalipoproteinemia., 8 Hypertriglyceridemia.",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white powder that is practically insoluble in water; freely soluble in chloroform, in methanol and in alcohol; sparingly soluble in propylene glycol; very slightly soluble in hexane. Each simvastatin tablet intended for oral administration contains 5 mg or 10 mg or 20 mg or 40 mg or 80 mg of simvastatin. In addition, each tablet contains following inactive ingredients: ascorbic acid, citric acid anhydrous, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, pregelatinized starch, talc and titanium dioxide. Additionally, each 10 mg tablet contains iron oxide red and iron oxide yellow, 20 mg tablet contains iron oxide black, iron oxide red and iron oxide yellow and 40 mg tablet contains iron oxide red. Butylated hydroxyanisole is added as a preservative. The botanical source for Pregelatinized starch is corn starch."
},
{
"NDCCode": "68382-074-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (68382-074-06) ",
"NDC11Code": "68382-0074-06",
"ProductNDC": "68382-074",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finasteride",
"NonProprietaryName": "Finasteride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078900",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "FINASTERIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20171205",
"SamplePackage": "N",
"IndicationAndUsage": "Finasteride tablets, are 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1): 1 Improve symptoms , 2 Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. .",
"Description": "Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-,(5α,17β)-. The molecular formula of finasteride is C23H36N2O2 and its molecular weight is 372.55. Its structural formula is:. Finasteride, USP is a white to off-white, crystalline solid which melts between 251(C and 258(C. It is freely soluble in chloroform and in alcohol. Each finasteride tablet intended for oral administration contains 5 mg of finasteride. In addition, each tablet contains the following inactive ingredients: docusate sodium, FD&C blue # 2, hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc and titanium dioxide. The tablet is printed with black pharmaceutical ink which contains following major ingredients: Shellac Glaze and black iron oxide. The starch source for sodium starch glycolate is potato starch and for Pregelatinized starch is corn starch."
},
{
"NDCCode": "68382-080-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (68382-080-06) ",
"NDC11Code": "68382-0080-06",
"ProductNDC": "68382-080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077580",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080103",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol is indicated for use in the management of manifestations of psychotic disorders. Haloperidol is indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol is effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol is also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.",
"Description": "Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone. It has the following structural formula. Each haloperidol tablet, USP intended for oral administration contains haloperidol, USP 0.5 mg or 1 mg or 2 mg or 5 mg or 10 mg or 20 mg. In addition each 0.5 mg, 1 mg, 2 mg tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize) and each 5 mg, 10 mg, 20 mg tablet contains the following inactive ingredients: calcium stearate, dibasic calcium phosphate dihydrate, povidone (PVP K 30), sodium starch glycolate and starch. 1 mg: D&C Yellow #10 Aluminium Lake, FD&C Yellow #6 Aluminium Lake; 2 mg: D & C Red #27 Aluminum Lake; 5 mg: D & C Yellow #10 Aluminum Lake and FD & C Blue #1 Aluminum Lake; 10 mg: D & C Yellow #10 Aluminum Lake and FD & C Blue #1 Aluminum Lake; 20 mg: FD & C Yellow #6 Aluminum Lake and D & C Red #27 Aluminum Lake."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>68382-653-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68382-653-06) </PackageDescription>
<NDC11Code>68382-0653-06</NDC11Code>
<ProductNDC>68382-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyburide And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Glyburide And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206748</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>GLYBURIDE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.25; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide, USP and metformin hydrochloride, USP. Glyburide, USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide, USP is a white or almost white, crystalline powder with a molecular formula of C23H28ClN3O5S and a molecular weight of 494. The glyburide used in glyburide and metformin hydrochloride tablets, USP has a particle size at least 20% are less than 2 micron, at least 80% are less than 10 micron and 100% are less than 40 micron. The structural formula is represented below. Metformin hydrochloride, USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white crystals with a molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.62. Metformin hydrochloride, USP is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The structural formula is as shown. Glyburide and metformin hydrochloride tablets, USP are available in film coated tablets containing: 1 1.25 mg glyburide, USP and 250 mg metformin hydrochloride, USP (equivalent to 194.97 mg metformin);, 2 2.5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin);, 3 5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin).</Description>
</NDC>
<NDC>
<NDCCode>68382-653-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68382-653-01) </PackageDescription>
<NDC11Code>68382-0653-01</NDC11Code>
