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"IndicationAndUsage": "INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with. - tardive dyskinesia [see Clinical Studies (14.1)]. - chorea associated with Huntington’s disease [see Clinical Studies (14.2)].",
"Description": "INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure. The molecular formula of valbenazine free base is C24H38N2O4 and its molecular weight is 418.57. INGREZZA is intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin. INGREZZA SPRINKLE is intended for oral administration. Each capsule contains granules consisting of 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The oral granules contain the following inactive ingredients: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc in hard gelatin capsules (contains gelatin and candurin silver fine)."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with. - tardive dyskinesia [see Clinical Studies (14.1)]. - chorea associated with Huntington’s disease [see Clinical Studies (14.2)].",
"Description": "INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure. The molecular formula of valbenazine free base is C24H38N2O4 and its molecular weight is 418.57. INGREZZA is intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin. INGREZZA SPRINKLE is intended for oral administration. Each capsule contains granules consisting of 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The oral granules contain the following inactive ingredients: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc in hard gelatin capsules (contains gelatin and candurin silver fine)."
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"IndicationAndUsage": "INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with. - tardive dyskinesia [see Clinical Studies (14.1)]. - chorea associated with Huntington’s disease [see Clinical Studies (14.2)].",
"Description": "INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure. The molecular formula of valbenazine free base is C24H38N2O4 and its molecular weight is 418.57. INGREZZA is intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin. INGREZZA SPRINKLE is intended for oral administration. Each capsule contains granules consisting of 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The oral granules contain the following inactive ingredients: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc in hard gelatin capsules (contains gelatin and candurin silver fine)."
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with. - tardive dyskinesia [see Clinical Studies (14.1)]. - chorea associated with Huntington’s disease [see Clinical Studies (14.2)].",
"Description": "INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure. The molecular formula of valbenazine free base is C24H38N2O4 and its molecular weight is 418.57. INGREZZA is intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin. INGREZZA SPRINKLE is intended for oral administration. Each capsule contains granules consisting of 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The oral granules contain the following inactive ingredients: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc in hard gelatin capsules (contains gelatin and candurin silver fine)."
},
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"PackageDescription": "1 BLISTER PACK in 1 CARTON (70370-2046-1) / 1 KIT in 1 BLISTER PACK",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with. - tardive dyskinesia [see Clinical Studies (14.1)]. - chorea associated with Huntington’s disease [see Clinical Studies (14.2)].",
"Description": "INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure. The molecular formula of valbenazine free base is C24H38N2O4 and its molecular weight is 418.57. INGREZZA is intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin. INGREZZA SPRINKLE is intended for oral administration. Each capsule contains granules consisting of 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The oral granules contain the following inactive ingredients: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc in hard gelatin capsules (contains gelatin and candurin silver fine)."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with. - tardive dyskinesia [see Clinical Studies (14.1)]. - chorea associated with Huntington’s disease [see Clinical Studies (14.2)].",
"Description": "INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure. The molecular formula of valbenazine free base is C24H38N2O4 and its molecular weight is 418.57. INGREZZA is intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin. INGREZZA SPRINKLE is intended for oral administration. Each capsule contains granules consisting of 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The oral granules contain the following inactive ingredients: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc in hard gelatin capsules (contains gelatin and candurin silver fine)."
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},
{
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"IndicationAndUsage": "ONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.",
"Description": "ONGENTYS contains opicapone, a peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor. The chemical name of opicapone is 2,5-dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide with the following structure:. The opicapone molecular formula is C15H10Cl2N4O6; and its molecular weight is 413.17. Opicapone is a yellow powder/crystalline solid with limited aqueous solubility. ONGENTYS capsules are intended for oral administration. Each capsule contains 25 mg or 50 mg of opicapone. ONGENTYS also contains the following inactive ingredients: lactose, magnesium stearate, pregelatinized starch, and sodium starch glycolate. The capsule shells contain: FD&C Blue#2, FD&C Red#3, gelatin, and titanium dioxide."
},
{
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"IndicationAndUsage": "ONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.",
"Description": "ONGENTYS contains opicapone, a peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor. The chemical name of opicapone is 2,5-dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide with the following structure:. The opicapone molecular formula is C15H10Cl2N4O6; and its molecular weight is 413.17. Opicapone is a yellow powder/crystalline solid with limited aqueous solubility. ONGENTYS capsules are intended for oral administration. Each capsule contains 25 mg or 50 mg of opicapone. ONGENTYS also contains the following inactive ingredients: lactose, magnesium stearate, pregelatinized starch, and sodium starch glycolate. The capsule shells contain: FD&C Blue#2, FD&C Red#3, gelatin, and titanium dioxide."
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"LabelerName": "Neurocrine Biosciences, Inc.",
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"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with. - tardive dyskinesia [see Clinical Studies (14.1)]. - chorea associated with Huntington’s disease [see Clinical Studies (14.2)].",
"Description": "INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure. The molecular formula of valbenazine free base is C24H38N2O4 and its molecular weight is 418.57. INGREZZA is intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin. INGREZZA SPRINKLE is intended for oral administration. Each capsule contains granules consisting of 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The oral granules contain the following inactive ingredients: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc in hard gelatin capsules (contains gelatin and candurin silver fine)."
