{
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{
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"PackageDescription": "50 mL in 1 BOTTLE, GLASS (71919-363-09) ",
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"ProductTypeName": "HUMAN OTC DRUG",
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},
{
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"ProductNDC": "62257-363",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cleanse",
"NonProprietaryName": "Chloroxylenol",
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"ApplicationNumber": "part333E",
"LabelerName": "ABC Compounding Co., Inc.",
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"IndicationAndUsage": "for hand-washing to decrease bacteria on the skin."
},
{
"NDCCode": "68180-363-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (68180-363-09) ",
"NDC11Code": "68180-0363-09",
"ProductNDC": "68180-363",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Lupin Pharmaceuticals, Inc.",
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},
{
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"ProductNDC": "71919-363",
"ProductTypeName": "HUMAN OTC DRUG",
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"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "INULA HELENIUM ROOT",
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},
{
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"PackageDescription": "30 mL in 1 VIAL, GLASS (71919-363-08) ",
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"ProductNDC": "71919-363",
"ProductTypeName": "HUMAN OTC DRUG",
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"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "INULA HELENIUM ROOT",
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"StrengthUnit": "[hp_C]/mL",
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"StartMarketingDatePackage": "20100203",
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},
{
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"PackageDescription": "100 mL in 1 BOTTLE, GLASS (71919-363-10) ",
"NDC11Code": "71919-0363-10",
"ProductNDC": "71919-363",
"ProductTypeName": "HUMAN OTC DRUG",
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"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "INULA HELENIUM ROOT",
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"Status": "Deprecated",
"LastUpdate": "2022-03-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "0069-0252-30",
"PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0069-0252-30) ",
"NDC11Code": "00069-0252-30",
"ProductNDC": "0069-0252",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Talzenna",
"NonProprietaryName": "Talazoparib",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20240417",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217439",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "TALAZOPARIB TOSYLATE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240417",
"SamplePackage": "N",
"Description": "Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. TALZENNA contains talazoparib tosylate. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as liquid-filled soft gelatin capsules. Each capsule contains 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75, or 1 mg of talazoparib equivalent to 0.145 mg, 0.363 mg, 0.509 mg, 0.727 mg, 1.09 mg, or 1.453 mg talazoparib tosylate, respectively. TALZENNA capsules contain the following inactive ingredients: gelatin, glycerol, iron oxide (red), iron oxide (yellow), polyethylene glycol 400, purified water, sorbitol, titanium dioxide, and tocopherol."
},
{
"NDCCode": "0069-0296-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0069-0296-30) / 30 CAPSULE in 1 BOTTLE",
"NDC11Code": "00069-0296-30",
"ProductNDC": "0069-0296",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Talzenna",
"NonProprietaryName": "Talazoparib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181026",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211651",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "TALAZOPARIB TOSYLATE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181026",
"EndMarketingDatePackage": "20270131",
"SamplePackage": "N",
"Description": "Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as: 1 0.1 mg hard hypromellose (HPMC) capsule that contains 0.145 mg talazoparib tosylate equivalent to 0.1 mg talazoparib free base, or , 2 0.25 mg HPMC capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base, or, 3 0.35 mg HPMC capsule that contains 0.509 mg talazoparib tosylate equivalent to 0.35 mg talazoparib free base, or, 4 0.5 mg HPMC capsule that contains 0.727 mg talazoparib tosylate equivalent to 0.5 mg talazoparib free base, or, 5 0.75 mg HPMC capsule that contains 1.09 mg talazoparib tosylate equivalent to 0.75 mg talazoparib free base, or, 6 1 mg HPMC capsule that contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base."
},
{
"NDCCode": "0069-0353-30",
"PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0069-0353-30) ",
"NDC11Code": "00069-0353-30",
"ProductNDC": "0069-0353",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Talzenna",
"NonProprietaryName": "Talazoparib",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20240417",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217439",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "TALAZOPARIB TOSYLATE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240417",
"SamplePackage": "N",
"Description": "Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. TALZENNA contains talazoparib tosylate. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as liquid-filled soft gelatin capsules. Each capsule contains 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75, or 1 mg of talazoparib equivalent to 0.145 mg, 0.363 mg, 0.509 mg, 0.727 mg, 1.09 mg, or 1.453 mg talazoparib tosylate, respectively. TALZENNA capsules contain the following inactive ingredients: gelatin, glycerol, iron oxide (red), iron oxide (yellow), polyethylene glycol 400, purified water, sorbitol, titanium dioxide, and tocopherol."
},
{
"NDCCode": "0069-0454-30",
"PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0069-0454-30) ",
"NDC11Code": "00069-0454-30",
"ProductNDC": "0069-0454",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Talzenna",
"NonProprietaryName": "Talazoparib",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20240417",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217439",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "TALAZOPARIB TOSYLATE",
"StrengthNumber": ".35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240417",
"SamplePackage": "N",
"Description": "Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. TALZENNA contains talazoparib tosylate. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as liquid-filled soft gelatin capsules. Each capsule contains 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75, or 1 mg of talazoparib equivalent to 0.145 mg, 0.363 mg, 0.509 mg, 0.727 mg, 1.09 mg, or 1.453 mg talazoparib tosylate, respectively. TALZENNA capsules contain the following inactive ingredients: gelatin, glycerol, iron oxide (red), iron oxide (yellow), polyethylene glycol 400, purified water, sorbitol, titanium dioxide, and tocopherol."