<ProductNDC>68382-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyburide And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Glyburide And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206748</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>GLYBURIDE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.25; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide, USP and metformin hydrochloride, USP. Glyburide, USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide, USP is a white or almost white, crystalline powder with a molecular formula of C23H28ClN3O5S and a molecular weight of 494. The glyburide used in glyburide and metformin hydrochloride tablets, USP has a particle size at least 20% are less than 2 micron, at least 80% are less than 10 micron and 100% are less than 40 micron. The structural formula is represented below. Metformin hydrochloride, USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white crystals with a molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.62. Metformin hydrochloride, USP is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The structural formula is as shown. Glyburide and metformin hydrochloride tablets, USP are available in film coated tablets containing: 1 1.25 mg glyburide, USP and 250 mg metformin hydrochloride, USP (equivalent to 194.97 mg metformin);, 2 2.5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin);, 3 5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin).</Description>
</NDC>
<NDC>
<NDCCode>68382-653-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (68382-653-05) </PackageDescription>
<NDC11Code>68382-0653-05</NDC11Code>
<ProductNDC>68382-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyburide And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Glyburide And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206748</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>GLYBURIDE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.25; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide, USP and metformin hydrochloride, USP. Glyburide, USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide, USP is a white or almost white, crystalline powder with a molecular formula of C23H28ClN3O5S and a molecular weight of 494. The glyburide used in glyburide and metformin hydrochloride tablets, USP has a particle size at least 20% are less than 2 micron, at least 80% are less than 10 micron and 100% are less than 40 micron. The structural formula is represented below. Metformin hydrochloride, USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white crystals with a molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.62. Metformin hydrochloride, USP is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The structural formula is as shown. Glyburide and metformin hydrochloride tablets, USP are available in film coated tablets containing: 1 1.25 mg glyburide, USP and 250 mg metformin hydrochloride, USP (equivalent to 194.97 mg metformin);, 2 2.5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin);, 3 5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin).</Description>
</NDC>
<NDC>
<NDCCode>68382-653-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (68382-653-10) </PackageDescription>
<NDC11Code>68382-0653-10</NDC11Code>
<ProductNDC>68382-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyburide And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Glyburide And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206748</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>GLYBURIDE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.25; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide, USP and metformin hydrochloride, USP. Glyburide, USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide, USP is a white or almost white, crystalline powder with a molecular formula of C23H28ClN3O5S and a molecular weight of 494. The glyburide used in glyburide and metformin hydrochloride tablets, USP has a particle size at least 20% are less than 2 micron, at least 80% are less than 10 micron and 100% are less than 40 micron. The structural formula is represented below. Metformin hydrochloride, USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white crystals with a molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.62. Metformin hydrochloride, USP is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The structural formula is as shown. Glyburide and metformin hydrochloride tablets, USP are available in film coated tablets containing: 1 1.25 mg glyburide, USP and 250 mg metformin hydrochloride, USP (equivalent to 194.97 mg metformin);, 2 2.5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin);, 3 5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin).</Description>
</NDC>
<NDC>
<NDCCode>68382-653-16</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68382-653-16) </PackageDescription>
<NDC11Code>68382-0653-16</NDC11Code>
<ProductNDC>68382-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyburide And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Glyburide And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206748</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>GLYBURIDE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.25; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide, USP and metformin hydrochloride, USP. Glyburide, USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide, USP is a white or almost white, crystalline powder with a molecular formula of C23H28ClN3O5S and a molecular weight of 494. The glyburide used in glyburide and metformin hydrochloride tablets, USP has a particle size at least 20% are less than 2 micron, at least 80% are less than 10 micron and 100% are less than 40 micron. The structural formula is represented below. Metformin hydrochloride, USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white crystals with a molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.62. Metformin hydrochloride, USP is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The structural formula is as shown. Glyburide and metformin hydrochloride tablets, USP are available in film coated tablets containing: 1 1.25 mg glyburide, USP and 250 mg metformin hydrochloride, USP (equivalent to 194.97 mg metformin);, 2 2.5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin);, 3 5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin).</Description>