},
{
"NDCCode": "70370-4080-1",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (70370-4080-1) ",
"NDC11Code": "70370-4080-01",
"ProductNDC": "70370-4080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ingrezza Sprinkle",
"NonProprietaryName": "Valbenazine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218390",
"LabelerName": "Neurocrine Biosciences, Inc.",
"SubstanceName": "VALBENAZINE TOSYLATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240430",
"SamplePackage": "N",
"IndicationAndUsage": "INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with. - tardive dyskinesia [see Clinical Studies (14.1)]. - chorea associated with Huntington’s disease [see Clinical Studies (14.2)].",
"Description": "INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure. The molecular formula of valbenazine free base is C24H38N2O4 and its molecular weight is 418.57. INGREZZA is intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin. INGREZZA SPRINKLE is intended for oral administration. Each capsule contains granules consisting of 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The oral granules contain the following inactive ingredients: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc in hard gelatin capsules (contains gelatin and candurin silver fine)."
},
{
"NDCCode": "70370-5025-1",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (70370-5025-1) ",
"NDC11Code": "70370-5025-01",
"ProductNDC": "70370-5025",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Crenessity",
"NonProprietaryName": "Crinecerfont",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218808",
"LabelerName": "Neurocrine Biosciences, Inc.",
"SubstanceName": "CRINECERFONT",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "CRENESSITY is indicated as adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).",
"Description": "CRENESSITY contains crinecerfont, a selective corticotropin-releasing factor type 1 receptor antagonist, present as crinecerfont free base, with the chemical name, 2-thiazolamine, 4-(2-chloro-4-methoxy-5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-N-2-propyn-1-yl. Crinecerfont free base is the S-enantiomer with an enantiomeric excess of at least 99.7%. Its molecular formula is C27H28ClFN2OS, and its molecular weight is 483.04 g/mol with the following structure. CRENESSITY Capsules. CRENESSITY capsules are intended for oral administration only. Each capsule contains 25 mg, 50 mg, or 100 mg of crinecerfont free base. Inactive ingredients include lauroyl polyoxyl-32 glycerides, medium chain triglycerides, propylene glycol dicaprylate/dicaprate, and Vitamin E polyethylene glycol succinate. The capsule shell contains gelatin, glycerin, red iron oxide, Sorbitol glycerin blend, titanium dioxide, and yellow iron oxide. CRENESSITY Oral Solution. The oral solution formulation contains 50 mg/mL of crinecerfont free base. Inactive ingredients include butylated hydroxytoluene, medium-chain triglycerides, oleoyl polyoxyl glycerides, orange flavor, and saccharin."
},
{
"NDCCode": "70370-5050-1",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (70370-5050-1) ",
"NDC11Code": "70370-5050-01",
"ProductNDC": "70370-5050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Crenessity",
"NonProprietaryName": "Crinecerfont",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218808",
"LabelerName": "Neurocrine Biosciences, Inc.",
"SubstanceName": "CRINECERFONT",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "CRENESSITY is indicated as adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).",
"Description": "CRENESSITY contains crinecerfont, a selective corticotropin-releasing factor type 1 receptor antagonist, present as crinecerfont free base, with the chemical name, 2-thiazolamine, 4-(2-chloro-4-methoxy-5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-N-2-propyn-1-yl. Crinecerfont free base is the S-enantiomer with an enantiomeric excess of at least 99.7%. Its molecular formula is C27H28ClFN2OS, and its molecular weight is 483.04 g/mol with the following structure. CRENESSITY Capsules. CRENESSITY capsules are intended for oral administration only. Each capsule contains 25 mg, 50 mg, or 100 mg of crinecerfont free base. Inactive ingredients include lauroyl polyoxyl-32 glycerides, medium chain triglycerides, propylene glycol dicaprylate/dicaprate, and Vitamin E polyethylene glycol succinate. The capsule shell contains gelatin, glycerin, red iron oxide, Sorbitol glycerin blend, titanium dioxide, and yellow iron oxide. CRENESSITY Oral Solution. The oral solution formulation contains 50 mg/mL of crinecerfont free base. Inactive ingredients include butylated hydroxytoluene, medium-chain triglycerides, oleoyl polyoxyl glycerides, orange flavor, and saccharin."
},
{
"NDCCode": "70370-5100-1",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (70370-5100-1) ",
"NDC11Code": "70370-5100-01",
"ProductNDC": "70370-5100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Crenessity",
"NonProprietaryName": "Crinecerfont",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218808",
"LabelerName": "Neurocrine Biosciences, Inc.",
"SubstanceName": "CRINECERFONT",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "CRENESSITY is indicated as adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).",
"Description": "CRENESSITY contains crinecerfont, a selective corticotropin-releasing factor type 1 receptor antagonist, present as crinecerfont free base, with the chemical name, 2-thiazolamine, 4-(2-chloro-4-methoxy-5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-N-2-propyn-1-yl. Crinecerfont free base is the S-enantiomer with an enantiomeric excess of at least 99.7%. Its molecular formula is C27H28ClFN2OS, and its molecular weight is 483.04 g/mol with the following structure. CRENESSITY Capsules. CRENESSITY capsules are intended for oral administration only. Each capsule contains 25 mg, 50 mg, or 100 mg of crinecerfont free base. Inactive ingredients include lauroyl polyoxyl-32 glycerides, medium chain triglycerides, propylene glycol dicaprylate/dicaprate, and Vitamin E polyethylene glycol succinate. The capsule shell contains gelatin, glycerin, red iron oxide, Sorbitol glycerin blend, titanium dioxide, and yellow iron oxide. CRENESSITY Oral Solution. The oral solution formulation contains 50 mg/mL of crinecerfont free base. Inactive ingredients include butylated hydroxytoluene, medium-chain triglycerides, oleoyl polyoxyl glycerides, orange flavor, and saccharin."
