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"ProductTypeName": "HUMAN OTC DRUG",
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"PackageNdcExcludeFlag": "N",
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"ProductTypeName": "HUMAN OTC DRUG",
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"ProductTypeName": "HUMAN OTC DRUG",
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"IndicationAndUsage": "■ To help reduce germs and bacteria on the skin. ■ Recommended for repeated use. ■ No rinsing required."
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zep Instant Hand Sanitizer Gel",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Zep Inc.",
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"Status": "Active",
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"IndicationAndUsage": "■ To help reduce germs and bacteria on the skin. ■ Recommended for repeated use. ■ No rinsing required."
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"ProductNDC": "66949-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zep Alcohol Sanitizer",
"NonProprietaryName": "Ethanol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20000807",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
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"SubstanceName": "ALCOHOL",
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"PackageNdcExcludeFlag": "N",
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"ProductNDC": "66949-121",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zep Alcohol Sanitizer",
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"EndMarketingDate": "20211231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zep Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "73",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20000807",
"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "66949-133-89",
"PackageDescription": "1040988 mL in 1 CONTAINER (66949-133-89) ",
"NDC11Code": "66949-0133-89",
"ProductNDC": "66949-133",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zep Alcohol Sanitizer",
"NonProprietaryName": "Ethanol",
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"RouteName": "TOPICAL",
"StartMarketingDate": "20000807",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zep Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
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"LastUpdate": "2022-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20000807",
"SamplePackage": "N"
},
{
"NDCCode": "66949-878-89",
"PackageDescription": "1040988 mL in 1 CONTAINER (66949-878-89) ",
"NDC11Code": "66949-0878-89",
"ProductNDC": "66949-878",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zep Instant Hand Sanitizer",
"NonProprietaryName": "Ethanol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20040129",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zep Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "60",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20040129",
"EndMarketingDatePackage": "20221231",
"SamplePackage": "N"
},
{
"NDCCode": "66949-900-89",
"PackageDescription": "1040988 mL in 1 CONTAINER (66949-900-89) ",
"NDC11Code": "66949-0900-89",
"ProductNDC": "66949-900",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zep Alcohol Sanitizer",
"NonProprietaryName": "Ethanol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20000807",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zep Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20000807",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "66949-999-89",
"PackageDescription": "1040990 mL in 1 CONTAINER (66949-999-89)",
"NDC11Code": "66949-0999-89",
"ProductNDC": "66949-999",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zep Acclaim",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "19950329",
"EndMarketingDate": "20190101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zep Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".01",
"StrengthUnit": "g/10mL",
"Status": "Deprecated",
"LastUpdate": "2019-01-02",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "50458-560-01",
"PackageDescription": "1 SYRINGE in 1 KIT (50458-560-01) / .25 mL in 1 SYRINGE",
"NDC11Code": "50458-0560-01",
"ProductNDC": "50458-560",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invega Sustenna",
"NonProprietaryName": "Paliperidone Palmitate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20090731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022264",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "PALIPERIDONE PALMITATE",
"StrengthNumber": "39",
"StrengthUnit": "mg/.25mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090731",
"SamplePackage": "N",
"IndicationAndUsage": "INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: 1 Schizophrenia in adults [see Clinical Studies (14.1)]. , 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2)]. .",
"Description": "INVEGA SUSTENNA ® contains paliperidone palmitate. The active ingredient, paliperidone, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA SUSTENNA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4 and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate. INVEGA SUSTENNA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (and deliverable volumes) of the single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1.0 mL), and 234 mg (1.5 mL). The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive ingredients are polysorbate 20 (12 mg/mL), polyethylene glycol 4000 (30 mg/mL), citric acid monohydrate (5 mg/mL), disodium hydrogen phosphate anhydrous (5 mg/mL), sodium dihydrogen phosphate monohydrate (2.5 mg/mL), sodium hydroxide (2.84 mg/mL used as an alkalizing agent to set pH at 7), and water for injection. INVEGA SUSTENNA is provided in a single-dose prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains 2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety needle)."
},
{
"NDCCode": "50458-561-01",
"PackageDescription": "1 SYRINGE in 1 KIT (50458-561-01) / .5 mL in 1 SYRINGE",
"NDC11Code": "50458-0561-01",
"ProductNDC": "50458-561",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invega Sustenna",
"NonProprietaryName": "Paliperidone Palmitate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20090731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022264",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "PALIPERIDONE PALMITATE",
"StrengthNumber": "78",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090731",
"SamplePackage": "N",
"IndicationAndUsage": "INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: 1 Schizophrenia in adults [see Clinical Studies (14.1)]. , 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2)]. .",
"Description": "INVEGA SUSTENNA ® contains paliperidone palmitate. The active ingredient, paliperidone, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA SUSTENNA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4 and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate. INVEGA SUSTENNA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (and deliverable volumes) of the single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1.0 mL), and 234 mg (1.5 mL). The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive ingredients are polysorbate 20 (12 mg/mL), polyethylene glycol 4000 (30 mg/mL), citric acid monohydrate (5 mg/mL), disodium hydrogen phosphate anhydrous (5 mg/mL), sodium dihydrogen phosphate monohydrate (2.5 mg/mL), sodium hydroxide (2.84 mg/mL used as an alkalizing agent to set pH at 7), and water for injection. INVEGA SUSTENNA is provided in a single-dose prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains 2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety needle)."