</NDC>
<NDC>
<NDCCode>68382-653-77</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68382-653-77) / 10 TABLET in 1 BLISTER PACK (68382-653-30) </PackageDescription>
<NDC11Code>68382-0653-77</NDC11Code>
<ProductNDC>68382-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glyburide And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Glyburide And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206748</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>GLYBURIDE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.25; 250</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Glyburide and metformin hydrochloride tablets, USP for oral use contain glyburide, USP and metformin hydrochloride, USP. Glyburide, USP is a sulfonylurea and its chemical name is 1-[[p-[2-(5-chloro-o-anisamido) ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide, USP is a white or almost white, crystalline powder with a molecular formula of C23H28ClN3O5S and a molecular weight of 494. The glyburide used in glyburide and metformin hydrochloride tablets, USP has a particle size at least 20% are less than 2 micron, at least 80% are less than 10 micron and 100% are less than 40 micron. The structural formula is represented below. Metformin hydrochloride, USP is a biguanide in hydrochloride salt form and its chemical name is N,N-dimethylimidodicarbonimidic diamide monohydrochloride. It is a white crystals with a molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.62. Metformin hydrochloride, USP is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The structural formula is as shown. Glyburide and metformin hydrochloride tablets, USP are available in film coated tablets containing: 1 1.25 mg glyburide, USP and 250 mg metformin hydrochloride, USP (equivalent to 194.97 mg metformin);, 2 2.5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin);, 3 5 mg glyburide, USP and 500 mg metformin hydrochloride, USP (equivalent to 389.93 mg metformin).</Description>
</NDC>
<NDC>
<NDCCode>36800-653-06</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (36800-653-06) / 45 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>36800-0653-06</NDC11Code>
<ProductNDC>36800-653</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Relief</ProprietaryName>
<NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211075</ApplicationNumber>
<LabelerName>TOPCO ASSOCIATES LLC</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>Deprecated</Status>
<LastUpdate>2023-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211116</StartMarketingDatePackage>
<EndMarketingDatePackage>20231130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43063-653-06</NDCCode>
<PackageDescription>6 TABLET in 1 BOTTLE, PLASTIC (43063-653-06) </PackageDescription>
<NDC11Code>43063-0653-06</NDC11Code>
<ProductNDC>43063-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone And Acetaminophen</ProprietaryName>
<NonProprietaryName>Oxycodone And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201278</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-11-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64980-653-06</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (64980-653-06) </PackageDescription>
<NDC11Code>64980-0653-06</NDC11Code>
<ProductNDC>64980-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075413</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white to off-white crystalline powder, very soluble in water, freely soluble in methanol, sparingly soluble in acetonitrile and practically insoluble in n-Hexane with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C21H31N5O2 HCl is represented by the following structural formula. Buspirone hydrochloride is supplied as tablets for oral administration contains 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP. The 5 mg, 7.5 mg1 and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10-mg tablet can provide a 5 mg dose. The 15 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two-thirds of a tablet), 7.5 mg (one-half of a tablet) or 5 mg (one-third of a tablet). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a tablet). Buspirone hydrochloride tablets USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. 1Note :- Not applicable for divided doses. FDA approved dissolution test specification differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>68180-653-06</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (68180-653-06) </PackageDescription>
<NDC11Code>68180-0653-06</NDC11Code>
<ProductNDC>68180-653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxyclycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171030</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208818</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68428-653-06</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (68428-653-06) </PackageDescription>
<NDC11Code>68428-0653-06</NDC11Code>
<ProductNDC>68428-653</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Strophanthus Hispidus</ProprietaryName>
<NonProprietaryName>Strophanthus Hispidus Seed</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100826</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>STROPHANTHUS HISPIDUS SEED</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>79939-653-06</NDCCode>
<PackageDescription>20000 mL in 1 BOTTLE (79939-653-06) </PackageDescription>
<NDC11Code>79939-0653-06</NDC11Code>
<ProductNDC>79939-653</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antiseptic Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20201019</StartMarketingDate>