},
{
"NDCCode": "70370-5250-1",
"PackageDescription": "30 mL in 1 BOTTLE (70370-5250-1) ",
"NDC11Code": "70370-5250-01",
"ProductNDC": "70370-5250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Crenessity",
"NonProprietaryName": "Crinecerfont",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218820",
"LabelerName": "Neurocrine Biosciences, Inc.",
"SubstanceName": "CRINECERFONT",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "CRENESSITY is indicated as adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).",
"Description": "CRENESSITY contains crinecerfont, a selective corticotropin-releasing factor type 1 receptor antagonist, present as crinecerfont free base, with the chemical name, 2-thiazolamine, 4-(2-chloro-4-methoxy-5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-N-2-propyn-1-yl. Crinecerfont free base is the S-enantiomer with an enantiomeric excess of at least 99.7%. Its molecular formula is C27H28ClFN2OS, and its molecular weight is 483.04 g/mol with the following structure. CRENESSITY Capsules. CRENESSITY capsules are intended for oral administration only. Each capsule contains 25 mg, 50 mg, or 100 mg of crinecerfont free base. Inactive ingredients include lauroyl polyoxyl-32 glycerides, medium chain triglycerides, propylene glycol dicaprylate/dicaprate, and Vitamin E polyethylene glycol succinate. The capsule shell contains gelatin, glycerin, red iron oxide, Sorbitol glycerin blend, titanium dioxide, and yellow iron oxide. CRENESSITY Oral Solution. The oral solution formulation contains 50 mg/mL of crinecerfont free base. Inactive ingredients include butylated hydroxytoluene, medium-chain triglycerides, oleoyl polyoxyl glycerides, orange flavor, and saccharin."
},
{
"NDCCode": "0003-4040-12",
"PackageDescription": "120 CAPSULE in 1 BOTTLE (0003-4040-12) ",
"NDC11Code": "00003-4040-12",
"ProductNDC": "0003-4040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Augtyro",
"NonProprietaryName": "Repotrectinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20231205",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218213",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "REPOTRECTINIB",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inducers [MoA], Kinase Inhibitor [EPC], Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors [MoA], Tropomyosin Receptor Tyrosine Kinase A Inhibitors [MoA], Tropomyosin Receptor Tyrosine Kinase B Inhibitors [MoA], Tropomyosin Receptor Tyrosine Kinase C Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231205",
"SamplePackage": "N",
"IndicationAndUsage": "AUGTYRO is a kinase inhibitor indicated for the treatment of : 1 adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). (1.1), 2 adult and pediatric patients 12 years of age and older with solid tumors that:, 3 have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion and, 4 are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity., 5 have progressed following treatment or have no satisfactory alternative therapy.",
"Description": "Repotrectinib is a kinase inhibitor. The molecular formula for repotrectinib is C18H18FN5O2 and the molecular weight is 355.37 Daltons. The chemical name is (3R,11S)-6-Fluoro-3,11-dimethyl-10-oxa-2,13,17,18,21-pentaazatetracyclo[13.5.2.04,9.018,22]docosa-1(21),4,6,8,15(22),16,19-heptaen-14-one. The chemical structure of repotrectinib is as follows. Repotrectinib is a white to off-white powder. AUGTYRO (repotrectinib) capsules for oral use are supplied as printed hard shell capsules containing 40 mg of repotrectinib. Inactive ingredients are microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, and colloidal silicon dioxide. The white opaque capsule shell contains gelatin and titanium dioxide. The printing ink contains shellac and FD & C blue #2 aluminum lake. AUGTYRO (repotrectinib) capsules for oral use are supplied as printed hard shell capsules containing 160 mg of repotrectinib. Inactive ingredients are microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, magnesium stearate, and colloidal silicon dioxide. The blue opaque capsule shell contains gelatin, titanium dioxide and FD & C blue #1. The printing ink contains shellac and titanium dioxide."