},
{
"NDCCode": "0069-0546-30",
"PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0069-0546-30) ",
"NDC11Code": "00069-0546-30",
"ProductNDC": "0069-0546",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Talzenna",
"NonProprietaryName": "Talazoparib",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20240417",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217439",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "TALAZOPARIB TOSYLATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240417",
"SamplePackage": "N",
"Description": "Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. TALZENNA contains talazoparib tosylate. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as liquid-filled soft gelatin capsules. Each capsule contains 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75, or 1 mg of talazoparib equivalent to 0.145 mg, 0.363 mg, 0.509 mg, 0.727 mg, 1.09 mg, or 1.453 mg talazoparib tosylate, respectively. TALZENNA capsules contain the following inactive ingredients: gelatin, glycerol, iron oxide (red), iron oxide (yellow), polyethylene glycol 400, purified water, sorbitol, titanium dioxide, and tocopherol."
},
{
"NDCCode": "0069-0655-30",
"PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0069-0655-30) ",
"NDC11Code": "00069-0655-30",
"ProductNDC": "0069-0655",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Talzenna",
"NonProprietaryName": "Talazoparib",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20240417",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217439",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "TALAZOPARIB TOSYLATE",
"StrengthNumber": ".75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240417",
"SamplePackage": "N",
"Description": "Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. TALZENNA contains talazoparib tosylate. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as liquid-filled soft gelatin capsules. Each capsule contains 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75, or 1 mg of talazoparib equivalent to 0.145 mg, 0.363 mg, 0.509 mg, 0.727 mg, 1.09 mg, or 1.453 mg talazoparib tosylate, respectively. TALZENNA capsules contain the following inactive ingredients: gelatin, glycerol, iron oxide (red), iron oxide (yellow), polyethylene glycol 400, purified water, sorbitol, titanium dioxide, and tocopherol."
},
{
"NDCCode": "0069-0757-30",
"PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0069-0757-30) ",
"NDC11Code": "00069-0757-30",
"ProductNDC": "0069-0757",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Talzenna",
"NonProprietaryName": "Talazoparib",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20240417",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217439",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "TALAZOPARIB TOSYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240417",
"SamplePackage": "N",
"Description": "Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. TALZENNA contains talazoparib tosylate. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as liquid-filled soft gelatin capsules. Each capsule contains 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75, or 1 mg of talazoparib equivalent to 0.145 mg, 0.363 mg, 0.509 mg, 0.727 mg, 1.09 mg, or 1.453 mg talazoparib tosylate, respectively. TALZENNA capsules contain the following inactive ingredients: gelatin, glycerol, iron oxide (red), iron oxide (yellow), polyethylene glycol 400, purified water, sorbitol, titanium dioxide, and tocopherol."
},
{
"NDCCode": "0069-1031-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0069-1031-30) / 30 CAPSULE in 1 BOTTLE",
"NDC11Code": "00069-1031-30",
"ProductNDC": "0069-1031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Talzenna",
"NonProprietaryName": "Talazoparib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230621",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211651",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "TALAZOPARIB TOSYLATE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230621",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"Description": "Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as: 1 0.1 mg hard hypromellose (HPMC) capsule that contains 0.145 mg talazoparib tosylate equivalent to 0.1 mg talazoparib free base, or , 2 0.25 mg HPMC capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base, or, 3 0.35 mg HPMC capsule that contains 0.509 mg talazoparib tosylate equivalent to 0.35 mg talazoparib free base, or, 4 0.5 mg HPMC capsule that contains 0.727 mg talazoparib tosylate equivalent to 0.5 mg talazoparib free base, or, 5 0.75 mg HPMC capsule that contains 1.09 mg talazoparib tosylate equivalent to 0.75 mg talazoparib free base, or, 6 1 mg HPMC capsule that contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base."
},
{
"NDCCode": "0069-1195-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0069-1195-30) / 30 CAPSULE in 1 BOTTLE",
"NDC11Code": "00069-1195-30",
"ProductNDC": "0069-1195",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Talzenna",
"NonProprietaryName": "Talazoparib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181026",
"EndMarketingDate": "20270831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211651",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "TALAZOPARIB TOSYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181026",
"EndMarketingDatePackage": "20270831",
"SamplePackage": "N",
"Description": "Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as: 1 0.1 mg hard hypromellose (HPMC) capsule that contains 0.145 mg talazoparib tosylate equivalent to 0.1 mg talazoparib free base, or , 2 0.25 mg HPMC capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base, or, 3 0.35 mg HPMC capsule that contains 0.509 mg talazoparib tosylate equivalent to 0.35 mg talazoparib free base, or, 4 0.5 mg HPMC capsule that contains 0.727 mg talazoparib tosylate equivalent to 0.5 mg talazoparib free base, or, 5 0.75 mg HPMC capsule that contains 1.09 mg talazoparib tosylate equivalent to 0.75 mg talazoparib free base, or, 6 1 mg HPMC capsule that contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base."
},
{
"NDCCode": "0069-1235-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0069-1235-30) / 30 CAPSULE in 1 BOTTLE",
"NDC11Code": "00069-1235-30",
"ProductNDC": "0069-1235",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Talzenna",
"NonProprietaryName": "Talazoparib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230621",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211651",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "TALAZOPARIB TOSYLATE",
"StrengthNumber": ".35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230621",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"Description": "Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as: 1 0.1 mg hard hypromellose (HPMC) capsule that contains 0.145 mg talazoparib tosylate equivalent to 0.1 mg talazoparib free base, or , 2 0.25 mg HPMC capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base, or, 3 0.35 mg HPMC capsule that contains 0.509 mg talazoparib tosylate equivalent to 0.35 mg talazoparib free base, or, 4 0.5 mg HPMC capsule that contains 0.727 mg talazoparib tosylate equivalent to 0.5 mg talazoparib free base, or, 5 0.75 mg HPMC capsule that contains 1.09 mg talazoparib tosylate equivalent to 0.75 mg talazoparib free base, or, 6 1 mg HPMC capsule that contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base."