<EndMarketingDate>20211019</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>FUJIMURA TRADING, S.A. DE C.V.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201019</StartMarketingDatePackage>
<EndMarketingDatePackage>20211019</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-001-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68382-001-06) </PackageDescription>
<NDC11Code>68382-0001-06</NDC11Code>
<ProductNDC>68382-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077584</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
<Description>Paroxetine tablets, USP contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride, USP is an odorless, white to off-white crystalline powder, having a melting point range of 120°C to 138°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in dichloromethane and slightly soluble in water. Paroxetine tablets are for oral administration. Each film-coated tablet contains 10 mg, 20 mg, 30 mg, or 40 mg of paroxetine equivalent to 11.1 mg, 22.2 mg, 33.3 mg or 44.4 mg of paroxetine hydrochloride, respectively. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68382-018-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68382-018-06) </PackageDescription>
<NDC11Code>68382-0018-06</NDC11Code>
<ProductNDC>68382-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077653</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder. It is soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Each venlafaxine tablet, USP intended for oral administration contains venlafaxine hydrochloride equivalent to 25 mg or 37.5 mg or 50 mg or 75 mg or 100 mg of venlafaxine. In addition, each tablet contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>68382-019-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68382-019-06) </PackageDescription>
<NDC11Code>68382-0019-06</NDC11Code>
<ProductNDC>68382-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077653</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder. It is soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Each venlafaxine tablet, USP intended for oral administration contains venlafaxine hydrochloride equivalent to 25 mg or 37.5 mg or 50 mg or 75 mg or 100 mg of venlafaxine. In addition, each tablet contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>68382-020-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68382-020-06) </PackageDescription>
<NDC11Code>68382-0020-06</NDC11Code>
<ProductNDC>68382-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077653</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder. It is soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Each venlafaxine tablet, USP intended for oral administration contains venlafaxine hydrochloride equivalent to 25 mg or 37.5 mg or 50 mg or 75 mg or 100 mg of venlafaxine. In addition, each tablet contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>68382-021-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68382-021-06) </PackageDescription>
<NDC11Code>68382-0021-06</NDC11Code>
<ProductNDC>68382-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077653</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder. It is soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Each venlafaxine tablet, USP intended for oral administration contains venlafaxine hydrochloride equivalent to 25 mg or 37.5 mg or 50 mg or 75 mg or 100 mg of venlafaxine. In addition, each tablet contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>68382-034-06</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-034-06) </PackageDescription>
<NDC11Code>68382-0034-06</NDC11Code>
<ProductNDC>68382-034</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090174</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder; soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Venlafaxine hydrochloride extended-release capsules, USP intended for oral administration contains 37.5 mg, 75 mg and 150 mg of venlafaxine. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, cetostearyl alcohol, gelatin, hypromellose, microcrystalline cellulose, polyacrylate dispersion, sodium lauryl sulfate, talc and titanium dioxide. Additionally each 37.5 mg capsule shell contains black iron oxide and each 75 mg and 150 mg capsule shell contains red iron oxide. The capsule is printed with black pharmaceutical ink which contains black iron oxide as coloring agent. The product complies with USP dissolution test 7.</Description>
</NDC>
<NDC>
<NDCCode>68382-035-06</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-035-06) </PackageDescription>
<NDC11Code>68382-0035-06</NDC11Code>
<ProductNDC>68382-035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090174</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder; soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Venlafaxine hydrochloride extended-release capsules, USP intended for oral administration contains 37.5 mg, 75 mg and 150 mg of venlafaxine. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, cetostearyl alcohol, gelatin, hypromellose, microcrystalline cellulose, polyacrylate dispersion, sodium lauryl sulfate, talc and titanium dioxide. Additionally each 37.5 mg capsule shell contains black iron oxide and each 75 mg and 150 mg capsule shell contains red iron oxide. The capsule is printed with black pharmaceutical ink which contains black iron oxide as coloring agent. The product complies with USP dissolution test 7.</Description>
</NDC>
<NDC>
<NDCCode>68382-036-06</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-036-06) </PackageDescription>
<NDC11Code>68382-0036-06</NDC11Code>