},
{
"NDCCode": "0003-4040-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (0003-4040-60) ",
"NDC11Code": "00003-4040-60",
"ProductNDC": "0003-4040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Augtyro",
"NonProprietaryName": "Repotrectinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20231205",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218213",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "REPOTRECTINIB",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inducers [MoA], Kinase Inhibitor [EPC], Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors [MoA], Tropomyosin Receptor Tyrosine Kinase A Inhibitors [MoA], Tropomyosin Receptor Tyrosine Kinase B Inhibitors [MoA], Tropomyosin Receptor Tyrosine Kinase C Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231205",
"SamplePackage": "N",
"IndicationAndUsage": "AUGTYRO is a kinase inhibitor indicated for the treatment of : 1 adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). (1.1), 2 adult and pediatric patients 12 years of age and older with solid tumors that:, 3 have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion and, 4 are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity., 5 have progressed following treatment or have no satisfactory alternative therapy.",
"Description": "Repotrectinib is a kinase inhibitor. The molecular formula for repotrectinib is C18H18FN5O2 and the molecular weight is 355.37 Daltons. The chemical name is (3R,11S)-6-Fluoro-3,11-dimethyl-10-oxa-2,13,17,18,21-pentaazatetracyclo[13.5.2.04,9.018,22]docosa-1(21),4,6,8,15(22),16,19-heptaen-14-one. The chemical structure of repotrectinib is as follows. Repotrectinib is a white to off-white powder. AUGTYRO (repotrectinib) capsules for oral use are supplied as printed hard shell capsules containing 40 mg of repotrectinib. Inactive ingredients are microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, and colloidal silicon dioxide. The white opaque capsule shell contains gelatin and titanium dioxide. The printing ink contains shellac and FD & C blue #2 aluminum lake. AUGTYRO (repotrectinib) capsules for oral use are supplied as printed hard shell capsules containing 160 mg of repotrectinib. Inactive ingredients are microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, magnesium stearate, and colloidal silicon dioxide. The blue opaque capsule shell contains gelatin, titanium dioxide and FD & C blue #1. The printing ink contains shellac and titanium dioxide."
},
{
"NDCCode": "0186-4040-01",
"PackageDescription": "30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4040-01) ",
"NDC11Code": "00186-4040-01",
"ProductNDC": "0186-4040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nexium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "GRANULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070319",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021957",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070319",
"SamplePackage": "N",
"IndicationAndUsage": "NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral. suspension are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).",
"Description": "The active ingredient in NEXIUM® (esomeprazole magnesium) delayed-release capsules for oral administration and NEXIUM (esomeprazole magnesium) for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each NEXIUM delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: D&C Red #28, D&C Yellow #10, ethyl alcohol, FD&C Blue #1, FD&C Red #40, gelatin, isopropyl alcohol, n-butyl alcohol, polyvinyl pyrrolidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. Each packet of NEXIUM for delayed-release oral suspension contains esomeprazole, in the form of same enteric-coated granules used in NEXIUM delayed-release capsules, and also inactive granules: 1 2.5 mg esomeprazole (equivalent to 2.8 mg esomeprazole magnesium trihydrate), 2 5 mg esomeprazole (equivalent to 5.6 mg esomeprazole magnesium trihydrate), 3 10 mg esomeprazole (equivalent to 11.1 mg esomeprazole magnesium trihydrate), 4 20 mg esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate), 5 40 mg esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate)."
},
{
"NDCCode": "0186-4040-02",
"PackageDescription": "5 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4040-02) ",
"NDC11Code": "00186-4040-02",
"ProductNDC": "0186-4040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nexium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "GRANULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20070319",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021957",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20070319",
"SamplePackage": "Y"
},
{
"NDCCode": "0220-4040-41",
"PackageDescription": "200 [kp_C] in 1 TUBE (0220-4040-41) ",
"NDC11Code": "00220-4040-41",
"ProductNDC": "0220-4040",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Phosphorus",
"NonProprietaryName": "Phosphorus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "PHOSPHORUS",
"StrengthNumber": "200",
"StrengthUnit": "[kp_C]/200[kp_C]",
"Status": "Active",
"LastUpdate": "2023-01-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830303",
"SamplePackage": "N",
"IndicationAndUsage": "Dizziness With Sleeplessness*."
},
{
"NDCCode": "0363-4040-21",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0363-4040-21) / 8 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "00363-4040-21",
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<Description>INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure. The molecular formula of valbenazine free base is C24H38N2O4 and its molecular weight is 418.57. INGREZZA is intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin. INGREZZA SPRINKLE is intended for oral administration. Each capsule contains granules consisting of 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The oral granules contain the following inactive ingredients: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc in hard gelatin capsules (contains gelatin and candurin silver fine).</Description>
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<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with. - tardive dyskinesia [see Clinical Studies (14.1)]. - chorea associated with Huntington’s disease [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure. The molecular formula of valbenazine free base is C24H38N2O4 and its molecular weight is 418.57. INGREZZA is intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin. INGREZZA SPRINKLE is intended for oral administration. Each capsule contains granules consisting of 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The oral granules contain the following inactive ingredients: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc in hard gelatin capsules (contains gelatin and candurin silver fine).</Description>
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<StartMarketingDate>20230818</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209241</ApplicationNumber>