},
{
"NDCCode": "50458-562-01",
"PackageDescription": "1 SYRINGE in 1 KIT (50458-562-01) / .75 mL in 1 SYRINGE",
"NDC11Code": "50458-0562-01",
"ProductNDC": "50458-562",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invega Sustenna",
"NonProprietaryName": "Paliperidone Palmitate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20090731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022264",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "PALIPERIDONE PALMITATE",
"StrengthNumber": "117",
"StrengthUnit": "mg/.75mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090731",
"SamplePackage": "N",
"IndicationAndUsage": "INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: 1 Schizophrenia in adults [see Clinical Studies (14.1)]. , 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2)]. .",
"Description": "INVEGA SUSTENNA ® contains paliperidone palmitate. The active ingredient, paliperidone, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA SUSTENNA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4 and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate. INVEGA SUSTENNA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (and deliverable volumes) of the single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1.0 mL), and 234 mg (1.5 mL). The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive ingredients are polysorbate 20 (12 mg/mL), polyethylene glycol 4000 (30 mg/mL), citric acid monohydrate (5 mg/mL), disodium hydrogen phosphate anhydrous (5 mg/mL), sodium dihydrogen phosphate monohydrate (2.5 mg/mL), sodium hydroxide (2.84 mg/mL used as an alkalizing agent to set pH at 7), and water for injection. INVEGA SUSTENNA is provided in a single-dose prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains 2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety needle)."
},
{
"NDCCode": "50458-563-01",
"PackageDescription": "1 SYRINGE in 1 KIT (50458-563-01) / 1 mL in 1 SYRINGE",
"NDC11Code": "50458-0563-01",
"ProductNDC": "50458-563",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invega Sustenna",
"NonProprietaryName": "Paliperidone Palmitate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20090731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022264",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "PALIPERIDONE PALMITATE",
"StrengthNumber": "156",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090731",
"SamplePackage": "N",
"IndicationAndUsage": "INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: 1 Schizophrenia in adults [see Clinical Studies (14.1)]. , 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2)]. .",
"Description": "INVEGA SUSTENNA ® contains paliperidone palmitate. The active ingredient, paliperidone, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA SUSTENNA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4 and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate. INVEGA SUSTENNA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (and deliverable volumes) of the single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1.0 mL), and 234 mg (1.5 mL). The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive ingredients are polysorbate 20 (12 mg/mL), polyethylene glycol 4000 (30 mg/mL), citric acid monohydrate (5 mg/mL), disodium hydrogen phosphate anhydrous (5 mg/mL), sodium dihydrogen phosphate monohydrate (2.5 mg/mL), sodium hydroxide (2.84 mg/mL used as an alkalizing agent to set pH at 7), and water for injection. INVEGA SUSTENNA is provided in a single-dose prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains 2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety needle)."
},
{
"NDCCode": "50458-563-03",
"PackageDescription": "1 SYRINGE in 1 KIT (50458-563-03) / 1 mL in 1 SYRINGE",
"NDC11Code": "50458-0563-03",
"ProductNDC": "50458-563",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invega Sustenna",
"NonProprietaryName": "Paliperidone Palmitate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20090731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022264",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "PALIPERIDONE PALMITATE",
"StrengthNumber": "156",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090731",
"SamplePackage": "Y",
"IndicationAndUsage": "INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: 1 Schizophrenia in adults [see Clinical Studies (14.1)]. , 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2)]. .",
"Description": "INVEGA SUSTENNA ® contains paliperidone palmitate. The active ingredient, paliperidone, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA SUSTENNA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4 and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate. INVEGA SUSTENNA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (and deliverable volumes) of the single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1.0 mL), and 234 mg (1.5 mL). The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive ingredients are polysorbate 20 (12 mg/mL), polyethylene glycol 4000 (30 mg/mL), citric acid monohydrate (5 mg/mL), disodium hydrogen phosphate anhydrous (5 mg/mL), sodium dihydrogen phosphate monohydrate (2.5 mg/mL), sodium hydroxide (2.84 mg/mL used as an alkalizing agent to set pH at 7), and water for injection. INVEGA SUSTENNA is provided in a single-dose prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains 2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety needle)."
},
{
"NDCCode": "50458-564-01",
"PackageDescription": "1 SYRINGE in 1 KIT (50458-564-01) / 1.5 mL in 1 SYRINGE",
"NDC11Code": "50458-0564-01",
"ProductNDC": "50458-564",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invega Sustenna",
"NonProprietaryName": "Paliperidone Palmitate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20090731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022264",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "PALIPERIDONE PALMITATE",
"StrengthNumber": "234",
"StrengthUnit": "mg/1.5mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090731",
"SamplePackage": "N",
"IndicationAndUsage": "INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: 1 Schizophrenia in adults [see Clinical Studies (14.1)]. , 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2)]. .",
"Description": "INVEGA SUSTENNA ® contains paliperidone palmitate. The active ingredient, paliperidone, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA SUSTENNA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4 and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate. INVEGA SUSTENNA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (and deliverable volumes) of the single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1.0 mL), and 234 mg (1.5 mL). The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive ingredients are polysorbate 20 (12 mg/mL), polyethylene glycol 4000 (30 mg/mL), citric acid monohydrate (5 mg/mL), disodium hydrogen phosphate anhydrous (5 mg/mL), sodium dihydrogen phosphate monohydrate (2.5 mg/mL), sodium hydroxide (2.84 mg/mL used as an alkalizing agent to set pH at 7), and water for injection. INVEGA SUSTENNA is provided in a single-dose prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains 2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety needle)."