<ProductNDC>68382-036</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090174</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder; soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Venlafaxine hydrochloride extended-release capsules, USP intended for oral administration contains 37.5 mg, 75 mg and 150 mg of venlafaxine. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, cetostearyl alcohol, gelatin, hypromellose, microcrystalline cellulose, polyacrylate dispersion, sodium lauryl sulfate, talc and titanium dioxide. Additionally each 37.5 mg capsule shell contains black iron oxide and each 75 mg and 150 mg capsule shell contains red iron oxide. The capsule is printed with black pharmaceutical ink which contains black iron oxide as coloring agent. The product complies with USP dissolution test 7.</Description>
</NDC>
<NDC>
<NDCCode>68382-043-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68382-043-06) </PackageDescription>
<NDC11Code>68382-0043-06</NDC11Code>
<ProductNDC>68382-043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077106</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-044-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68382-044-06) </PackageDescription>
<NDC11Code>68382-0044-06</NDC11Code>
<ProductNDC>68382-044</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077106</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-045-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68382-045-06) </PackageDescription>
<NDC11Code>68382-0045-06</NDC11Code>
<ProductNDC>68382-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077106</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals (USA) Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68382-065-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68382-065-06) </PackageDescription>
<NDC11Code>68382-0065-06</NDC11Code>
<ProductNDC>68382-065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077837</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin is indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):, 3 In adults with primary hyperlipidemia., 4 In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH)., 6 As an adjunct to diet for the treatment of adults with:, 7 Primary dysbetalipoproteinemia., 8 Hypertriglyceridemia.</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white powder that is practically insoluble in water; freely soluble in chloroform, in methanol and in alcohol; sparingly soluble in propylene glycol; very slightly soluble in hexane. Each simvastatin tablet intended for oral administration contains 5 mg or 10 mg or 20 mg or 40 mg or 80 mg of simvastatin. In addition, each tablet contains following inactive ingredients: ascorbic acid, citric acid anhydrous, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, pregelatinized starch, talc and titanium dioxide. Additionally, each 10 mg tablet contains iron oxide red and iron oxide yellow, 20 mg tablet contains iron oxide black, iron oxide red and iron oxide yellow and 40 mg tablet contains iron oxide red. Butylated hydroxyanisole is added as a preservative. The botanical source for Pregelatinized starch is corn starch.</Description>
</NDC>
<NDC>
<NDCCode>68382-066-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68382-066-06) </PackageDescription>
<NDC11Code>68382-0066-06</NDC11Code>
<ProductNDC>68382-066</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077837</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin is indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):, 3 In adults with primary hyperlipidemia., 4 In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH)., 6 As an adjunct to diet for the treatment of adults with:, 7 Primary dysbetalipoproteinemia., 8 Hypertriglyceridemia.</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white powder that is practically insoluble in water; freely soluble in chloroform, in methanol and in alcohol; sparingly soluble in propylene glycol; very slightly soluble in hexane. Each simvastatin tablet intended for oral administration contains 5 mg or 10 mg or 20 mg or 40 mg or 80 mg of simvastatin. In addition, each tablet contains following inactive ingredients: ascorbic acid, citric acid anhydrous, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, pregelatinized starch, talc and titanium dioxide. Additionally, each 10 mg tablet contains iron oxide red and iron oxide yellow, 20 mg tablet contains iron oxide black, iron oxide red and iron oxide yellow and 40 mg tablet contains iron oxide red. Butylated hydroxyanisole is added as a preservative. The botanical source for Pregelatinized starch is corn starch.</Description>
</NDC>
<NDC>
<NDCCode>68382-067-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68382-067-06) </PackageDescription>
<NDC11Code>68382-0067-06</NDC11Code>
<ProductNDC>68382-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077837</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin is indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):, 3 In adults with primary hyperlipidemia., 4 In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH)., 6 As an adjunct to diet for the treatment of adults with:, 7 Primary dysbetalipoproteinemia., 8 Hypertriglyceridemia.</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white powder that is practically insoluble in water; freely soluble in chloroform, in methanol and in alcohol; sparingly soluble in propylene glycol; very slightly soluble in hexane. Each simvastatin tablet intended for oral administration contains 5 mg or 10 mg or 20 mg or 40 mg or 80 mg of simvastatin. In addition, each tablet contains following inactive ingredients: ascorbic acid, citric acid anhydrous, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, pregelatinized starch, talc and titanium dioxide. Additionally, each 10 mg tablet contains iron oxide red and iron oxide yellow, 20 mg tablet contains iron oxide black, iron oxide red and iron oxide yellow and 40 mg tablet contains iron oxide red. Butylated hydroxyanisole is added as a preservative. The botanical source for Pregelatinized starch is corn starch.</Description>
</NDC>
<NDC>