<LabelerName>Neurocrine Biosciences, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230818</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with. - tardive dyskinesia [see Clinical Studies (14.1)]. - chorea associated with Huntington’s disease [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure. The molecular formula of valbenazine free base is C24H38N2O4 and its molecular weight is 418.57. INGREZZA is intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin. INGREZZA SPRINKLE is intended for oral administration. Each capsule contains granules consisting of 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The oral granules contain the following inactive ingredients: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc in hard gelatin capsules (contains gelatin and candurin silver fine).</Description>
</NDC>
<NDC>
<NDCCode>70370-2048-6</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (70370-2048-6) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70370-2048-06</NDC11Code>
<ProductNDC>70370-2048</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ingrezza</ProprietaryName>
<NonProprietaryName>Valbenazine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209241</ApplicationNumber>
<LabelerName>Neurocrine Biosciences, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with. - tardive dyskinesia [see Clinical Studies (14.1)]. - chorea associated with Huntington’s disease [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure. The molecular formula of valbenazine free base is C24H38N2O4 and its molecular weight is 418.57. INGREZZA is intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin. INGREZZA SPRINKLE is intended for oral administration. Each capsule contains granules consisting of 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The oral granules contain the following inactive ingredients: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc in hard gelatin capsules (contains gelatin and candurin silver fine).</Description>
</NDC>
<NDC>
<NDCCode>70370-3025-2</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (70370-3025-2) </PackageDescription>
<NDC11Code>70370-3025-02</NDC11Code>
<ProductNDC>70370-3025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ongentys</ProprietaryName>
<NonProprietaryName>Opicapone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200424</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212489</ApplicationNumber>
<LabelerName>Neurocrine Biosciences, Inc.</LabelerName>
<SubstanceName>OPICAPONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.</IndicationAndUsage>
<Description>ONGENTYS contains opicapone, a peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor. The chemical name of opicapone is 2,5-dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide with the following structure:. The opicapone molecular formula is C15H10Cl2N4O6; and its molecular weight is 413.17. Opicapone is a yellow powder/crystalline solid with limited aqueous solubility. ONGENTYS capsules are intended for oral administration. Each capsule contains 25 mg or 50 mg of opicapone. ONGENTYS also contains the following inactive ingredients: lactose, magnesium stearate, pregelatinized starch, and sodium starch glycolate. The capsule shells contain: FD&C Blue#2, FD&C Red#3, gelatin, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70370-3050-2</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (70370-3050-2) </PackageDescription>
<NDC11Code>70370-3050-02</NDC11Code>
<ProductNDC>70370-3050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<LabelerName>Neurocrine Biosciences, Inc.</LabelerName>
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<Pharm_Classes>Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.</IndicationAndUsage>
<Description>ONGENTYS contains opicapone, a peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor. The chemical name of opicapone is 2,5-dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide with the following structure:. The opicapone molecular formula is C15H10Cl2N4O6; and its molecular weight is 413.17. Opicapone is a yellow powder/crystalline solid with limited aqueous solubility. ONGENTYS capsules are intended for oral administration. Each capsule contains 25 mg or 50 mg of opicapone. ONGENTYS also contains the following inactive ingredients: lactose, magnesium stearate, pregelatinized starch, and sodium starch glycolate. The capsule shells contain: FD&C Blue#2, FD&C Red#3, gelatin, and titanium dioxide.</Description>
</NDC>
<NDC>
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<PackageDescription>7 CAPSULE in 1 BOTTLE (70370-3050-5) </PackageDescription>
<NDC11Code>70370-3050-05</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ongentys</ProprietaryName>
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<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200424</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212489</ApplicationNumber>
<LabelerName>Neurocrine Biosciences, Inc.</LabelerName>
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<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201026</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.</IndicationAndUsage>
<Description>ONGENTYS contains opicapone, a peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor. The chemical name of opicapone is 2,5-dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide with the following structure:. The opicapone molecular formula is C15H10Cl2N4O6; and its molecular weight is 413.17. Opicapone is a yellow powder/crystalline solid with limited aqueous solubility. ONGENTYS capsules are intended for oral administration. Each capsule contains 25 mg or 50 mg of opicapone. ONGENTYS also contains the following inactive ingredients: lactose, magnesium stearate, pregelatinized starch, and sodium starch glycolate. The capsule shells contain: FD&C Blue#2, FD&C Red#3, gelatin, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70370-4060-1</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (70370-4060-1) </PackageDescription>
<NDC11Code>70370-4060-01</NDC11Code>
<ProductNDC>70370-4060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ingrezza Sprinkle</ProprietaryName>
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<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218390</ApplicationNumber>
<LabelerName>Neurocrine Biosciences, Inc.</LabelerName>
<SubstanceName>VALBENAZINE TOSYLATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with. - tardive dyskinesia [see Clinical Studies (14.1)]. - chorea associated with Huntington’s disease [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure. The molecular formula of valbenazine free base is C24H38N2O4 and its molecular weight is 418.57. INGREZZA is intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin. INGREZZA SPRINKLE is intended for oral administration. Each capsule contains granules consisting of 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The oral granules contain the following inactive ingredients: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc in hard gelatin capsules (contains gelatin and candurin silver fine).</Description>
