{
"NDC": [
{
"NDCCode": "84386-153-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (84386-153-30) ",
"NDC11Code": "84386-0153-30",
"ProductNDC": "84386-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alfuzosin Hydrochloride",
"NonProprietaryName": "Alfuzosin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079060",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ALFUZOSIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.",
"Description": "Each alfuzosin hydrochloride extended-release tablet USP contains 10 mg alfuzosin hydrochloride USP as the active ingredient. Alfuzosin hydrochloride USP is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The molecular formula of alfuzosin hydrochloride is C19H27N5O4HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is. The tablet also contains the following inactive ingredients: carbomer homopolymer type B, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, magnesium stearate, povidone, propylene glycol, and titanium dioxide. Meets USP Dissolution Test 5."
},
{
"NDCCode": "84386-153-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (84386-153-01) ",
"NDC11Code": "84386-0153-01",
"ProductNDC": "84386-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alfuzosin Hydrochloride",
"NonProprietaryName": "Alfuzosin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079060",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ALFUZOSIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.",
"Description": "Each alfuzosin hydrochloride extended-release tablet USP contains 10 mg alfuzosin hydrochloride USP as the active ingredient. Alfuzosin hydrochloride USP is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The molecular formula of alfuzosin hydrochloride is C19H27N5O4HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is. The tablet also contains the following inactive ingredients: carbomer homopolymer type B, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, magnesium stearate, povidone, propylene glycol, and titanium dioxide. Meets USP Dissolution Test 5."
},
{
"NDCCode": "84386-153-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (84386-153-05) ",
"NDC11Code": "84386-0153-05",
"ProductNDC": "84386-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alfuzosin Hydrochloride",
"NonProprietaryName": "Alfuzosin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079060",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ALFUZOSIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.",
"Description": "Each alfuzosin hydrochloride extended-release tablet USP contains 10 mg alfuzosin hydrochloride USP as the active ingredient. Alfuzosin hydrochloride USP is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The molecular formula of alfuzosin hydrochloride is C19H27N5O4HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is. The tablet also contains the following inactive ingredients: carbomer homopolymer type B, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, magnesium stearate, povidone, propylene glycol, and titanium dioxide. Meets USP Dissolution Test 5."
},
{
"NDCCode": "84386-153-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (84386-153-90) ",
"NDC11Code": "84386-0153-90",
"ProductNDC": "84386-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alfuzosin Hydrochloride",
"NonProprietaryName": "Alfuzosin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079060",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ALFUZOSIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.",
"Description": "Each alfuzosin hydrochloride extended-release tablet USP contains 10 mg alfuzosin hydrochloride USP as the active ingredient. Alfuzosin hydrochloride USP is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The molecular formula of alfuzosin hydrochloride is C19H27N5O4HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is. The tablet also contains the following inactive ingredients: carbomer homopolymer type B, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, magnesium stearate, povidone, propylene glycol, and titanium dioxide. Meets USP Dissolution Test 5."
},
{
"NDCCode": "84386-153-99",
"PackageDescription": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (84386-153-99) ",
"NDC11Code": "84386-0153-99",
"ProductNDC": "84386-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alfuzosin Hydrochloride",
"NonProprietaryName": "Alfuzosin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079060",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ALFUZOSIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.",
"Description": "Each alfuzosin hydrochloride extended-release tablet USP contains 10 mg alfuzosin hydrochloride USP as the active ingredient. Alfuzosin hydrochloride USP is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The molecular formula of alfuzosin hydrochloride is C19H27N5O4HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is. The tablet also contains the following inactive ingredients: carbomer homopolymer type B, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, magnesium stearate, povidone, propylene glycol, and titanium dioxide. Meets USP Dissolution Test 5."
},
{
"NDCCode": "84386-084-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (84386-084-30) ",
"NDC11Code": "84386-0084-30",
"ProductNDC": "84386-084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20261002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220492",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261002",
"SamplePackage": "N",
"IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .",
"Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg)."
},
{
"NDCCode": "84386-085-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (84386-085-30) ",
"NDC11Code": "84386-0085-30",
"ProductNDC": "84386-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20261002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220492",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261002",
"SamplePackage": "N",
"IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .",
"Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg)."