},
{
"NDCCode": "50458-564-03",
"PackageDescription": "1 SYRINGE in 1 KIT (50458-564-03) / 1.5 mL in 1 SYRINGE",
"NDC11Code": "50458-0564-03",
"ProductNDC": "50458-564",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invega Sustenna",
"NonProprietaryName": "Paliperidone Palmitate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20090731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022264",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "PALIPERIDONE PALMITATE",
"StrengthNumber": "234",
"StrengthUnit": "mg/1.5mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090731",
"SamplePackage": "Y",
"IndicationAndUsage": "INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: 1 Schizophrenia in adults [see Clinical Studies (14.1)]. , 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2)]. .",
"Description": "INVEGA SUSTENNA ® contains paliperidone palmitate. The active ingredient, paliperidone, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA SUSTENNA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4 and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate. INVEGA SUSTENNA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (and deliverable volumes) of the single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1.0 mL), and 234 mg (1.5 mL). The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive ingredients are polysorbate 20 (12 mg/mL), polyethylene glycol 4000 (30 mg/mL), citric acid monohydrate (5 mg/mL), disodium hydrogen phosphate anhydrous (5 mg/mL), sodium dihydrogen phosphate monohydrate (2.5 mg/mL), sodium hydroxide (2.84 mg/mL used as an alkalizing agent to set pH at 7), and water for injection. INVEGA SUSTENNA is provided in a single-dose prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains 2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety needle)."
},
{
"NDCCode": "71610-117-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (71610-117-30) ",
"NDC11Code": "71610-0117-30",
"ProductNDC": "71610-117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19840911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062505",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180906",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules & Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Capsules & Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Tablets and Capsules for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8∙H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8∙HCl)2∙C2H6O∙H2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Lactose Anhydrous, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Starch Glycolate, and Stearic Acid. 50 mg gelatin capsule shell contains: FD&C Blue #1, D&C Yellow #10, and other inert ingredients. 100 mg gelatin capsule shell contains: FD&C Blue #1 and other inert ingredients. Each tablet, for oral administration, contains doxycycline Hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the following inactive ingredients; anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide."
},
{
"NDCCode": "72526-105-11",
"PackageDescription": "1 SYRINGE, GLASS in 1 KIT (72526-105-11) / .25 mL in 1 SYRINGE, GLASS",
"NDC11Code": "72526-0105-11",
"ProductNDC": "72526-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erzofri Extended-release",
"NonProprietaryName": "Paliperidone Palmitate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20241210",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216352",
"LabelerName": "Shandong Luye Pharmaceutical Co., Ltd.",
"SubstanceName": "PALIPERIDONE PALMITATE",
"StrengthNumber": "39",
"StrengthUnit": "mg/.25mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241210",
"SamplePackage": "N",
"IndicationAndUsage": "ERZOFRI is indicated for the treatment of: 1 Schizophrenia in adults ., 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants .",
"Description": "ERZOFRI (paliperidone palmitate) extended-release injectable suspension contains a racemic mixture of (+)- and (-)- paliperidone palmitate. Paliperidone palmitate, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in water, and slightly soluble in ethyl acetate. ERZOFRI is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (deliverable volume) in single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1 mL), 234 mg (1.5 mL), and 351 mg (2.25 mL). The drug product hydrolyzes in vivo to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, and 225 mg of paliperidone, respectively. The inactive ingredients are citric acid monohydrate (5 mg/mL), dibasic sodium phosphate anhydrous (5 mg/mL), monobasic sodium phosphate monohydrate (2.5 mg/mL), polyethylene glycol 4000 (30 mg/mL), polysorbate 20 (12 mg/mL), sodium hydroxide to adjust pH, and water for injection. The drug product pH is 6.5 to 7.5."
},
{
"NDCCode": "72526-106-11",
"PackageDescription": "1 SYRINGE, GLASS in 1 KIT (72526-106-11) / .5 mL in 1 SYRINGE, GLASS",
"NDC11Code": "72526-0106-11",
"ProductNDC": "72526-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erzofri Extended-release",
"NonProprietaryName": "Paliperidone Palmitate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20241210",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216352",
"LabelerName": "Shandong Luye Pharmaceutical Co., Ltd.",
"SubstanceName": "PALIPERIDONE PALMITATE",
"StrengthNumber": "78",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241210",
"SamplePackage": "N",
"IndicationAndUsage": "ERZOFRI is indicated for the treatment of: 1 Schizophrenia in adults ., 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants .",
"Description": "ERZOFRI (paliperidone palmitate) extended-release injectable suspension contains a racemic mixture of (+)- and (-)- paliperidone palmitate. Paliperidone palmitate, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in water, and slightly soluble in ethyl acetate. ERZOFRI is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (deliverable volume) in single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1 mL), 234 mg (1.5 mL), and 351 mg (2.25 mL). The drug product hydrolyzes in vivo to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, and 225 mg of paliperidone, respectively. The inactive ingredients are citric acid monohydrate (5 mg/mL), dibasic sodium phosphate anhydrous (5 mg/mL), monobasic sodium phosphate monohydrate (2.5 mg/mL), polyethylene glycol 4000 (30 mg/mL), polysorbate 20 (12 mg/mL), sodium hydroxide to adjust pH, and water for injection. The drug product pH is 6.5 to 7.5."