},
{
"NDCCode": "0069-1501-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0069-1501-30) / 30 CAPSULE in 1 BOTTLE",
"NDC11Code": "00069-1501-30",
"ProductNDC": "0069-1501",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Talzenna",
"NonProprietaryName": "Talazoparib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220131",
"EndMarketingDate": "20270331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211651",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "TALAZOPARIB TOSYLATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220131",
"EndMarketingDatePackage": "20270331",
"SamplePackage": "N",
"Description": "Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as: 1 0.1 mg hard hypromellose (HPMC) capsule that contains 0.145 mg talazoparib tosylate equivalent to 0.1 mg talazoparib free base, or , 2 0.25 mg HPMC capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base, or, 3 0.35 mg HPMC capsule that contains 0.509 mg talazoparib tosylate equivalent to 0.35 mg talazoparib free base, or, 4 0.5 mg HPMC capsule that contains 0.727 mg talazoparib tosylate equivalent to 0.5 mg talazoparib free base, or, 5 0.75 mg HPMC capsule that contains 1.09 mg talazoparib tosylate equivalent to 0.75 mg talazoparib free base, or, 6 1 mg HPMC capsule that contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base."
},
{
"NDCCode": "0069-1751-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0069-1751-30) / 30 CAPSULE in 1 BOTTLE",
"NDC11Code": "00069-1751-30",
"ProductNDC": "0069-1751",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Talzenna",
"NonProprietaryName": "Talazoparib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220131",
"EndMarketingDate": "20251130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211651",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "TALAZOPARIB TOSYLATE",
"StrengthNumber": ".75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220131",
"EndMarketingDatePackage": "20251130",
"SamplePackage": "N",
"Description": "Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as: 1 0.1 mg hard hypromellose (HPMC) capsule that contains 0.145 mg talazoparib tosylate equivalent to 0.1 mg talazoparib free base, or , 2 0.25 mg HPMC capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base, or, 3 0.35 mg HPMC capsule that contains 0.509 mg talazoparib tosylate equivalent to 0.35 mg talazoparib free base, or, 4 0.5 mg HPMC capsule that contains 0.727 mg talazoparib tosylate equivalent to 0.5 mg talazoparib free base, or, 5 0.75 mg HPMC capsule that contains 1.09 mg talazoparib tosylate equivalent to 0.75 mg talazoparib free base, or, 6 1 mg HPMC capsule that contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base."
},
{
"NDCCode": "0404-9923-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9923-01) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00404-9923-01",
"ProductNDC": "0404-9923",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naloxone Hydrochloride",
"NonProprietaryName": "Naloxone Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20220113",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207633",
"LabelerName": "Henry Schein, Inc.",
"SubstanceName": "NALOXONE HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220113",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "Naloxone Hydrochloride Injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY; ADJUNCTIVE USE IN SEPTIC SHOCK).",
"Description": "Naloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of naloxone hydrochloride in water for injection. Each milliliter (mL) contains 0.4 mg naloxone hydrochloride and sodium chloride to adjust tonicity in water for injection. May contain hydrochloric acid for pH adjustment; pH 4.0 (3.0 to 6.5). The single-dose solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required, the unused portion should be discarded. Naloxone Hydrochloride Injection, USP may be administered intravenously, intramuscularly, or subcutaneously. Naloxone, an opioid antagonist, is a synthetic congener of oxymorphone. It differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. Naloxone Hydrochloride, USP is chemically designated 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride (C19H21NO4 HCl), a white to slightly off-white powder soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and chloroform. It has a molecular weight of 363.84. It has the following structural formula."
},
{
"NDCCode": "0641-6193-10",
"PackageDescription": "10 SYRINGE in 1 CARTON (0641-6193-10) / 1 mL in 1 SYRINGE (0641-6193-01) ",
"NDC11Code": "00641-6193-10",
"ProductNDC": "0641-6193",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naloxone Hydrochloride",
"NonProprietaryName": "Naloxone Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20250725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212300",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "NALOXONE HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "Naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY, Adjunctive Use in Septic Shock).",
"Description": "Naloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of naloxone hydrochloride in water for injection. Each milliliter (mL) in the 1 mL single dose syringe contains 0.4 mg (400 micrograms) of naloxone hydrochloride, 8.9 mg of sodium chloride to adjust tonicity, in Water for Injection. Each milliliter (mL) in the 2 mL single dose syringe contains 1 mg of naloxone hydrochloride, 8.35 mg of sodium chloride to adjust tonicity, in Water for Injection. The pH is 3.0-4.0 with hydrochloric acid used, if needed, for pH adjustment. Sealed under nitrogen. Naloxone Hydrochloride Injection, USP may be administered intravenously, intramuscularly, or subcutaneously. Naloxone, an opioid antagonist, is a synthetic congener of oxymorphone. It differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. Naloxone Hydrochloride, USP is a chemically designated 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride (C19H21NO4 HCl), a white to slightly off-white powder soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and chloroform. It has a molecular weight of 363.84. It has the following structural formula."
},
{
"NDCCode": "0641-6205-10",
"PackageDescription": "10 SYRINGE in 1 CARTON (0641-6205-10) / 2 mL in 1 SYRINGE (0641-6205-01) ",
"NDC11Code": "00641-6205-10",
"ProductNDC": "0641-6205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naloxone Hydrochloride",
"NonProprietaryName": "Naloxone Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20220610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212300",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "NALOXONE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220610",
"SamplePackage": "N",
"IndicationAndUsage": "Naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY, Adjunctive Use in Septic Shock).",
"Description": "Naloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of naloxone hydrochloride in water for injection. Each milliliter (mL) in the 1 mL single dose syringe contains 0.4 mg (400 micrograms) of naloxone hydrochloride, 8.9 mg of sodium chloride to adjust tonicity, in Water for Injection. Each milliliter (mL) in the 2 mL single dose syringe contains 1 mg of naloxone hydrochloride, 8.35 mg of sodium chloride to adjust tonicity, in Water for Injection. The pH is 3.0-4.0 with hydrochloric acid used, if needed, for pH adjustment. Sealed under nitrogen. Naloxone Hydrochloride Injection, USP may be administered intravenously, intramuscularly, or subcutaneously. Naloxone, an opioid antagonist, is a synthetic congener of oxymorphone. It differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. Naloxone Hydrochloride, USP is a chemically designated 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride (C19H21NO4 HCl), a white to slightly off-white powder soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and chloroform. It has a molecular weight of 363.84. It has the following structural formula."