</NDC>
<NDC>
<NDCCode>70370-4080-1</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (70370-4080-1) </PackageDescription>
<NDC11Code>70370-4080-01</NDC11Code>
<ProductNDC>70370-4080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ingrezza Sprinkle</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20240430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218390</ApplicationNumber>
<LabelerName>Neurocrine Biosciences, Inc.</LabelerName>
<SubstanceName>VALBENAZINE TOSYLATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with. - tardive dyskinesia [see Clinical Studies (14.1)]. - chorea associated with Huntington’s disease [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>INGREZZA and INGREZZA SPRINKLE contains valbenazine, a vesicular monoamine transporter 2 (VMAT2) inhibitor, present as valbenazine tosylate salt, with the chemical name, L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester, 4-methylbenzenesulfonate (1:2). Valbenazine tosylate is slightly soluble in water. Its molecular formula is C38H54N2O10S2, and its molecular weight is 762.97 g/mol (ditosylate salt) with the following structure. The molecular formula of valbenazine free base is C24H38N2O4 and its molecular weight is 418.57. INGREZZA is intended for oral administration only. Each capsule contains 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The capsules contain the following inactive ingredients: hypromellose, isomalt, magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. The capsule shells contain candurin silver fine, FD&C Blue#1, FD&C Red#40, and gelatin. INGREZZA SPRINKLE is intended for oral administration. Each capsule contains granules consisting of 73 mg, 109 mg or 146 mg of valbenazine tosylate equivalent to 40 mg, 60 mg or 80 mg of valbenazine free base, respectively. The oral granules contain the following inactive ingredients: silicified microcrystalline cellulose, isomalt, pregelatinized maize starch, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc in hard gelatin capsules (contains gelatin and candurin silver fine).</Description>
</NDC>
<NDC>
<NDCCode>70370-5025-1</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (70370-5025-1) </PackageDescription>
<NDC11Code>70370-5025-01</NDC11Code>
<ProductNDC>70370-5025</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Crenessity</ProprietaryName>
<NonProprietaryName>Crinecerfont</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218808</ApplicationNumber>
<LabelerName>Neurocrine Biosciences, Inc.</LabelerName>
<SubstanceName>CRINECERFONT</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CRENESSITY is indicated as adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).</IndicationAndUsage>
<Description>CRENESSITY contains crinecerfont, a selective corticotropin-releasing factor type 1 receptor antagonist, present as crinecerfont free base, with the chemical name, 2-thiazolamine, 4-(2-chloro-4-methoxy-5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-N-2-propyn-1-yl. Crinecerfont free base is the S-enantiomer with an enantiomeric excess of at least 99.7%. Its molecular formula is C27H28ClFN2OS, and its molecular weight is 483.04 g/mol with the following structure. CRENESSITY Capsules. CRENESSITY capsules are intended for oral administration only. Each capsule contains 25 mg, 50 mg, or 100 mg of crinecerfont free base. Inactive ingredients include lauroyl polyoxyl-32 glycerides, medium chain triglycerides, propylene glycol dicaprylate/dicaprate, and Vitamin E polyethylene glycol succinate. The capsule shell contains gelatin, glycerin, red iron oxide, Sorbitol glycerin blend, titanium dioxide, and yellow iron oxide. CRENESSITY Oral Solution. The oral solution formulation contains 50 mg/mL of crinecerfont free base. Inactive ingredients include butylated hydroxytoluene, medium-chain triglycerides, oleoyl polyoxyl glycerides, orange flavor, and saccharin.</Description>
</NDC>
<NDC>
<NDCCode>70370-5050-1</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (70370-5050-1) </PackageDescription>
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<ProductNDC>70370-5050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Crenessity</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218808</ApplicationNumber>
<LabelerName>Neurocrine Biosciences, Inc.</LabelerName>
<SubstanceName>CRINECERFONT</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CRENESSITY is indicated as adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).</IndicationAndUsage>
<Description>CRENESSITY contains crinecerfont, a selective corticotropin-releasing factor type 1 receptor antagonist, present as crinecerfont free base, with the chemical name, 2-thiazolamine, 4-(2-chloro-4-methoxy-5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-N-2-propyn-1-yl. Crinecerfont free base is the S-enantiomer with an enantiomeric excess of at least 99.7%. Its molecular formula is C27H28ClFN2OS, and its molecular weight is 483.04 g/mol with the following structure. CRENESSITY Capsules. CRENESSITY capsules are intended for oral administration only. Each capsule contains 25 mg, 50 mg, or 100 mg of crinecerfont free base. Inactive ingredients include lauroyl polyoxyl-32 glycerides, medium chain triglycerides, propylene glycol dicaprylate/dicaprate, and Vitamin E polyethylene glycol succinate. The capsule shell contains gelatin, glycerin, red iron oxide, Sorbitol glycerin blend, titanium dioxide, and yellow iron oxide. CRENESSITY Oral Solution. The oral solution formulation contains 50 mg/mL of crinecerfont free base. Inactive ingredients include butylated hydroxytoluene, medium-chain triglycerides, oleoyl polyoxyl glycerides, orange flavor, and saccharin.</Description>
</NDC>
<NDC>
<NDCCode>70370-5100-1</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (70370-5100-1) </PackageDescription>
<NDC11Code>70370-5100-01</NDC11Code>
<ProductNDC>70370-5100</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Crenessity</ProprietaryName>
<NonProprietaryName>Crinecerfont</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218808</ApplicationNumber>
<LabelerName>Neurocrine Biosciences, Inc.</LabelerName>
<SubstanceName>CRINECERFONT</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CRENESSITY is indicated as adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).</IndicationAndUsage>
<Description>CRENESSITY contains crinecerfont, a selective corticotropin-releasing factor type 1 receptor antagonist, present as crinecerfont free base, with the chemical name, 2-thiazolamine, 4-(2-chloro-4-methoxy-5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-N-2-propyn-1-yl. Crinecerfont free base is the S-enantiomer with an enantiomeric excess of at least 99.7%. Its molecular formula is C27H28ClFN2OS, and its molecular weight is 483.04 g/mol with the following structure. CRENESSITY Capsules. CRENESSITY capsules are intended for oral administration only. Each capsule contains 25 mg, 50 mg, or 100 mg of crinecerfont free base. Inactive ingredients include lauroyl polyoxyl-32 glycerides, medium chain triglycerides, propylene glycol dicaprylate/dicaprate, and Vitamin E polyethylene glycol succinate. The capsule shell contains gelatin, glycerin, red iron oxide, Sorbitol glycerin blend, titanium dioxide, and yellow iron oxide. CRENESSITY Oral Solution. The oral solution formulation contains 50 mg/mL of crinecerfont free base. Inactive ingredients include butylated hydroxytoluene, medium-chain triglycerides, oleoyl polyoxyl glycerides, orange flavor, and saccharin.</Description>