},
{
"NDCCode": "84386-086-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (84386-086-30) ",
"NDC11Code": "84386-0086-30",
"ProductNDC": "84386-086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20261002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220492",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261002",
"SamplePackage": "N",
"IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .",
"Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg)."
},
{
"NDCCode": "84386-087-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (84386-087-30) ",
"NDC11Code": "84386-0087-30",
"ProductNDC": "84386-087",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20261002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220492",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261002",
"SamplePackage": "N",
"IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .",
"Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg)."
},
{
"NDCCode": "84386-088-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (84386-088-30) ",
"NDC11Code": "84386-0088-30",
"ProductNDC": "84386-088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20261002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220492",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261002",
"SamplePackage": "N",
"IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .",
"Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg)."
},
{
"NDCCode": "84386-089-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (84386-089-30) ",
"NDC11Code": "84386-0089-30",
"ProductNDC": "84386-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20261002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220492",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "12",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261002",
"SamplePackage": "N",
"IndicationAndUsage": "Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .",
"Description": "Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg)."
},
{
"NDCCode": "84386-097-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (84386-097-30) ",
"NDC11Code": "84386-0097-30",
"ProductNDC": "84386-097",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077206",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251120",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)].",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white to off-white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propyl gallate, sodium starch glycolate and titanium dioxide. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
},
{
"NDCCode": "84386-098-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (84386-098-30) ",
"NDC11Code": "84386-0098-30",
"ProductNDC": "84386-098",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077206",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251120",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)].",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white to off-white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propyl gallate, sodium starch glycolate and titanium dioxide. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
},
{
"NDCCode": "84386-099-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (84386-099-30) ",
"NDC11Code": "84386-0099-30",
"ProductNDC": "84386-099",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077206",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251120",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)].",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white to off-white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propyl gallate, sodium starch glycolate and titanium dioxide. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
},
{
"NDCCode": "84386-104-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (84386-104-30) ",
"NDC11Code": "84386-0104-30",
"ProductNDC": "84386-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213286",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260115",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine is a selective serotonin reuptake inhibitor indicated for.",
"Description": "Fluoxetine is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy] propylamine hydrochloride and has the molecular formula of C17H18F3NO·HCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Each tablet contains fluoxetine hydrochloride USP equivalent to 10 mg (32.3 μmol) or 20 mg (64.7 μmol) of fluoxetine. In addition, each tablet also contains the following inactive ingredients: corn starch, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide."
},
{
"NDCCode": "84386-105-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (84386-105-30) ",
"NDC11Code": "84386-0105-30",
"ProductNDC": "84386-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213286",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260115",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine is a selective serotonin reuptake inhibitor indicated for.",
"Description": "Fluoxetine is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy] propylamine hydrochloride and has the molecular formula of C17H18F3NO·HCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Each tablet contains fluoxetine hydrochloride USP equivalent to 10 mg (32.3 μmol) or 20 mg (64.7 μmol) of fluoxetine. In addition, each tablet also contains the following inactive ingredients: corn starch, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide."
},
{
"NDCCode": "84386-106-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (84386-106-30) ",
"NDC11Code": "84386-0106-30",
"ProductNDC": "84386-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213265",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260115",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine tablets are indicated for the treatment of.",
"Description": "Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Each scored tablet contains fluoxetine hydrochloride USP equivalent to 60 mg (194 µmol) of fluoxetine. In addition, each scored tablet also contains the following inactive ingredients: corn starch, glycerin, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, sucrose and titanium dioxide."
},
{
"NDCCode": "84386-111-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (84386-111-30) ",
"NDC11Code": "84386-0111-30",
"ProductNDC": "84386-111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206125",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260323",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).",
"Description": "Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The molecular formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula: Cinacalcet tablets are formulated as light green, film-coated, oval shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: ascorbic acid, colloidal silicon dioxide, crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), sodium stearyl fumarate, titanium dioxide and triacetin."
},
{
"NDCCode": "84386-112-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (84386-112-30) ",
"NDC11Code": "84386-0112-30",
"ProductNDC": "84386-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206125",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260323",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).",
"Description": "Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The molecular formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula: Cinacalcet tablets are formulated as light green, film-coated, oval shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: ascorbic acid, colloidal silicon dioxide, crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), sodium stearyl fumarate, titanium dioxide and triacetin."