},
{
"NDCCode": "72526-107-11",
"PackageDescription": "1 SYRINGE, GLASS in 1 KIT (72526-107-11) / .75 mL in 1 SYRINGE, GLASS",
"NDC11Code": "72526-0107-11",
"ProductNDC": "72526-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erzofri Extended-release",
"NonProprietaryName": "Paliperidone Palmitate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20241210",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216352",
"LabelerName": "Shandong Luye Pharmaceutical Co., Ltd.",
"SubstanceName": "PALIPERIDONE PALMITATE",
"StrengthNumber": "117",
"StrengthUnit": "mg/.75mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241210",
"SamplePackage": "N",
"IndicationAndUsage": "ERZOFRI is indicated for the treatment of: 1 Schizophrenia in adults ., 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants .",
"Description": "ERZOFRI (paliperidone palmitate) extended-release injectable suspension contains a racemic mixture of (+)- and (-)- paliperidone palmitate. Paliperidone palmitate, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in water, and slightly soluble in ethyl acetate. ERZOFRI is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (deliverable volume) in single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1 mL), 234 mg (1.5 mL), and 351 mg (2.25 mL). The drug product hydrolyzes in vivo to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, and 225 mg of paliperidone, respectively. The inactive ingredients are citric acid monohydrate (5 mg/mL), dibasic sodium phosphate anhydrous (5 mg/mL), monobasic sodium phosphate monohydrate (2.5 mg/mL), polyethylene glycol 4000 (30 mg/mL), polysorbate 20 (12 mg/mL), sodium hydroxide to adjust pH, and water for injection. The drug product pH is 6.5 to 7.5."
},
{
"NDCCode": "72526-108-11",
"PackageDescription": "1 SYRINGE, GLASS in 1 KIT (72526-108-11) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "72526-0108-11",
"ProductNDC": "72526-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erzofri Extended-release",
"NonProprietaryName": "Paliperidone Palmitate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20241210",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216352",
"LabelerName": "Shandong Luye Pharmaceutical Co., Ltd.",
"SubstanceName": "PALIPERIDONE PALMITATE",
"StrengthNumber": "156",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241210",
"SamplePackage": "N",
"IndicationAndUsage": "ERZOFRI is indicated for the treatment of: 1 Schizophrenia in adults ., 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants .",
"Description": "ERZOFRI (paliperidone palmitate) extended-release injectable suspension contains a racemic mixture of (+)- and (-)- paliperidone palmitate. Paliperidone palmitate, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in water, and slightly soluble in ethyl acetate. ERZOFRI is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (deliverable volume) in single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1 mL), 234 mg (1.5 mL), and 351 mg (2.25 mL). The drug product hydrolyzes in vivo to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, and 225 mg of paliperidone, respectively. The inactive ingredients are citric acid monohydrate (5 mg/mL), dibasic sodium phosphate anhydrous (5 mg/mL), monobasic sodium phosphate monohydrate (2.5 mg/mL), polyethylene glycol 4000 (30 mg/mL), polysorbate 20 (12 mg/mL), sodium hydroxide to adjust pH, and water for injection. The drug product pH is 6.5 to 7.5."
},
{
"NDCCode": "72526-109-11",
"PackageDescription": "1 SYRINGE, GLASS in 1 KIT (72526-109-11) / 1.5 mL in 1 SYRINGE, GLASS",
"NDC11Code": "72526-0109-11",
"ProductNDC": "72526-109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erzofri Extended-release",
"NonProprietaryName": "Paliperidone Palmitate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20241210",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216352",
"LabelerName": "Shandong Luye Pharmaceutical Co., Ltd.",
"SubstanceName": "PALIPERIDONE PALMITATE",
"StrengthNumber": "234",
"StrengthUnit": "mg/1.5mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
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"IndicationAndUsage": "ERZOFRI is indicated for the treatment of: 1 Schizophrenia in adults ., 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants .",
"Description": "ERZOFRI (paliperidone palmitate) extended-release injectable suspension contains a racemic mixture of (+)- and (-)- paliperidone palmitate. Paliperidone palmitate, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in water, and slightly soluble in ethyl acetate. ERZOFRI is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (deliverable volume) in single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1 mL), 234 mg (1.5 mL), and 351 mg (2.25 mL). The drug product hydrolyzes in vivo to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, and 225 mg of paliperidone, respectively. The inactive ingredients are citric acid monohydrate (5 mg/mL), dibasic sodium phosphate anhydrous (5 mg/mL), monobasic sodium phosphate monohydrate (2.5 mg/mL), polyethylene glycol 4000 (30 mg/mL), polysorbate 20 (12 mg/mL), sodium hydroxide to adjust pH, and water for injection. The drug product pH is 6.5 to 7.5."