},
{
"NDCCode": "11819-363-00",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (11819-363-00)",
"NDC11Code": "11819-0363-00",
"ProductNDC": "11819-363",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075817",
"LabelerName": "HHS/Program Support Center/Supply Service Center",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ciprofloxacin tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations.",
"Description": "Ciprofloxacin tablets, USP are a synthetic broad spectrum antimicrobial agent for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3 ∙HCl ∙H2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg or 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin tablets are white. The inactive ingredients are: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide and triacetin."
},
{
"NDCCode": "13537-363-01",
"PackageDescription": "80 g in 1 BOTTLE (13537-363-01)",
"NDC11Code": "13537-0363-01",
"ProductNDC": "13537-363",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika",
"ProprietaryNameSuffix": "Perfect Sun Kids",
"NonProprietaryName": "Ensulizole, Octinoxate, Octisalate, Octocrylene, Oxybenzone, And Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110530",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation (San Juan, P.R)",
"SubstanceName": "ENSULIZOLE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE",
"StrengthNumber": ".03; .075; .05; .07; .6; .0468",
"StrengthUnit": "g/g; g/g; g/g; g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "helps prevent sunburn. higher SPF gives more sunburn protection."
},
{
"NDCCode": "13537-363-02",
"PackageDescription": "1 g in 1 BOTTLE (13537-363-02)",
"NDC11Code": "13537-0363-02",
"ProductNDC": "13537-363",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika",
"ProprietaryNameSuffix": "Perfect Sun Kids",
"NonProprietaryName": "Ensulizole, Octinoxate, Octisalate, Octocrylene, Oxybenzone, And Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110530",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation (San Juan, P.R)",
"SubstanceName": "ENSULIZOLE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE",
"StrengthNumber": ".03; .075; .05; .07; .6; .0468",
"StrengthUnit": "g/g; g/g; g/g; g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "helps prevent sunburn. higher SPF gives more sunburn protection."
},
{
"NDCCode": "21695-363-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (21695-363-30)",
"NDC11Code": "21695-0363-30",
"ProductNDC": "21695-363",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flurazepam",
"NonProprietaryName": "Flurazepam Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19861208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071108",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "FLURAZEPAM HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Flurazepam Hydrochloride Capsules are a hypnotic agent useful for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakening. Flurazepam Hydrochloride Capsules can be used effectively in patients with recurring insomnia or poor sleeping habits, and in acute or chronic medical situations requiring restful sleep. Sleep laboratory studies have objectively determined that Flurazepam Hydrochloride Capsules are effective for at least 28 consecutive nights of drug administration. Since insomnia is often transient and intermittent short-term use is usually sufficient. Prolonged use of hypnotics is usually not indicated and should only be undertaken concomitantly with appropriate evaluation of the patient.",
"Description": "Flurazepam hydrochloride is chemically 7-chloro-1-[2(diethylamino)ethyl]-5-(o-fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one dihydrochloride. It is a pale yellow, crystalline compound, freely soluble in alcohol and very soluble in water. It has a molecular weight of 460.81 and the following structural formula. Each capsule, for oral administration, contains 15 mg or 30 mg of flurazepam hydrochloride. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, magnesium stearate, pregelatinized starch , and sodium starch glycolate. Capsules shells may contain: colloidal silicon dioxide, FD&C Blue No. 1, FD&C Red No. 3, gelatin, silicon dioxide, sodium lauryl sulfate, and titanium dioxide."
},
{
"NDCCode": "21749-363-79",
"PackageDescription": "100 PACKET in 1 CARTON (21749-363-79) > 1 APPLICATOR in 1 PACKET (21749-363-76) > 1.75 mL in 1 APPLICATOR",
"NDC11Code": "21749-0363-79",
"ProductNDC": "21749-363",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Purell Sanitizing Hand Wipes",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070122",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "GOJO Industries, Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".62",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "37000-363-45",
"PackageDescription": "45 g in 1 CANISTER (37000-363-45) ",
"NDC11Code": "37000-0363-45",
"ProductNDC": "37000-363",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Secret Clinical",
"ProprietaryNameSuffix": "Clear Completely Clean",
"NonProprietaryName": "Aluminum Zirconium Octachlorohydrex Gly",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY",
"StrengthNumber": ".2",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2018-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20131101",
"EndMarketingDatePackage": "20180405",
"SamplePackage": "N"
},
{
"NDCCode": "37000-363-73",
"PackageDescription": "73 g in 1 CANISTER (37000-363-73) ",
"NDC11Code": "37000-0363-73",
"ProductNDC": "37000-363",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Secret Clinical",
"ProprietaryNameSuffix": "Clear Completely Clean",
"NonProprietaryName": "Aluminum Zirconium Octachlorohydrex Gly",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY",
"StrengthNumber": ".2",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2018-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20131101",
"EndMarketingDatePackage": "20180405",
"SamplePackage": "N"
},
{
"NDCCode": "37205-363-74",
"PackageDescription": "14 POUCH in 1 CARTON (37205-363-74) > 1 PATCH in 1 POUCH > 24 h in 1 PATCH",
"NDC11Code": "37205-0363-74",
"ProductNDC": "37205-363",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Nicotine Transdermal System",
"ProprietaryNameSuffix": "Step 3",
"NonProprietaryName": "Nicotine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120102",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020076",
"LabelerName": "Cardinal Health",
"SubstanceName": "NICOTINE",
"StrengthNumber": "7",
"StrengthUnit": "mg/24h",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "50742-363-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50742-363-60) ",
"NDC11Code": "50742-0363-60",
"ProductNDC": "50742-363",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ivabradine",
"NonProprietaryName": "Ivabradine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214051",
"LabelerName": "Ingenus Pharmaceuticals, LLC",
"SubstanceName": "IVABRADINE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240715",
"SamplePackage": "N",
"IndicationAndUsage": "Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: 1 To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. (1.1).",
"Description": "Ivabradine tablets contains ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. The chemical name for ivabradine hydrochloride is. 3-(3-{[((7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl] methyl amino} propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one,hydrochloride.The molecular formula is C27 H36 N2O5· HCl, and the molecular weight (free base +HCl) is 505.1 (468.6 + 36.5). The chemical structure of ivabradine is shown in Figure 1. Figure 1. Chemical Structure of Ivabradine. Tablets. Ivabradine tablets are supplied in 5 mg and 7.5 mg tablets for oral administration. The tablets contain 5 mg and 7.5 mg of ivabradine, as active ingredient, equivalent to 5.39 mg and 8.09 mg of ivabradine hydrochloride, respectively. The tablets contain the following inactive ingredients: lactose monohydrate, maltodextrin, maize starch b, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol 4000, yellow iron oxide and red iron oxide."