},
{
"NDCCode": "84386-113-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (84386-113-30) ",
"NDC11Code": "84386-0113-30",
"ProductNDC": "84386-113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206125",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260323",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).",
"Description": "Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The molecular formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula: Cinacalcet tablets are formulated as light green, film-coated, oval shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: ascorbic acid, colloidal silicon dioxide, crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), sodium stearyl fumarate, titanium dioxide and triacetin."
},
{
"NDCCode": "10544-153-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (10544-153-30)",
"NDC11Code": "10544-0153-30",
"ProductNDC": "10544-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065061",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin hydrochloride capsules, USP are the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. C18H33ClN2O5SHCl M.W. 461.45. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride."
},
{
"NDCCode": "12258-153-01",
"PackageDescription": "30 mL in 1 BOTTLE (12258-153-01) ",
"NDC11Code": "12258-0153-01",
"ProductNDC": "12258-153",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dri-ear",
"NonProprietaryName": "Dri-ear",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20240430",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M014",
"LabelerName": "S.S.S. Company",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "950",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "Dries water in the ears and relieves water clogged ears."
},
{
"NDCCode": "13310-153-07",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (13310-153-07)",
"NDC11Code": "13310-0153-07",
"ProductNDC": "13310-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Qualaquin",
"NonProprietaryName": "Quinine Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20050812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021799",
"LabelerName": "AR Scientific Inc.",
"SubstanceName": "QUININE SULFATE",
"StrengthNumber": "324",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "QUALAQUIN (quinine sulfate) is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. QUALAQUIN oral capsules are not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].",
"Description": "QUALAQUIN (quinine sulfate) is a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2H2SO42H2O and a molecular weight of 782.96. The structural formula of quinine sulfate is. Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. QUALAQUIN is supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc."
},
{
"NDCCode": "13668-153-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (13668-153-30) ",
"NDC11Code": "13668-0153-30",
"ProductNDC": "13668-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine Fumarate",
"NonProprietaryName": "Quetiapine Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200363",
"LabelerName": "TORRENT PHARMACEUTICALS LIMITED",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-03-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120327",
"SamplePackage": "N"
},
{
"NDCCode": "16590-153-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16590-153-30)",
"NDC11Code": "16590-0153-30",
"ProductNDC": "16590-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076312",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Mirtazapine Tablets USP are indicated for the treatment of major depressive disorder. The efficacy of mirtazapine in the treatment of major depressive disorder was established in six week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders-3rd edition (DSM-lll) category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-lV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The effectiveness of mirtazapine in hospitalized depressed patients has not been adequately studied. The efficacy of mirtazapine in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8-12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (See CLINICAL PHARMACOLOGY).",
"Description": "Mirtazapine Tablets USP are an orally administered drug. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]benzazepine and has the molecular formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine is supplied for oral administration as scored, film-coated tablets containing 15 mg, 30 mg or 45 mg mirtazapine. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, opadry white (for 15 mg and 45 mg tablets only, hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide) and opadry yellow (for 30 mg only, hypromellose, iron oxide yellow, polyethylene glycol, polysorbate 80, and titanium dioxide)."
},
{
"NDCCode": "16714-153-01",
"PackageDescription": "30 TABLET in 1 BOTTLE (16714-153-01) ",
"NDC11Code": "16714-0153-01",
"ProductNDC": "16714-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiagabine Hydrochloride",
"NonProprietaryName": "Tiagabine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214816",
"LabelerName": "Northstar Rx LLC",
"SubstanceName": "TIAGABINE HYDROCHLORIDE",
"StrengthNumber": "12",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20211124",
"SamplePackage": "N",
"IndicationAndUsage": "Tiagabine hydrochloride tablet is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.",
"Description": "Tiagabine hydrochloride USP is an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3 butenyl]nipecotic acid hydrochloride, its molecular formula is C20H25NO2S2 HCl, and its molecular weight is 412.01. Tiagabine HCl, USP is a white to off-white powder. It is freely soluble in methanol and in alcohol, soluble in 5% Water in isopropanol, very slightly soluble in chloroform, sparingly soluble in water and practically insoluble in n-Heptane. The structural formula is. Inactive Ingredients Tiagabine hydrochloride tablets contain the following inactive ingredients: Butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil (cottonseed oil), hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, stearic acid and titanium dioxide. In addition, individual tablets contain: 2 mg tablets: FD&C yellow No. 6 aluminum lake 4 mg tablets: D&C yellow No. 10 aluminum lake 12 mg tablets: D&C yellow No. 10 aluminum lake and FD&C Blue No. 1 aluminum lake 16 mg tablets: FD&C blue No. 2 aluminum lake."