},
{
"NDCCode": "72526-110-11",
"PackageDescription": "1 SYRINGE, GLASS in 1 KIT (72526-110-11) / 2.25 mL in 1 SYRINGE, GLASS",
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"IndicationAndUsage": "ERZOFRI is indicated for the treatment of: 1 Schizophrenia in adults ., 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants .",
"Description": "ERZOFRI (paliperidone palmitate) extended-release injectable suspension contains a racemic mixture of (+)- and (-)- paliperidone palmitate. Paliperidone palmitate, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in water, and slightly soluble in ethyl acetate. ERZOFRI is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (deliverable volume) in single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1 mL), 234 mg (1.5 mL), and 351 mg (2.25 mL). The drug product hydrolyzes in vivo to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, and 225 mg of paliperidone, respectively. The inactive ingredients are citric acid monohydrate (5 mg/mL), dibasic sodium phosphate anhydrous (5 mg/mL), monobasic sodium phosphate monohydrate (2.5 mg/mL), polyethylene glycol 4000 (30 mg/mL), polysorbate 20 (12 mg/mL), sodium hydroxide to adjust pH, and water for injection. The drug product pH is 6.5 to 7.5."
},
{
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"PackageDescription": "1 SYRINGE, GLASS in 1 KIT (72526-110-21) / 2.25 mL in 1 SYRINGE, GLASS",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Shandong Luye Pharmaceutical Co., Ltd.",
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"StrengthUnit": "mg/2.25mL",
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"SamplePackage": "Y",
"IndicationAndUsage": "ERZOFRI is indicated for the treatment of: 1 Schizophrenia in adults ., 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants .",
"Description": "ERZOFRI (paliperidone palmitate) extended-release injectable suspension contains a racemic mixture of (+)- and (-)- paliperidone palmitate. Paliperidone palmitate, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in water, and slightly soluble in ethyl acetate. ERZOFRI is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (deliverable volume) in single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1 mL), 234 mg (1.5 mL), and 351 mg (2.25 mL). The drug product hydrolyzes in vivo to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, and 225 mg of paliperidone, respectively. The inactive ingredients are citric acid monohydrate (5 mg/mL), dibasic sodium phosphate anhydrous (5 mg/mL), monobasic sodium phosphate monohydrate (2.5 mg/mL), polyethylene glycol 4000 (30 mg/mL), polysorbate 20 (12 mg/mL), sodium hydroxide to adjust pH, and water for injection. The drug product pH is 6.5 to 7.5."
}
]
}
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Invega Sustenna</ProprietaryName>
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<Status>Active</Status>
<LastUpdate>2025-02-18</LastUpdate>
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<IndicationAndUsage>INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: 1 Schizophrenia in adults [see Clinical Studies (14.1)]. , 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2)]. .</IndicationAndUsage>
<Description>INVEGA SUSTENNA ® contains paliperidone palmitate. The active ingredient, paliperidone, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA SUSTENNA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4 and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate. INVEGA SUSTENNA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (and deliverable volumes) of the single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1.0 mL), and 234 mg (1.5 mL). The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive ingredients are polysorbate 20 (12 mg/mL), polyethylene glycol 4000 (30 mg/mL), citric acid monohydrate (5 mg/mL), disodium hydrogen phosphate anhydrous (5 mg/mL), sodium dihydrogen phosphate monohydrate (2.5 mg/mL), sodium hydroxide (2.84 mg/mL used as an alkalizing agent to set pH at 7), and water for injection. INVEGA SUSTENNA is provided in a single-dose prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains 2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety needle).</Description>
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<NDC11Code>50458-0561-01</NDC11Code>
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<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: 1 Schizophrenia in adults [see Clinical Studies (14.1)]. , 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2)]. .</IndicationAndUsage>
<Description>INVEGA SUSTENNA ® contains paliperidone palmitate. The active ingredient, paliperidone, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA SUSTENNA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4 and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate. INVEGA SUSTENNA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (and deliverable volumes) of the single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1.0 mL), and 234 mg (1.5 mL). The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive ingredients are polysorbate 20 (12 mg/mL), polyethylene glycol 4000 (30 mg/mL), citric acid monohydrate (5 mg/mL), disodium hydrogen phosphate anhydrous (5 mg/mL), sodium dihydrogen phosphate monohydrate (2.5 mg/mL), sodium hydroxide (2.84 mg/mL used as an alkalizing agent to set pH at 7), and water for injection. INVEGA SUSTENNA is provided in a single-dose prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains 2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety needle).</Description>
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<NDC>
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<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: 1 Schizophrenia in adults [see Clinical Studies (14.1)]. , 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2)]. .</IndicationAndUsage>
<Description>INVEGA SUSTENNA ® contains paliperidone palmitate. The active ingredient, paliperidone, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA SUSTENNA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4 and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate. INVEGA SUSTENNA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (and deliverable volumes) of the single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1.0 mL), and 234 mg (1.5 mL). The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive ingredients are polysorbate 20 (12 mg/mL), polyethylene glycol 4000 (30 mg/mL), citric acid monohydrate (5 mg/mL), disodium hydrogen phosphate anhydrous (5 mg/mL), sodium dihydrogen phosphate monohydrate (2.5 mg/mL), sodium hydroxide (2.84 mg/mL used as an alkalizing agent to set pH at 7), and water for injection. INVEGA SUSTENNA is provided in a single-dose prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains 2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety needle).</Description>