<NDCCode>68382-068-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68382-068-06) </PackageDescription>
<NDC11Code>68382-0068-06</NDC11Code>
<ProductNDC>68382-068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077837</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin is indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):, 3 In adults with primary hyperlipidemia., 4 In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH)., 6 As an adjunct to diet for the treatment of adults with:, 7 Primary dysbetalipoproteinemia., 8 Hypertriglyceridemia.</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white powder that is practically insoluble in water; freely soluble in chloroform, in methanol and in alcohol; sparingly soluble in propylene glycol; very slightly soluble in hexane. Each simvastatin tablet intended for oral administration contains 5 mg or 10 mg or 20 mg or 40 mg or 80 mg of simvastatin. In addition, each tablet contains following inactive ingredients: ascorbic acid, citric acid anhydrous, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, pregelatinized starch, talc and titanium dioxide. Additionally, each 10 mg tablet contains iron oxide red and iron oxide yellow, 20 mg tablet contains iron oxide black, iron oxide red and iron oxide yellow and 40 mg tablet contains iron oxide red. Butylated hydroxyanisole is added as a preservative. The botanical source for Pregelatinized starch is corn starch.</Description>
</NDC>
<NDC>
<NDCCode>68382-069-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68382-069-06) </PackageDescription>
<NDC11Code>68382-0069-06</NDC11Code>
<ProductNDC>68382-069</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077837</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin is indicated: 1 To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):, 3 In adults with primary hyperlipidemia., 4 In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH)., 6 As an adjunct to diet for the treatment of adults with:, 7 Primary dysbetalipoproteinemia., 8 Hypertriglyceridemia.</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white powder that is practically insoluble in water; freely soluble in chloroform, in methanol and in alcohol; sparingly soluble in propylene glycol; very slightly soluble in hexane. Each simvastatin tablet intended for oral administration contains 5 mg or 10 mg or 20 mg or 40 mg or 80 mg of simvastatin. In addition, each tablet contains following inactive ingredients: ascorbic acid, citric acid anhydrous, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, pregelatinized starch, talc and titanium dioxide. Additionally, each 10 mg tablet contains iron oxide red and iron oxide yellow, 20 mg tablet contains iron oxide black, iron oxide red and iron oxide yellow and 40 mg tablet contains iron oxide red. Butylated hydroxyanisole is added as a preservative. The botanical source for Pregelatinized starch is corn starch.</Description>
</NDC>
<NDC>
<NDCCode>68382-074-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (68382-074-06) </PackageDescription>
<NDC11Code>68382-0074-06</NDC11Code>
<ProductNDC>68382-074</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finasteride</ProprietaryName>
<NonProprietaryName>Finasteride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078900</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FINASTERIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Finasteride tablets, are 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1): 1 Improve symptoms , 2 Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. .</IndicationAndUsage>
<Description>Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-,(5α,17β)-. The molecular formula of finasteride is C23H36N2O2 and its molecular weight is 372.55. Its structural formula is:. Finasteride, USP is a white to off-white, crystalline solid which melts between 251(C and 258(C. It is freely soluble in chloroform and in alcohol. Each finasteride tablet intended for oral administration contains 5 mg of finasteride. In addition, each tablet contains the following inactive ingredients: docusate sodium, FD&C blue # 2, hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc and titanium dioxide. The tablet is printed with black pharmaceutical ink which contains following major ingredients: Shellac Glaze and black iron oxide. The starch source for sodium starch glycolate is potato starch and for Pregelatinized starch is corn starch.</Description>
</NDC>
<NDC>
<NDCCode>68382-080-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68382-080-06) </PackageDescription>
<NDC11Code>68382-0080-06</NDC11Code>
<ProductNDC>68382-080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077580</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol is indicated for use in the management of manifestations of psychotic disorders. Haloperidol is indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol is effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol is also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
<Description>Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone. It has the following structural formula. Each haloperidol tablet, USP intended for oral administration contains haloperidol, USP 0.5 mg or 1 mg or 2 mg or 5 mg or 10 mg or 20 mg. In addition each 0.5 mg, 1 mg, 2 mg tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize) and each 5 mg, 10 mg, 20 mg tablet contains the following inactive ingredients: calcium stearate, dibasic calcium phosphate dihydrate, povidone (PVP K 30), sodium starch glycolate and starch. 1 mg: D&C Yellow #10 Aluminium Lake, FD&C Yellow #6 Aluminium Lake; 2 mg: D & C Red #27 Aluminum Lake; 5 mg: D & C Yellow #10 Aluminum Lake and FD & C Blue #1 Aluminum Lake; 10 mg: D & C Yellow #10 Aluminum Lake and FD & C Blue #1 Aluminum Lake; 20 mg: FD & C Yellow #6 Aluminum Lake and D & C Red #27 Aluminum Lake.</Description>
</NDC>
</NDCList>