},
{
"NDCCode": "21749-153-01",
"PackageDescription": "30 mL in 1 BOTTLE (21749-153-01) ",
"NDC11Code": "21749-0153-01",
"ProductNDC": "21749-153",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Purell Advanced Hand Sanitizer Holiday Spice",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121101",
"EndMarketingDate": "20190731",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "GOJO Industries, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20121101",
"EndMarketingDatePackage": "20190731",
"SamplePackage": "N"
},
{
"NDCCode": "22700-153-30",
"PackageDescription": "30 mL in 1 BOTTLE, PUMP (22700-153-30) ",
"NDC11Code": "22700-0153-30",
"ProductNDC": "22700-153",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Covergirl Queen Collection All Day Flawless 3in1 Foundation",
"ProprietaryNameSuffix": "Broad Spectrum Spf 20 - Q860 Rich Mink",
"NonProprietaryName": "Ensulizole",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120901",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Noxell",
"SubstanceName": "ENSULIZOLE",
"StrengthNumber": ".03",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120901",
"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "23594-153-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-153-30) ",
"NDC11Code": "23594-0153-30",
"ProductNDC": "23594-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Exxua",
"NonProprietaryName": "Gepirone",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021164",
"LabelerName": "Aytu Therapeutics, LLC",
"SubstanceName": "GEPIRONE HYDROCHLORIDE",
"StrengthNumber": "72.6",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251001",
"SamplePackage": "N",
"IndicationAndUsage": "EXXUA is indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "EXXUA contains gepirone, in the salt form as gepirone hydrochloride (HCl). The chemical name is 2,6- piperidinedione,4,4-dimethyl-1-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-, monohydrochloride. The molecular weight of gepirone HCl is 395.93 and the structural formula is as follows. Gepirone HCl is a white to off-white crystalline powder, which is readily soluble in water. EXXUA is supplied as extended-release tablets for oral administration. Each extended-release tablet contains 18.2 mg, 36.3 mg, 54.5 mg, or 72.6 mg, gepirone equivalent to 20 mg, 40 mg, 60 mg, or 80 mg of gepirone HCl respectively. The extended-release tablets also contain the following inactive ingredients: colloidal silicon dioxide, Hypromellose, iron oxide (red and/or yellow colorants), magnesium stearate, and microcrystalline cellulose."
},
{
"NDCCode": "31722-153-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (31722-153-30) ",
"NDC11Code": "31722-0153-30",
"ProductNDC": "31722-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203311",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210623",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1) Heart failure(NYHA class II to IV), to reduce hospitalization for heart failure in adults ( 1.2) Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults ( 1.3).",
"Description": "Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1receptor subtype. Valsartan is chemically described as L-valine, N-(1-oxopentyl)- N-[[2′-(1 H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-. Its molecular formula is C 24H 29N 5O 3, its molecular weight is 435.52, and its structural formula is. Valsartan, USP is a white to an off-white powder. It is soluble in ethanol and methanol and insoluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan USP. The inactive ingredients of the tablets are croscarmellose sodium, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, and titanium dioxide. In addition to this 40 mg contains iron oxide yellow, 80 mg contains iron oxide red, 160 mg contains iron oxides (yellow and red) and 320 mg contains iron oxides (yellow, red and black). Meets USP dissolution test 2."