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<IndicationAndUsage>INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: 1 Schizophrenia in adults [see Clinical Studies (14.1)]. , 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2)]. .</IndicationAndUsage>
<Description>INVEGA SUSTENNA ® contains paliperidone palmitate. The active ingredient, paliperidone, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA SUSTENNA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4 and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate. INVEGA SUSTENNA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (and deliverable volumes) of the single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1.0 mL), and 234 mg (1.5 mL). The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive ingredients are polysorbate 20 (12 mg/mL), polyethylene glycol 4000 (30 mg/mL), citric acid monohydrate (5 mg/mL), disodium hydrogen phosphate anhydrous (5 mg/mL), sodium dihydrogen phosphate monohydrate (2.5 mg/mL), sodium hydroxide (2.84 mg/mL used as an alkalizing agent to set pH at 7), and water for injection. INVEGA SUSTENNA is provided in a single-dose prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains 2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety needle).</Description>
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<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: 1 Schizophrenia in adults [see Clinical Studies (14.1)]. , 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2)]. .</IndicationAndUsage>
<Description>INVEGA SUSTENNA ® contains paliperidone palmitate. The active ingredient, paliperidone, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA SUSTENNA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4 and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate. INVEGA SUSTENNA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (and deliverable volumes) of the single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1.0 mL), and 234 mg (1.5 mL). The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive ingredients are polysorbate 20 (12 mg/mL), polyethylene glycol 4000 (30 mg/mL), citric acid monohydrate (5 mg/mL), disodium hydrogen phosphate anhydrous (5 mg/mL), sodium dihydrogen phosphate monohydrate (2.5 mg/mL), sodium hydroxide (2.84 mg/mL used as an alkalizing agent to set pH at 7), and water for injection. INVEGA SUSTENNA is provided in a single-dose prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains 2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety needle).</Description>
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<IndicationAndUsage>INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: 1 Schizophrenia in adults [see Clinical Studies (14.1)]. , 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2)]. .</IndicationAndUsage>
<Description>INVEGA SUSTENNA ® contains paliperidone palmitate. The active ingredient, paliperidone, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA SUSTENNA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4 and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate. INVEGA SUSTENNA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (and deliverable volumes) of the single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1.0 mL), and 234 mg (1.5 mL). The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive ingredients are polysorbate 20 (12 mg/mL), polyethylene glycol 4000 (30 mg/mL), citric acid monohydrate (5 mg/mL), disodium hydrogen phosphate anhydrous (5 mg/mL), sodium dihydrogen phosphate monohydrate (2.5 mg/mL), sodium hydroxide (2.84 mg/mL used as an alkalizing agent to set pH at 7), and water for injection. INVEGA SUSTENNA is provided in a single-dose prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains 2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety needle).</Description>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: 1 Schizophrenia in adults [see Clinical Studies (14.1)]. , 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2)]. .</IndicationAndUsage>
<Description>INVEGA SUSTENNA ® contains paliperidone palmitate. The active ingredient, paliperidone, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA SUSTENNA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4 and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate. INVEGA SUSTENNA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (and deliverable volumes) of the single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1.0 mL), and 234 mg (1.5 mL). The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive ingredients are polysorbate 20 (12 mg/mL), polyethylene glycol 4000 (30 mg/mL), citric acid monohydrate (5 mg/mL), disodium hydrogen phosphate anhydrous (5 mg/mL), sodium dihydrogen phosphate monohydrate (2.5 mg/mL), sodium hydroxide (2.84 mg/mL used as an alkalizing agent to set pH at 7), and water for injection. INVEGA SUSTENNA is provided in a single-dose prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains 2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety needle).</Description>
</NDC>
<NDC>
<NDCCode>71610-117-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (71610-117-30) </PackageDescription>
<NDC11Code>71610-0117-30</NDC11Code>
<ProductNDC>71610-117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062505</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules & Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Capsules & Doxycycline Hyclate Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate Tablets and Capsules for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8∙H2O and a molecular weight of 462.46. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8∙HCl)2∙C2H6O∙H2O and the molecular weight is 1025.89. Doxycycline is a light-yellow crystalline powder. Doxycycline hyclate is soluble in water, while doxycycline monohydrate is very slightly soluble in water. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg of doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon Dioxide, Lactose Anhydrous, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Starch Glycolate, and Stearic Acid. 50 mg gelatin capsule shell contains: FD&C Blue #1, D&C Yellow #10, and other inert ingredients. 100 mg gelatin capsule shell contains: FD&C Blue #1 and other inert ingredients. Each tablet, for oral administration, contains doxycycline Hyclate equivalent to 100 mg doxycycline. In addition, each tablet contains the following inactive ingredients; anhydrous lactose, colloidal silicon dioxide, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>72526-105-11</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 KIT (72526-105-11) / .25 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>72526-0105-11</NDC11Code>