</NDC>
<NDC>
<NDCCode>70370-5250-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (70370-5250-1) </PackageDescription>
<NDC11Code>70370-5250-01</NDC11Code>
<ProductNDC>70370-5250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Crenessity</ProprietaryName>
<NonProprietaryName>Crinecerfont</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218820</ApplicationNumber>
<LabelerName>Neurocrine Biosciences, Inc.</LabelerName>
<SubstanceName>CRINECERFONT</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CRENESSITY is indicated as adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).</IndicationAndUsage>
<Description>CRENESSITY contains crinecerfont, a selective corticotropin-releasing factor type 1 receptor antagonist, present as crinecerfont free base, with the chemical name, 2-thiazolamine, 4-(2-chloro-4-methoxy-5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-N-2-propyn-1-yl. Crinecerfont free base is the S-enantiomer with an enantiomeric excess of at least 99.7%. Its molecular formula is C27H28ClFN2OS, and its molecular weight is 483.04 g/mol with the following structure. CRENESSITY Capsules. CRENESSITY capsules are intended for oral administration only. Each capsule contains 25 mg, 50 mg, or 100 mg of crinecerfont free base. Inactive ingredients include lauroyl polyoxyl-32 glycerides, medium chain triglycerides, propylene glycol dicaprylate/dicaprate, and Vitamin E polyethylene glycol succinate. The capsule shell contains gelatin, glycerin, red iron oxide, Sorbitol glycerin blend, titanium dioxide, and yellow iron oxide. CRENESSITY Oral Solution. The oral solution formulation contains 50 mg/mL of crinecerfont free base. Inactive ingredients include butylated hydroxytoluene, medium-chain triglycerides, oleoyl polyoxyl glycerides, orange flavor, and saccharin.</Description>
</NDC>
<NDC>
<NDCCode>0003-4040-12</NDCCode>
<PackageDescription>120 CAPSULE in 1 BOTTLE (0003-4040-12) </PackageDescription>
<NDC11Code>00003-4040-12</NDC11Code>
<ProductNDC>0003-4040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Augtyro</ProprietaryName>
<NonProprietaryName>Repotrectinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231205</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218213</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>REPOTRECTINIB</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inducers [MoA], Kinase Inhibitor [EPC], Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors [MoA], Tropomyosin Receptor Tyrosine Kinase A Inhibitors [MoA], Tropomyosin Receptor Tyrosine Kinase B Inhibitors [MoA], Tropomyosin Receptor Tyrosine Kinase C Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AUGTYRO is a kinase inhibitor indicated for the treatment of : 1 adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). (1.1), 2 adult and pediatric patients 12 years of age and older with solid tumors that:, 3 have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion and, 4 are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity., 5 have progressed following treatment or have no satisfactory alternative therapy.</IndicationAndUsage>
<Description>Repotrectinib is a kinase inhibitor. The molecular formula for repotrectinib is C18H18FN5O2 and the molecular weight is 355.37 Daltons. The chemical name is (3R,11S)-6-Fluoro-3,11-dimethyl-10-oxa-2,13,17,18,21-pentaazatetracyclo[13.5.2.04,9.018,22]docosa-1(21),4,6,8,15(22),16,19-heptaen-14-one. The chemical structure of repotrectinib is as follows. Repotrectinib is a white to off-white powder. AUGTYRO (repotrectinib) capsules for oral use are supplied as printed hard shell capsules containing 40 mg of repotrectinib. Inactive ingredients are microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, and colloidal silicon dioxide. The white opaque capsule shell contains gelatin and titanium dioxide. The printing ink contains shellac and FD & C blue #2 aluminum lake. AUGTYRO (repotrectinib) capsules for oral use are supplied as printed hard shell capsules containing 160 mg of repotrectinib. Inactive ingredients are microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, magnesium stearate, and colloidal silicon dioxide. The blue opaque capsule shell contains gelatin, titanium dioxide and FD & C blue #1. The printing ink contains shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0003-4040-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (0003-4040-60) </PackageDescription>
<NDC11Code>00003-4040-60</NDC11Code>
<ProductNDC>0003-4040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Augtyro</ProprietaryName>
<NonProprietaryName>Repotrectinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231205</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218213</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>REPOTRECTINIB</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inducers [MoA], Kinase Inhibitor [EPC], Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors [MoA], Tropomyosin Receptor Tyrosine Kinase A Inhibitors [MoA], Tropomyosin Receptor Tyrosine Kinase B Inhibitors [MoA], Tropomyosin Receptor Tyrosine Kinase C Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AUGTYRO is a kinase inhibitor indicated for the treatment of : 1 adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). (1.1), 2 adult and pediatric patients 12 years of age and older with solid tumors that:, 3 have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion and, 4 are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity., 5 have progressed following treatment or have no satisfactory alternative therapy.</IndicationAndUsage>
<Description>Repotrectinib is a kinase inhibitor. The molecular formula for repotrectinib is C18H18FN5O2 and the molecular weight is 355.37 Daltons. The chemical name is (3R,11S)-6-Fluoro-3,11-dimethyl-10-oxa-2,13,17,18,21-pentaazatetracyclo[13.5.2.04,9.018,22]docosa-1(21),4,6,8,15(22),16,19-heptaen-14-one. The chemical structure of repotrectinib is as follows. Repotrectinib is a white to off-white powder. AUGTYRO (repotrectinib) capsules for oral use are supplied as printed hard shell capsules containing 40 mg of repotrectinib. Inactive ingredients are microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, and colloidal silicon dioxide. The white opaque capsule shell contains gelatin and titanium dioxide. The printing ink contains shellac and FD & C blue #2 aluminum lake. AUGTYRO (repotrectinib) capsules for oral use are supplied as printed hard shell capsules containing 160 mg of repotrectinib. Inactive ingredients are microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, magnesium stearate, and colloidal silicon dioxide. The blue opaque capsule shell contains gelatin, titanium dioxide and FD & C blue #1. The printing ink contains shellac and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0186-4040-01</NDCCode>