}
]
}
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<NDCList>
<NDC>
<NDCCode>84386-153-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (84386-153-30) </PackageDescription>
<NDC11Code>84386-0153-30</NDC11Code>
<ProductNDC>84386-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alfuzosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Alfuzosin Hydrochloride</NonProprietaryName>
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<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.</IndicationAndUsage>
<Description>Each alfuzosin hydrochloride extended-release tablet USP contains 10 mg alfuzosin hydrochloride USP as the active ingredient. Alfuzosin hydrochloride USP is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The molecular formula of alfuzosin hydrochloride is C19H27N5O4HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is. The tablet also contains the following inactive ingredients: carbomer homopolymer type B, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, magnesium stearate, povidone, propylene glycol, and titanium dioxide. Meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>84386-153-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (84386-153-01) </PackageDescription>
<NDC11Code>84386-0153-01</NDC11Code>
<ProductNDC>84386-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alfuzosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Alfuzosin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.</IndicationAndUsage>
<Description>Each alfuzosin hydrochloride extended-release tablet USP contains 10 mg alfuzosin hydrochloride USP as the active ingredient. Alfuzosin hydrochloride USP is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The molecular formula of alfuzosin hydrochloride is C19H27N5O4HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is. The tablet also contains the following inactive ingredients: carbomer homopolymer type B, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, magnesium stearate, povidone, propylene glycol, and titanium dioxide. Meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>84386-153-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (84386-153-05) </PackageDescription>
<NDC11Code>84386-0153-05</NDC11Code>
<ProductNDC>84386-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alfuzosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Alfuzosin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079060</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ALFUZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.</IndicationAndUsage>
<Description>Each alfuzosin hydrochloride extended-release tablet USP contains 10 mg alfuzosin hydrochloride USP as the active ingredient. Alfuzosin hydrochloride USP is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The molecular formula of alfuzosin hydrochloride is C19H27N5O4HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is. The tablet also contains the following inactive ingredients: carbomer homopolymer type B, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, magnesium stearate, povidone, propylene glycol, and titanium dioxide. Meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>84386-153-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (84386-153-90) </PackageDescription>
<NDC11Code>84386-0153-90</NDC11Code>
<ProductNDC>84386-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alfuzosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Alfuzosin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079060</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ALFUZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.</IndicationAndUsage>
<Description>Each alfuzosin hydrochloride extended-release tablet USP contains 10 mg alfuzosin hydrochloride USP as the active ingredient. Alfuzosin hydrochloride USP is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The molecular formula of alfuzosin hydrochloride is C19H27N5O4HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is. The tablet also contains the following inactive ingredients: carbomer homopolymer type B, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, magnesium stearate, povidone, propylene glycol, and titanium dioxide. Meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>84386-153-99</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (84386-153-99) </PackageDescription>
<NDC11Code>84386-0153-99</NDC11Code>
<ProductNDC>84386-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alfuzosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Alfuzosin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079060</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ALFUZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.</IndicationAndUsage>
<Description>Each alfuzosin hydrochloride extended-release tablet USP contains 10 mg alfuzosin hydrochloride USP as the active ingredient. Alfuzosin hydrochloride USP is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The molecular formula of alfuzosin hydrochloride is C19H27N5O4HCl. The molecular weight of alfuzosin hydrochloride is 425.9. Its structural formula is. The tablet also contains the following inactive ingredients: carbomer homopolymer type B, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, magnesium stearate, povidone, propylene glycol, and titanium dioxide. Meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>84386-084-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (84386-084-30) </PackageDescription>
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<ProductNDC>84386-084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perampanel</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20261002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220492</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PERAMPANEL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .</IndicationAndUsage>
<Description>Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg).</Description>
</NDC>
<NDC>
<NDCCode>84386-085-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (84386-085-30) </PackageDescription>
<NDC11Code>84386-0085-30</NDC11Code>
<ProductNDC>84386-085</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perampanel</ProprietaryName>
<NonProprietaryName>Perampanel</NonProprietaryName>
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<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PERAMPANEL</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .</IndicationAndUsage>
<Description>Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg).</Description>
</NDC>
<NDC>
<NDCCode>84386-086-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (84386-086-30) </PackageDescription>