<ProductNDC>72526-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erzofri Extended-release</ProprietaryName>
<NonProprietaryName>Paliperidone Palmitate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20241210</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216352</ApplicationNumber>
<LabelerName>Shandong Luye Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>PALIPERIDONE PALMITATE</SubstanceName>
<StrengthNumber>39</StrengthNumber>
<StrengthUnit>mg/.25mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ERZOFRI is indicated for the treatment of: 1 Schizophrenia in adults ., 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants .</IndicationAndUsage>
<Description>ERZOFRI (paliperidone palmitate) extended-release injectable suspension contains a racemic mixture of (+)- and (-)- paliperidone palmitate. Paliperidone palmitate, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in water, and slightly soluble in ethyl acetate. ERZOFRI is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (deliverable volume) in single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1 mL), 234 mg (1.5 mL), and 351 mg (2.25 mL). The drug product hydrolyzes in vivo to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, and 225 mg of paliperidone, respectively. The inactive ingredients are citric acid monohydrate (5 mg/mL), dibasic sodium phosphate anhydrous (5 mg/mL), monobasic sodium phosphate monohydrate (2.5 mg/mL), polyethylene glycol 4000 (30 mg/mL), polysorbate 20 (12 mg/mL), sodium hydroxide to adjust pH, and water for injection. The drug product pH is 6.5 to 7.5.</Description>
</NDC>
<NDC>
<NDCCode>72526-106-11</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 KIT (72526-106-11) / .5 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>72526-0106-11</NDC11Code>
<ProductNDC>72526-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erzofri Extended-release</ProprietaryName>
<NonProprietaryName>Paliperidone Palmitate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20241210</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216352</ApplicationNumber>
<LabelerName>Shandong Luye Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>PALIPERIDONE PALMITATE</SubstanceName>
<StrengthNumber>78</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ERZOFRI is indicated for the treatment of: 1 Schizophrenia in adults ., 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants .</IndicationAndUsage>
<Description>ERZOFRI (paliperidone palmitate) extended-release injectable suspension contains a racemic mixture of (+)- and (-)- paliperidone palmitate. Paliperidone palmitate, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in water, and slightly soluble in ethyl acetate. ERZOFRI is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (deliverable volume) in single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1 mL), 234 mg (1.5 mL), and 351 mg (2.25 mL). The drug product hydrolyzes in vivo to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, and 225 mg of paliperidone, respectively. The inactive ingredients are citric acid monohydrate (5 mg/mL), dibasic sodium phosphate anhydrous (5 mg/mL), monobasic sodium phosphate monohydrate (2.5 mg/mL), polyethylene glycol 4000 (30 mg/mL), polysorbate 20 (12 mg/mL), sodium hydroxide to adjust pH, and water for injection. The drug product pH is 6.5 to 7.5.</Description>
</NDC>
<NDC>
<NDCCode>72526-107-11</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 KIT (72526-107-11) / .75 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>72526-0107-11</NDC11Code>
<ProductNDC>72526-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erzofri Extended-release</ProprietaryName>
<NonProprietaryName>Paliperidone Palmitate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20241210</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216352</ApplicationNumber>
<LabelerName>Shandong Luye Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>PALIPERIDONE PALMITATE</SubstanceName>
<StrengthNumber>117</StrengthNumber>
<StrengthUnit>mg/.75mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ERZOFRI is indicated for the treatment of: 1 Schizophrenia in adults ., 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants .</IndicationAndUsage>
<Description>ERZOFRI (paliperidone palmitate) extended-release injectable suspension contains a racemic mixture of (+)- and (-)- paliperidone palmitate. Paliperidone palmitate, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in water, and slightly soluble in ethyl acetate. ERZOFRI is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (deliverable volume) in single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1 mL), 234 mg (1.5 mL), and 351 mg (2.25 mL). The drug product hydrolyzes in vivo to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, and 225 mg of paliperidone, respectively. The inactive ingredients are citric acid monohydrate (5 mg/mL), dibasic sodium phosphate anhydrous (5 mg/mL), monobasic sodium phosphate monohydrate (2.5 mg/mL), polyethylene glycol 4000 (30 mg/mL), polysorbate 20 (12 mg/mL), sodium hydroxide to adjust pH, and water for injection. The drug product pH is 6.5 to 7.5.</Description>
</NDC>
<NDC>
<NDCCode>72526-108-11</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 KIT (72526-108-11) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>72526-0108-11</NDC11Code>
<ProductNDC>72526-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erzofri Extended-release</ProprietaryName>
<NonProprietaryName>Paliperidone Palmitate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20241210</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216352</ApplicationNumber>
<LabelerName>Shandong Luye Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>PALIPERIDONE PALMITATE</SubstanceName>
<StrengthNumber>156</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ERZOFRI is indicated for the treatment of: 1 Schizophrenia in adults ., 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants .</IndicationAndUsage>