}
]
}
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<NDCCode>71919-363-09</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE, GLASS (71919-363-09) </PackageDescription>
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<ProductNDC>71919-363</ProductNDC>
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<ProprietaryName>Inula Helenium</ProprietaryName>
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<NDC>
<NDCCode>62257-363-09</NDCCode>
<PackageDescription>2000 mL in 1 CARTRIDGE (62257-363-09)</PackageDescription>
<NDC11Code>62257-0363-09</NDC11Code>
<ProductNDC>62257-363</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cleanse</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20101101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>ABC Compounding Co., Inc.</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for hand-washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68180-363-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (68180-363-09) </PackageDescription>
<NDC11Code>68180-0363-09</NDC11Code>
<ProductNDC>68180-363</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151123</StartMarketingDate>
<EndMarketingDate>20220531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204019</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20151123</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-363-07</NDCCode>
<PackageDescription>15 mL in 1 VIAL, GLASS (71919-363-07) </PackageDescription>
<NDC11Code>71919-0363-07</NDC11Code>
<ProductNDC>71919-363</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Inula Helenium</ProprietaryName>
<NonProprietaryName>Inula Helenium Root</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>INULA HELENIUM ROOT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-363-08</NDCCode>
<PackageDescription>30 mL in 1 VIAL, GLASS (71919-363-08) </PackageDescription>
<NDC11Code>71919-0363-08</NDC11Code>
<ProductNDC>71919-363</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Inula Helenium</ProprietaryName>
<NonProprietaryName>Inula Helenium Root</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>INULA HELENIUM ROOT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71919-363-10</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, GLASS (71919-363-10) </PackageDescription>
<NDC11Code>71919-0363-10</NDC11Code>
<ProductNDC>71919-363</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Inula Helenium</ProprietaryName>
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<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>INULA HELENIUM ROOT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0069-0252-30</NDCCode>
<PackageDescription>30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0069-0252-30) </PackageDescription>
<NDC11Code>00069-0252-30</NDC11Code>
<ProductNDC>0069-0252</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Talzenna</ProprietaryName>
<NonProprietaryName>Talazoparib</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240417</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217439</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>TALAZOPARIB TOSYLATE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. TALZENNA contains talazoparib tosylate. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as liquid-filled soft gelatin capsules. Each capsule contains 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75, or 1 mg of talazoparib equivalent to 0.145 mg, 0.363 mg, 0.509 mg, 0.727 mg, 1.09 mg, or 1.453 mg talazoparib tosylate, respectively. TALZENNA capsules contain the following inactive ingredients: gelatin, glycerol, iron oxide (red), iron oxide (yellow), polyethylene glycol 400, purified water, sorbitol, titanium dioxide, and tocopherol.</Description>
</NDC>
<NDC>
<NDCCode>0069-0296-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0069-0296-30) / 30 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>00069-0296-30</NDC11Code>
<ProductNDC>0069-0296</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Talzenna</ProprietaryName>
<NonProprietaryName>Talazoparib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181026</StartMarketingDate>
<EndMarketingDate>20270131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211651</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>TALAZOPARIB TOSYLATE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181026</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as: 1 0.1 mg hard hypromellose (HPMC) capsule that contains 0.145 mg talazoparib tosylate equivalent to 0.1 mg talazoparib free base, or , 2 0.25 mg HPMC capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base, or, 3 0.35 mg HPMC capsule that contains 0.509 mg talazoparib tosylate equivalent to 0.35 mg talazoparib free base, or, 4 0.5 mg HPMC capsule that contains 0.727 mg talazoparib tosylate equivalent to 0.5 mg talazoparib free base, or, 5 0.75 mg HPMC capsule that contains 1.09 mg talazoparib tosylate equivalent to 0.75 mg talazoparib free base, or, 6 1 mg HPMC capsule that contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base.</Description>
</NDC>
<NDC>
<NDCCode>0069-0353-30</NDCCode>
<PackageDescription>30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0069-0353-30) </PackageDescription>
<NDC11Code>00069-0353-30</NDC11Code>
<ProductNDC>0069-0353</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Talzenna</ProprietaryName>
<NonProprietaryName>Talazoparib</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240417</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217439</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>TALAZOPARIB TOSYLATE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. TALZENNA contains talazoparib tosylate. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as liquid-filled soft gelatin capsules. Each capsule contains 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75, or 1 mg of talazoparib equivalent to 0.145 mg, 0.363 mg, 0.509 mg, 0.727 mg, 1.09 mg, or 1.453 mg talazoparib tosylate, respectively. TALZENNA capsules contain the following inactive ingredients: gelatin, glycerol, iron oxide (red), iron oxide (yellow), polyethylene glycol 400, purified water, sorbitol, titanium dioxide, and tocopherol.</Description>
</NDC>
<NDC>
<NDCCode>0069-0454-30</NDCCode>
<PackageDescription>30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0069-0454-30) </PackageDescription>
<NDC11Code>00069-0454-30</NDC11Code>
<ProductNDC>0069-0454</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Talzenna</ProprietaryName>