<NDC11Code>84386-0086-30</NDC11Code>
<ProductNDC>84386-086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perampanel</ProprietaryName>
<NonProprietaryName>Perampanel</NonProprietaryName>
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<StartMarketingDate>20261002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220492</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PERAMPANEL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .</IndicationAndUsage>
<Description>Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg).</Description>
</NDC>
<NDC>
<NDCCode>84386-087-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (84386-087-30) </PackageDescription>
<NDC11Code>84386-0087-30</NDC11Code>
<ProductNDC>84386-087</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perampanel</ProprietaryName>
<NonProprietaryName>Perampanel</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220492</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PERAMPANEL</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .</IndicationAndUsage>
<Description>Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg).</Description>
</NDC>
<NDC>
<NDCCode>84386-088-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (84386-088-30) </PackageDescription>
<NDC11Code>84386-0088-30</NDC11Code>
<ProductNDC>84386-088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perampanel</ProprietaryName>
<NonProprietaryName>Perampanel</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220492</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PERAMPANEL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .</IndicationAndUsage>
<Description>Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg).</Description>
</NDC>
<NDC>
<NDCCode>84386-089-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (84386-089-30) </PackageDescription>
<NDC11Code>84386-0089-30</NDC11Code>
<ProductNDC>84386-089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perampanel</ProprietaryName>
<NonProprietaryName>Perampanel</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20261002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220492</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PERAMPANEL</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1) .</IndicationAndUsage>
<Description>Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is sparingly soluble in dimethylsulfoxide, slightly soluble in ethyl acetate and practically insoluble in water. The chemical structure is. Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide. Tablets of different strengths may contain black iron oxide (8 mg), FD&C Blue No. 2 aluminum lake (10 mg and 12 mg), red iron oxide (2 mg, 4 mg, 6 mg and 8 mg) and yellow iron oxide (2 mg and 10 mg).</Description>
</NDC>
<NDC>
<NDCCode>84386-097-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (84386-097-30) </PackageDescription>
<NDC11Code>84386-0097-30</NDC11Code>
<ProductNDC>84386-097</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077206</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)].</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white to off-white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propyl gallate, sodium starch glycolate and titanium dioxide. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>84386-098-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (84386-098-30) </PackageDescription>
<NDC11Code>84386-0098-30</NDC11Code>
<ProductNDC>84386-098</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077206</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)].</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white to off-white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propyl gallate, sodium starch glycolate and titanium dioxide. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>84386-099-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (84386-099-30) </PackageDescription>
<NDC11Code>84386-0099-30</NDC11Code>
<ProductNDC>84386-099</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077206</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)].</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white to off-white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propyl gallate, sodium starch glycolate and titanium dioxide. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>84386-104-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (84386-104-30) </PackageDescription>
<NDC11Code>84386-0104-30</NDC11Code>
<ProductNDC>84386-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213286</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine is a selective serotonin reuptake inhibitor indicated for.</IndicationAndUsage>
<Description>Fluoxetine is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy] propylamine hydrochloride and has the molecular formula of C17H18F3NO·HCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Each tablet contains fluoxetine hydrochloride USP equivalent to 10 mg (32.3 μmol) or 20 mg (64.7 μmol) of fluoxetine. In addition, each tablet also contains the following inactive ingredients: corn starch, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>84386-105-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (84386-105-30) </PackageDescription>
<NDC11Code>84386-0105-30</NDC11Code>
<ProductNDC>84386-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213286</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine is a selective serotonin reuptake inhibitor indicated for.</IndicationAndUsage>
<Description>Fluoxetine is a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy] propylamine hydrochloride and has the molecular formula of C17H18F3NO·HCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Each tablet contains fluoxetine hydrochloride USP equivalent to 10 mg (32.3 μmol) or 20 mg (64.7 μmol) of fluoxetine. In addition, each tablet also contains the following inactive ingredients: corn starch, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>84386-106-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (84386-106-30) </PackageDescription>
<NDC11Code>84386-0106-30</NDC11Code>
<ProductNDC>84386-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213265</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine tablets are indicated for the treatment of.</IndicationAndUsage>
<Description>Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is. Fluoxetine hydrochloride is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Each scored tablet contains fluoxetine hydrochloride USP equivalent to 60 mg (194 µmol) of fluoxetine. In addition, each scored tablet also contains the following inactive ingredients: corn starch, glycerin, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, sucrose and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>84386-111-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (84386-111-30) </PackageDescription>