<Description>ERZOFRI (paliperidone palmitate) extended-release injectable suspension contains a racemic mixture of (+)- and (-)- paliperidone palmitate. Paliperidone palmitate, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in water, and slightly soluble in ethyl acetate. ERZOFRI is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (deliverable volume) in single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1 mL), 234 mg (1.5 mL), and 351 mg (2.25 mL). The drug product hydrolyzes in vivo to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, and 225 mg of paliperidone, respectively. The inactive ingredients are citric acid monohydrate (5 mg/mL), dibasic sodium phosphate anhydrous (5 mg/mL), monobasic sodium phosphate monohydrate (2.5 mg/mL), polyethylene glycol 4000 (30 mg/mL), polysorbate 20 (12 mg/mL), sodium hydroxide to adjust pH, and water for injection. The drug product pH is 6.5 to 7.5.</Description>
</NDC>
<NDC>
<NDCCode>72526-109-11</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 KIT (72526-109-11) / 1.5 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>72526-0109-11</NDC11Code>
<ProductNDC>72526-109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erzofri Extended-release</ProprietaryName>
<NonProprietaryName>Paliperidone Palmitate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20241210</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216352</ApplicationNumber>
<LabelerName>Shandong Luye Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>PALIPERIDONE PALMITATE</SubstanceName>
<StrengthNumber>234</StrengthNumber>
<StrengthUnit>mg/1.5mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ERZOFRI is indicated for the treatment of: 1 Schizophrenia in adults ., 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants .</IndicationAndUsage>
<Description>ERZOFRI (paliperidone palmitate) extended-release injectable suspension contains a racemic mixture of (+)- and (-)- paliperidone palmitate. Paliperidone palmitate, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in water, and slightly soluble in ethyl acetate. ERZOFRI is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (deliverable volume) in single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1 mL), 234 mg (1.5 mL), and 351 mg (2.25 mL). The drug product hydrolyzes in vivo to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, and 225 mg of paliperidone, respectively. The inactive ingredients are citric acid monohydrate (5 mg/mL), dibasic sodium phosphate anhydrous (5 mg/mL), monobasic sodium phosphate monohydrate (2.5 mg/mL), polyethylene glycol 4000 (30 mg/mL), polysorbate 20 (12 mg/mL), sodium hydroxide to adjust pH, and water for injection. The drug product pH is 6.5 to 7.5.</Description>
</NDC>
<NDC>
<NDCCode>72526-110-11</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 KIT (72526-110-11) / 2.25 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>72526-0110-11</NDC11Code>
<ProductNDC>72526-110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erzofri Extended-release</ProprietaryName>
<NonProprietaryName>Paliperidone Palmitate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20241210</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216352</ApplicationNumber>
<LabelerName>Shandong Luye Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>PALIPERIDONE PALMITATE</SubstanceName>
<StrengthNumber>351</StrengthNumber>
<StrengthUnit>mg/2.25mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ERZOFRI is indicated for the treatment of: 1 Schizophrenia in adults ., 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants .</IndicationAndUsage>
<Description>ERZOFRI (paliperidone palmitate) extended-release injectable suspension contains a racemic mixture of (+)- and (-)- paliperidone palmitate. Paliperidone palmitate, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in water, and slightly soluble in ethyl acetate. ERZOFRI is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (deliverable volume) in single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1 mL), 234 mg (1.5 mL), and 351 mg (2.25 mL). The drug product hydrolyzes in vivo to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, and 225 mg of paliperidone, respectively. The inactive ingredients are citric acid monohydrate (5 mg/mL), dibasic sodium phosphate anhydrous (5 mg/mL), monobasic sodium phosphate monohydrate (2.5 mg/mL), polyethylene glycol 4000 (30 mg/mL), polysorbate 20 (12 mg/mL), sodium hydroxide to adjust pH, and water for injection. The drug product pH is 6.5 to 7.5.</Description>
</NDC>
<NDC>
<NDCCode>72526-110-21</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 KIT (72526-110-21) / 2.25 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>72526-0110-21</NDC11Code>
<ProductNDC>72526-110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erzofri Extended-release</ProprietaryName>
<NonProprietaryName>Paliperidone Palmitate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20241210</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216352</ApplicationNumber>
<LabelerName>Shandong Luye Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>PALIPERIDONE PALMITATE</SubstanceName>
<StrengthNumber>351</StrengthNumber>
<StrengthUnit>mg/2.25mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250320</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>ERZOFRI is indicated for the treatment of: 1 Schizophrenia in adults ., 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants .</IndicationAndUsage>
<Description>ERZOFRI (paliperidone palmitate) extended-release injectable suspension contains a racemic mixture of (+)- and (-)- paliperidone palmitate. Paliperidone palmitate, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in water, and slightly soluble in ethyl acetate. ERZOFRI is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (deliverable volume) in single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1 mL), 234 mg (1.5 mL), and 351 mg (2.25 mL). The drug product hydrolyzes in vivo to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, and 225 mg of paliperidone, respectively. The inactive ingredients are citric acid monohydrate (5 mg/mL), dibasic sodium phosphate anhydrous (5 mg/mL), monobasic sodium phosphate monohydrate (2.5 mg/mL), polyethylene glycol 4000 (30 mg/mL), polysorbate 20 (12 mg/mL), sodium hydroxide to adjust pH, and water for injection. The drug product pH is 6.5 to 7.5.</Description>
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