<NonProprietaryName>Talazoparib</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240417</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217439</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
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<Description>Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. TALZENNA contains talazoparib tosylate. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as liquid-filled soft gelatin capsules. Each capsule contains 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75, or 1 mg of talazoparib equivalent to 0.145 mg, 0.363 mg, 0.509 mg, 0.727 mg, 1.09 mg, or 1.453 mg talazoparib tosylate, respectively. TALZENNA capsules contain the following inactive ingredients: gelatin, glycerol, iron oxide (red), iron oxide (yellow), polyethylene glycol 400, purified water, sorbitol, titanium dioxide, and tocopherol.</Description>
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<Description>Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. TALZENNA contains talazoparib tosylate. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as liquid-filled soft gelatin capsules. Each capsule contains 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75, or 1 mg of talazoparib equivalent to 0.145 mg, 0.363 mg, 0.509 mg, 0.727 mg, 1.09 mg, or 1.453 mg talazoparib tosylate, respectively. TALZENNA capsules contain the following inactive ingredients: gelatin, glycerol, iron oxide (red), iron oxide (yellow), polyethylene glycol 400, purified water, sorbitol, titanium dioxide, and tocopherol.</Description>
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<Description>Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. TALZENNA contains talazoparib tosylate. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as liquid-filled soft gelatin capsules. Each capsule contains 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75, or 1 mg of talazoparib equivalent to 0.145 mg, 0.363 mg, 0.509 mg, 0.727 mg, 1.09 mg, or 1.453 mg talazoparib tosylate, respectively. TALZENNA capsules contain the following inactive ingredients: gelatin, glycerol, iron oxide (red), iron oxide (yellow), polyethylene glycol 400, purified water, sorbitol, titanium dioxide, and tocopherol.</Description>
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<Description>Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. TALZENNA contains talazoparib tosylate. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as liquid-filled soft gelatin capsules. Each capsule contains 0.1 mg, 0.25 mg, 0.35 mg, 0.5 mg, 0.75, or 1 mg of talazoparib equivalent to 0.145 mg, 0.363 mg, 0.509 mg, 0.727 mg, 1.09 mg, or 1.453 mg talazoparib tosylate, respectively. TALZENNA capsules contain the following inactive ingredients: gelatin, glycerol, iron oxide (red), iron oxide (yellow), polyethylene glycol 400, purified water, sorbitol, titanium dioxide, and tocopherol.</Description>
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<Description>Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as: 1 0.1 mg hard hypromellose (HPMC) capsule that contains 0.145 mg talazoparib tosylate equivalent to 0.1 mg talazoparib free base, or , 2 0.25 mg HPMC capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base, or, 3 0.35 mg HPMC capsule that contains 0.509 mg talazoparib tosylate equivalent to 0.35 mg talazoparib free base, or, 4 0.5 mg HPMC capsule that contains 0.727 mg talazoparib tosylate equivalent to 0.5 mg talazoparib free base, or, 5 0.75 mg HPMC capsule that contains 1.09 mg talazoparib tosylate equivalent to 0.75 mg talazoparib free base, or, 6 1 mg HPMC capsule that contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base.</Description>
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<Description>Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as: 1 0.1 mg hard hypromellose (HPMC) capsule that contains 0.145 mg talazoparib tosylate equivalent to 0.1 mg talazoparib free base, or , 2 0.25 mg HPMC capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base, or, 3 0.35 mg HPMC capsule that contains 0.509 mg talazoparib tosylate equivalent to 0.35 mg talazoparib free base, or, 4 0.5 mg HPMC capsule that contains 0.727 mg talazoparib tosylate equivalent to 0.5 mg talazoparib free base, or, 5 0.75 mg HPMC capsule that contains 1.09 mg talazoparib tosylate equivalent to 0.75 mg talazoparib free base, or, 6 1 mg HPMC capsule that contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base.</Description>
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<Description>Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as: 1 0.1 mg hard hypromellose (HPMC) capsule that contains 0.145 mg talazoparib tosylate equivalent to 0.1 mg talazoparib free base, or , 2 0.25 mg HPMC capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base, or, 3 0.35 mg HPMC capsule that contains 0.509 mg talazoparib tosylate equivalent to 0.35 mg talazoparib free base, or, 4 0.5 mg HPMC capsule that contains 0.727 mg talazoparib tosylate equivalent to 0.5 mg talazoparib free base, or, 5 0.75 mg HPMC capsule that contains 1.09 mg talazoparib tosylate equivalent to 0.75 mg talazoparib free base, or, 6 1 mg HPMC capsule that contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base.</Description>
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<Description>Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as: 1 0.1 mg hard hypromellose (HPMC) capsule that contains 0.145 mg talazoparib tosylate equivalent to 0.1 mg talazoparib free base, or , 2 0.25 mg HPMC capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base, or, 3 0.35 mg HPMC capsule that contains 0.509 mg talazoparib tosylate equivalent to 0.35 mg talazoparib free base, or, 4 0.5 mg HPMC capsule that contains 0.727 mg talazoparib tosylate equivalent to 0.5 mg talazoparib free base, or, 5 0.75 mg HPMC capsule that contains 1.09 mg talazoparib tosylate equivalent to 0.75 mg talazoparib free base, or, 6 1 mg HPMC capsule that contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base.</Description>
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<Description>Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as: 1 0.1 mg hard hypromellose (HPMC) capsule that contains 0.145 mg talazoparib tosylate equivalent to 0.1 mg talazoparib free base, or , 2 0.25 mg HPMC capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base, or, 3 0.35 mg HPMC capsule that contains 0.509 mg talazoparib tosylate equivalent to 0.35 mg talazoparib free base, or, 4 0.5 mg HPMC capsule that contains 0.727 mg talazoparib tosylate equivalent to 0.5 mg talazoparib free base, or, 5 0.75 mg HPMC capsule that contains 1.09 mg talazoparib tosylate equivalent to 0.75 mg talazoparib free base, or, 6 1 mg HPMC capsule that contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base.</Description>