<NDC11Code>84386-0111-30</NDC11Code>
<ProductNDC>84386-111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206125</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).</IndicationAndUsage>
<Description>Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The molecular formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula: Cinacalcet tablets are formulated as light green, film-coated, oval shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: ascorbic acid, colloidal silicon dioxide, crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), sodium stearyl fumarate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>84386-112-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (84386-112-30) </PackageDescription>
<NDC11Code>84386-0112-30</NDC11Code>
<ProductNDC>84386-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206125</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).</IndicationAndUsage>
<Description>Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The molecular formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula: Cinacalcet tablets are formulated as light green, film-coated, oval shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: ascorbic acid, colloidal silicon dioxide, crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), sodium stearyl fumarate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>84386-113-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (84386-113-30) </PackageDescription>
<NDC11Code>84386-0113-30</NDC11Code>
<ProductNDC>84386-113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206125</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).</IndicationAndUsage>
<Description>Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The molecular formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula: Cinacalcet tablets are formulated as light green, film-coated, oval shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: ascorbic acid, colloidal silicon dioxide, crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), sodium stearyl fumarate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>10544-153-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (10544-153-30)</PackageDescription>
<NDC11Code>10544-0153-30</NDC11Code>
<ProductNDC>10544-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065061</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin hydrochloride capsules, USP are the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride, USP equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg - black iron oxide, corn starch, D&C Yellow #10, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide; 300 mg - black iron oxide, corn starch, FD&C Blue no. 1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, propylene glycol, shellac, talc, and titanium dioxide. The structural formula is represented below. C18H33ClN2O5SHCl M.W. 461.45. The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6, 7, 8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside monohydrochloride.</Description>
</NDC>
<NDC>
<NDCCode>12258-153-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (12258-153-01) </PackageDescription>
<NDC11Code>12258-0153-01</NDC11Code>
<ProductNDC>12258-153</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dri-ear</ProprietaryName>
<NonProprietaryName>Dri-ear</NonProprietaryName>
<DosageFormName>SUSPENSION/ DROPS</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20240430</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M014</ApplicationNumber>
<LabelerName>S.S.S. Company</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>950</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dries water in the ears and relieves water clogged ears.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13310-153-07</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (13310-153-07)</PackageDescription>
<NDC11Code>13310-0153-07</NDC11Code>
<ProductNDC>13310-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Qualaquin</ProprietaryName>
<NonProprietaryName>Quinine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021799</ApplicationNumber>
<LabelerName>AR Scientific Inc.</LabelerName>
<SubstanceName>QUININE SULFATE</SubstanceName>
<StrengthNumber>324</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>QUALAQUIN (quinine sulfate) is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. QUALAQUIN oral capsules are not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>QUALAQUIN (quinine sulfate) is a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C20H24N2O2)2H2SO42H2O and a molecular weight of 782.96. The structural formula of quinine sulfate is. Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. QUALAQUIN is supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate USP, equivalent to 269 mg free base. Inactive ingredients: corn starch, magnesium stearate, and talc.</Description>
</NDC>
<NDC>
<NDCCode>13668-153-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (13668-153-30) </PackageDescription>
<NDC11Code>13668-0153-30</NDC11Code>
<ProductNDC>13668-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine Fumarate</ProprietaryName>
<NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200363</ApplicationNumber>
<LabelerName>TORRENT PHARMACEUTICALS LIMITED</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-03-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16590-153-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16590-153-30)</PackageDescription>
<NDC11Code>16590-0153-30</NDC11Code>
<ProductNDC>16590-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076312</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Mirtazapine Tablets USP are indicated for the treatment of major depressive disorder. The efficacy of mirtazapine in the treatment of major depressive disorder was established in six week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders-3rd edition (DSM-lll) category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-lV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The effectiveness of mirtazapine in hospitalized depressed patients has not been adequately studied. The efficacy of mirtazapine in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8-12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (See CLINICAL PHARMACOLOGY).</IndicationAndUsage>