<PackageDescription>30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4040-01) </PackageDescription>
<NDC11Code>00186-4040-01</NDC11Code>
<ProductNDC>0186-4040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nexium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>GRANULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070319</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021957</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral. suspension are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in NEXIUM® (esomeprazole magnesium) delayed-release capsules for oral administration and NEXIUM (esomeprazole magnesium) for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each NEXIUM delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: D&C Red #28, D&C Yellow #10, ethyl alcohol, FD&C Blue #1, FD&C Red #40, gelatin, isopropyl alcohol, n-butyl alcohol, polyvinyl pyrrolidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. Each packet of NEXIUM for delayed-release oral suspension contains esomeprazole, in the form of same enteric-coated granules used in NEXIUM delayed-release capsules, and also inactive granules: 1 2.5 mg esomeprazole (equivalent to 2.8 mg esomeprazole magnesium trihydrate), 2 5 mg esomeprazole (equivalent to 5.6 mg esomeprazole magnesium trihydrate), 3 10 mg esomeprazole (equivalent to 11.1 mg esomeprazole magnesium trihydrate), 4 20 mg esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate), 5 40 mg esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate).</Description>
</NDC>
<NDC>
<NDCCode>0186-4040-02</NDCCode>
<PackageDescription>5 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4040-02) </PackageDescription>
<NDC11Code>00186-4040-02</NDC11Code>
<ProductNDC>0186-4040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nexium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>GRANULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070319</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021957</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070319</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>0220-4040-41</NDCCode>
<PackageDescription>200 [kp_C] in 1 TUBE (0220-4040-41) </PackageDescription>
<NDC11Code>00220-4040-41</NDC11Code>
<ProductNDC>0220-4040</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Phosphorus</ProprietaryName>
<NonProprietaryName>Phosphorus</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>PHOSPHORUS</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[kp_C]/200[kp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dizziness With Sleeplessness*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0363-4040-21</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (0363-4040-21) / 8 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00363-4040-21</NDC11Code>
<ProductNDC>0363-4040</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Motion Sickness Relief</ProprietaryName>
<NonProprietaryName>Meclizine Hcl</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240531</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M009</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0456-4040-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0456-4040-01) </PackageDescription>
<NDC11Code>00456-4040-01</NDC11Code>
<ProductNDC>0456-4040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celexa</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980717</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020822</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CELEXA is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>CELEXA contains citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram hydrobromide occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. CELEXA tablets are for oral administration and are available as film-coated oval tablets. The strengths reflect citalopram base equivalent content. The 10 mg, 20 mg, and 40 mg strength tablets contain 12.49 mg, 24.98 mg, and 49.96 mg of citalopram hydrobromide, respectively. The 20 mg and 40 mg tablets are scored. Inactive ingredients: copolyvidone, corn starch, crosscarmellose sodium, glycerin, lactose monohydrate, magnesium stearate, hypromellose, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Iron oxides are used as coloring agents in the beige (10 mg) and pink (20 mg) tablets.</Description>
</NDC>
<NDC>
<NDCCode>0456-4040-63</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX, UNIT-DOSE (0456-4040-63) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0456-4040-11) </PackageDescription>
<NDC11Code>00456-4040-63</NDC11Code>
<ProductNDC>0456-4040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celexa</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980717</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020822</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0498-4040-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0498-4040-01) * 30 mL in 1 BOTTLE (0498-0100-01) </PackageDescription>
<NDC11Code>00498-4040-01</NDC11Code>
<ProductNDC>0498-4040</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>4040 First Aid Kit</ProprietaryName>
<NonProprietaryName>4040 First Aid Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20181018</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Honeywell Safety Products USA, INC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-4040-67</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKAGE, COMBINATION (0781-4040-67) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00781-4040-67</NDC11Code>
<ProductNDC>0781-4040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20100105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078645</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0904-4040-73</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0904-4040-73) / 36 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
<NDC11Code>00904-4040-73</NDC11Code>
<ProductNDC>0904-4040</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071212</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of minor aches and pains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-4040-1</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (11822-4040-1) / 8 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11822-4040-01</NDC11Code>
<ProductNDC>11822-4040</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Motion Sickness Relief</ProprietaryName>
<NonProprietaryName>Meclizine Hcl</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231110</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M009</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.</IndicationAndUsage>
</NDC>
</NDCList>