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<ApplicationNumber>ANDA207633</ApplicationNumber>
<LabelerName>Henry Schein, Inc.</LabelerName>
<SubstanceName>NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220113</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naloxone Hydrochloride Injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY; ADJUNCTIVE USE IN SEPTIC SHOCK).</IndicationAndUsage>
<Description>Naloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of naloxone hydrochloride in water for injection. Each milliliter (mL) contains 0.4 mg naloxone hydrochloride and sodium chloride to adjust tonicity in water for injection. May contain hydrochloric acid for pH adjustment; pH 4.0 (3.0 to 6.5). The single-dose solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required, the unused portion should be discarded. Naloxone Hydrochloride Injection, USP may be administered intravenously, intramuscularly, or subcutaneously. Naloxone, an opioid antagonist, is a synthetic congener of oxymorphone. It differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. Naloxone Hydrochloride, USP is chemically designated 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride (C19H21NO4 HCl), a white to slightly off-white powder soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and chloroform. It has a molecular weight of 363.84. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0641-6193-10</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (0641-6193-10) / 1 mL in 1 SYRINGE (0641-6193-01) </PackageDescription>
<NDC11Code>00641-6193-10</NDC11Code>
<ProductNDC>0641-6193</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naloxone Hydrochloride</ProprietaryName>
<NonProprietaryName>Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212300</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY, Adjunctive Use in Septic Shock).</IndicationAndUsage>
<Description>Naloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of naloxone hydrochloride in water for injection. Each milliliter (mL) in the 1 mL single dose syringe contains 0.4 mg (400 micrograms) of naloxone hydrochloride, 8.9 mg of sodium chloride to adjust tonicity, in Water for Injection. Each milliliter (mL) in the 2 mL single dose syringe contains 1 mg of naloxone hydrochloride, 8.35 mg of sodium chloride to adjust tonicity, in Water for Injection. The pH is 3.0-4.0 with hydrochloric acid used, if needed, for pH adjustment. Sealed under nitrogen. Naloxone Hydrochloride Injection, USP may be administered intravenously, intramuscularly, or subcutaneously. Naloxone, an opioid antagonist, is a synthetic congener of oxymorphone. It differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. Naloxone Hydrochloride, USP is a chemically designated 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride (C19H21NO4 HCl), a white to slightly off-white powder soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and chloroform. It has a molecular weight of 363.84. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0641-6205-10</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (0641-6205-10) / 2 mL in 1 SYRINGE (0641-6205-01) </PackageDescription>
<NDC11Code>00641-6205-10</NDC11Code>
<ProductNDC>0641-6205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naloxone Hydrochloride</ProprietaryName>
<NonProprietaryName>Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20220610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212300</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY, Adjunctive Use in Septic Shock).</IndicationAndUsage>
<Description>Naloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of naloxone hydrochloride in water for injection. Each milliliter (mL) in the 1 mL single dose syringe contains 0.4 mg (400 micrograms) of naloxone hydrochloride, 8.9 mg of sodium chloride to adjust tonicity, in Water for Injection. Each milliliter (mL) in the 2 mL single dose syringe contains 1 mg of naloxone hydrochloride, 8.35 mg of sodium chloride to adjust tonicity, in Water for Injection. The pH is 3.0-4.0 with hydrochloric acid used, if needed, for pH adjustment. Sealed under nitrogen. Naloxone Hydrochloride Injection, USP may be administered intravenously, intramuscularly, or subcutaneously. Naloxone, an opioid antagonist, is a synthetic congener of oxymorphone. It differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. Naloxone Hydrochloride, USP is a chemically designated 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride (C19H21NO4 HCl), a white to slightly off-white powder soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and chloroform. It has a molecular weight of 363.84. It has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>11819-363-00</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (11819-363-00)</PackageDescription>
<NDC11Code>11819-0363-00</NDC11Code>
<ProductNDC>11819-363</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075817</ApplicationNumber>
<LabelerName>HHS/Program Support Center/Supply Service Center</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ciprofloxacin tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations.</IndicationAndUsage>
<Description>Ciprofloxacin tablets, USP are a synthetic broad spectrum antimicrobial agent for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3 ∙HCl ∙H2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg or 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin tablets are white. The inactive ingredients are: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>13537-363-01</NDCCode>
<PackageDescription>80 g in 1 BOTTLE (13537-363-01)</PackageDescription>
<NDC11Code>13537-0363-01</NDC11Code>
<ProductNDC>13537-363</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika</ProprietaryName>
<ProprietaryNameSuffix>Perfect Sun Kids</ProprietaryNameSuffix>
<NonProprietaryName>Ensulizole, Octinoxate, Octisalate, Octocrylene, Oxybenzone, And Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110530</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation (San Juan, P.R)</LabelerName>
<SubstanceName>ENSULIZOLE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.03; .075; .05; .07; .6; .0468</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g; g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent sunburn. higher SPF gives more sunburn protection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13537-363-02</NDCCode>
<PackageDescription>1 g in 1 BOTTLE (13537-363-02)</PackageDescription>