<Description>Mirtazapine Tablets USP are an orally administered drug. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]benzazepine and has the molecular formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder which is slightly soluble in water. Mirtazapine is supplied for oral administration as scored, film-coated tablets containing 15 mg, 30 mg or 45 mg mirtazapine. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, opadry white (for 15 mg and 45 mg tablets only, hypromellose, polyethylene glycol, polysorbate 80, and titanium dioxide) and opadry yellow (for 30 mg only, hypromellose, iron oxide yellow, polyethylene glycol, polysorbate 80, and titanium dioxide).</Description>
</NDC>
<NDC>
<NDCCode>16714-153-01</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (16714-153-01) </PackageDescription>
<NDC11Code>16714-0153-01</NDC11Code>
<ProductNDC>16714-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiagabine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tiagabine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211124</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214816</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<SubstanceName>TIAGABINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tiagabine hydrochloride tablet is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.</IndicationAndUsage>
<Description>Tiagabine hydrochloride USP is an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3 butenyl]nipecotic acid hydrochloride, its molecular formula is C20H25NO2S2 HCl, and its molecular weight is 412.01. Tiagabine HCl, USP is a white to off-white powder. It is freely soluble in methanol and in alcohol, soluble in 5% Water in isopropanol, very slightly soluble in chloroform, sparingly soluble in water and practically insoluble in n-Heptane. The structural formula is. Inactive Ingredients Tiagabine hydrochloride tablets contain the following inactive ingredients: Butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil (cottonseed oil), hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, stearic acid and titanium dioxide. In addition, individual tablets contain: 2 mg tablets: FD&C yellow No. 6 aluminum lake 4 mg tablets: D&C yellow No. 10 aluminum lake 12 mg tablets: D&C yellow No. 10 aluminum lake and FD&C Blue No. 1 aluminum lake 16 mg tablets: FD&C blue No. 2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>21749-153-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (21749-153-01) </PackageDescription>
<NDC11Code>21749-0153-01</NDC11Code>
<ProductNDC>21749-153</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Purell Advanced Hand Sanitizer Holiday Spice</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121101</StartMarketingDate>
<EndMarketingDate>20190731</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>GOJO Industries, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20121101</StartMarketingDatePackage>
<EndMarketingDatePackage>20190731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>22700-153-30</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, PUMP (22700-153-30) </PackageDescription>
<NDC11Code>22700-0153-30</NDC11Code>
<ProductNDC>22700-153</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Covergirl Queen Collection All Day Flawless 3in1 Foundation</ProprietaryName>
<ProprietaryNameSuffix>Broad Spectrum Spf 20 - Q860 Rich Mink</ProprietaryNameSuffix>
<NonProprietaryName>Ensulizole</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120901</StartMarketingDate>
<EndMarketingDate>20211231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Noxell</LabelerName>
<SubstanceName>ENSULIZOLE</SubstanceName>
<StrengthNumber>.03</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120901</StartMarketingDatePackage>
<EndMarketingDatePackage>20211231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>23594-153-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-153-30) </PackageDescription>
<NDC11Code>23594-0153-30</NDC11Code>
<ProductNDC>23594-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Exxua</ProprietaryName>
<NonProprietaryName>Gepirone</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021164</ApplicationNumber>
<LabelerName>Aytu Therapeutics, LLC</LabelerName>
<SubstanceName>GEPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>72.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EXXUA is indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>EXXUA contains gepirone, in the salt form as gepirone hydrochloride (HCl). The chemical name is 2,6- piperidinedione,4,4-dimethyl-1-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-, monohydrochloride. The molecular weight of gepirone HCl is 395.93 and the structural formula is as follows. Gepirone HCl is a white to off-white crystalline powder, which is readily soluble in water. EXXUA is supplied as extended-release tablets for oral administration. Each extended-release tablet contains 18.2 mg, 36.3 mg, 54.5 mg, or 72.6 mg, gepirone equivalent to 20 mg, 40 mg, 60 mg, or 80 mg of gepirone HCl respectively. The extended-release tablets also contain the following inactive ingredients: colloidal silicon dioxide, Hypromellose, iron oxide (red and/or yellow colorants), magnesium stearate, and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>31722-153-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (31722-153-30) </PackageDescription>
<NDC11Code>31722-0153-30</NDC11Code>
<ProductNDC>31722-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210623</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203311</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1) Heart failure(NYHA class II to IV), to reduce hospitalization for heart failure in adults ( 1.2) Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults ( 1.3).</IndicationAndUsage>
<Description>Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1receptor subtype. Valsartan is chemically described as L-valine, N-(1-oxopentyl)- N-[[2′-(1 H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-. Its molecular formula is C 24H 29N 5O 3, its molecular weight is 435.52, and its structural formula is. Valsartan, USP is a white to an off-white powder. It is soluble in ethanol and methanol and insoluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan USP. The inactive ingredients of the tablets are croscarmellose sodium, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, and titanium dioxide. In addition to this 40 mg contains iron oxide yellow, 80 mg contains iron oxide red, 160 mg contains iron oxides (yellow and red) and 320 mg contains iron oxides (yellow, red and black). Meets USP dissolution test 2.</Description>
</NDC>
</NDCList>