<NDC11Code>13537-0363-02</NDC11Code>
<ProductNDC>13537-363</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika</ProprietaryName>
<ProprietaryNameSuffix>Perfect Sun Kids</ProprietaryNameSuffix>
<NonProprietaryName>Ensulizole, Octinoxate, Octisalate, Octocrylene, Oxybenzone, And Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110530</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation (San Juan, P.R)</LabelerName>
<SubstanceName>ENSULIZOLE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>.03; .075; .05; .07; .6; .0468</StrengthNumber>
<StrengthUnit>g/g; g/g; g/g; g/g; g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent sunburn. higher SPF gives more sunburn protection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21695-363-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (21695-363-30)</PackageDescription>
<NDC11Code>21695-0363-30</NDC11Code>
<ProductNDC>21695-363</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flurazepam</ProprietaryName>
<NonProprietaryName>Flurazepam Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19861208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071108</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>FLURAZEPAM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Flurazepam Hydrochloride Capsules are a hypnotic agent useful for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakening. Flurazepam Hydrochloride Capsules can be used effectively in patients with recurring insomnia or poor sleeping habits, and in acute or chronic medical situations requiring restful sleep. Sleep laboratory studies have objectively determined that Flurazepam Hydrochloride Capsules are effective for at least 28 consecutive nights of drug administration. Since insomnia is often transient and intermittent short-term use is usually sufficient. Prolonged use of hypnotics is usually not indicated and should only be undertaken concomitantly with appropriate evaluation of the patient.</IndicationAndUsage>
<Description>Flurazepam hydrochloride is chemically 7-chloro-1-[2(diethylamino)ethyl]-5-(o-fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one dihydrochloride. It is a pale yellow, crystalline compound, freely soluble in alcohol and very soluble in water. It has a molecular weight of 460.81 and the following structural formula. Each capsule, for oral administration, contains 15 mg or 30 mg of flurazepam hydrochloride. In addition, each capsule contains the following inactive ingredients: lactose monohydrate, magnesium stearate, pregelatinized starch , and sodium starch glycolate. Capsules shells may contain: colloidal silicon dioxide, FD&C Blue No. 1, FD&C Red No. 3, gelatin, silicon dioxide, sodium lauryl sulfate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21749-363-79</NDCCode>
<PackageDescription>100 PACKET in 1 CARTON (21749-363-79) > 1 APPLICATOR in 1 PACKET (21749-363-76) > 1.75 mL in 1 APPLICATOR</PackageDescription>
<NDC11Code>21749-0363-79</NDC11Code>
<ProductNDC>21749-363</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Purell Sanitizing Hand Wipes</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20070122</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>GOJO Industries, Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.62</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>37000-363-45</NDCCode>
<PackageDescription>45 g in 1 CANISTER (37000-363-45) </PackageDescription>
<NDC11Code>37000-0363-45</NDC11Code>
<ProductNDC>37000-363</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Secret Clinical</ProprietaryName>
<ProprietaryNameSuffix>Clear Completely Clean</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Octachlorohydrex Gly</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131101</StartMarketingDatePackage>
<EndMarketingDatePackage>20180405</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37000-363-73</NDCCode>
<PackageDescription>73 g in 1 CANISTER (37000-363-73) </PackageDescription>
<NDC11Code>37000-0363-73</NDC11Code>
<ProductNDC>37000-363</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Secret Clinical</ProprietaryName>
<ProprietaryNameSuffix>Clear Completely Clean</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Octachlorohydrex Gly</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131101</StartMarketingDatePackage>
<EndMarketingDatePackage>20180405</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37205-363-74</NDCCode>
<PackageDescription>14 POUCH in 1 CARTON (37205-363-74) > 1 PATCH in 1 POUCH > 24 h in 1 PATCH</PackageDescription>
<NDC11Code>37205-0363-74</NDC11Code>
<ProductNDC>37205-363</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Nicotine Transdermal System</ProprietaryName>
<ProprietaryNameSuffix>Step 3</ProprietaryNameSuffix>
<NonProprietaryName>Nicotine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120102</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020076</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>7</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50742-363-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (50742-363-60) </PackageDescription>
<NDC11Code>50742-0363-60</NDC11Code>
<ProductNDC>50742-363</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ivabradine</ProprietaryName>
<NonProprietaryName>Ivabradine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214051</ApplicationNumber>
<LabelerName>Ingenus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>IVABRADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: 1 To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. (1.1).</IndicationAndUsage>
<Description>Ivabradine tablets contains ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. The chemical name for ivabradine hydrochloride is. 3-(3-{[((7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl] methyl amino} propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one,hydrochloride.The molecular formula is C27 H36 N2O5· HCl, and the molecular weight (free base +HCl) is 505.1 (468.6 + 36.5). The chemical structure of ivabradine is shown in Figure 1. Figure 1. Chemical Structure of Ivabradine. Tablets. Ivabradine tablets are supplied in 5 mg and 7.5 mg tablets for oral administration. The tablets contain 5 mg and 7.5 mg of ivabradine, as active ingredient, equivalent to 5.39 mg and 8.09 mg of ivabradine hydrochloride, respectively. The tablets contain the following inactive ingredients: lactose monohydrate, maltodextrin, maize starch b, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol 4000, yellow iron oxide and red iron oxide.</Description>
</NDC>
</NDCList>