{
"NDC": [
{
"NDCCode": "59148-034-61",
"PackageDescription": "1 BOTTLE in 1 KIT (59148-034-61) / 30 TABLET WITH SENSOR in 1 BOTTLE (59148-034-13) ",
"NDC11Code": "59148-0034-61",
"ProductNDC": "59148-034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify Mycite",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET WITH SENSOR",
"RouteName": "ORAL",
"StartMarketingDate": "20180131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207202",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201219",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the: 1 Treatment of adults with schizophrenia., 2 Treatment of bipolar I disorderAcute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate.Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate., 3 Adjunctive treatment of adults with Major Depressive Disorder. .",
"Description": "ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product containing aripiprazole, an atypical antipsychotic, embedded with an Ingestible Event Marker (IEM) sensor. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY MYCITE is available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strength tablets with sensor. Inactive ingredients of the tablets with sensor include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. Ingredients of the IEM include aluminum, cuprous chloride, ethyl cellulose, gold, hydroxypropyl cellulose, magnesium, silicon, silicon dioxide, silicon nitride, titanium-tungsten, titanium and triethyl citrate. The ABILIFY MYCITE System is a drug-device combination product composed of the following components: 1 An aripiprazole tablet with an embedded Ingestible Event Marker (IEM) sensor. The IEM is a 1 mm sized sensor embedded in the ABILIFY MYCITE tablets with sensor. Upon contact with gastric fluid, magnesium and cuprous chloride within the IEM react to activate and power the device. The IEM then communicates to the MYCITE Patch, to track aripiprazole ingestion., 2 A MYCITE Patch (wearable sensor) is designed to detect the ingestion of the ABILIFY MYCITE tablets with sensor, record the ingestion of the IEM, and transmit ingestion data to the mobile patient application (app)., 3 A compatible app displays this data to allow patients to review their medication ingestion. These data can be shared with healthcare providers and caregivers., 4 Web-based portal or dashboard for healthcare professionals and caregivers."
},
{
"NDCCode": "82761-034-61",
"PackageDescription": "1 TUBE in 1 CARTON (82761-034-61) / 25 mL in 1 TUBE",
"NDC11Code": "82761-0034-61",
"ProductNDC": "82761-034",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laura Mercier Tinted Moisturizer Oil Free Natural Skin Perfector Broad Spectrum Spf 20 Sunscreen",
"ProprietaryNameSuffix": "6w1 Ganache",
"NonProprietaryName": "Octinoxate And Octisalate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Laura Mercier US Buyer LLC",
"SubstanceName": "OCTINOXATE; OCTISALATE",
"StrengthNumber": "2.827; 1.542",
"StrengthUnit": "g/50mL; g/50mL",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220831",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "59148-034-72",
"PackageDescription": "1 BOTTLE in 1 KIT (59148-034-72) / 30 TABLET WITH SENSOR in 1 BOTTLE (59148-034-13) ",
"NDC11Code": "59148-0034-72",
"ProductNDC": "59148-034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify Mycite",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET WITH SENSOR",
"RouteName": "ORAL",
"StartMarketingDate": "20180131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207202",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201219",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the: 1 Treatment of adults with schizophrenia., 2 Treatment of bipolar I disorderAcute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate.Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate., 3 Adjunctive treatment of adults with Major Depressive Disorder. .",
"Description": "ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product containing aripiprazole, an atypical antipsychotic, embedded with an Ingestible Event Marker (IEM) sensor. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY MYCITE is available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strength tablets with sensor. Inactive ingredients of the tablets with sensor include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. Ingredients of the IEM include aluminum, cuprous chloride, ethyl cellulose, gold, hydroxypropyl cellulose, magnesium, silicon, silicon dioxide, silicon nitride, titanium-tungsten, titanium and triethyl citrate. The ABILIFY MYCITE System is a drug-device combination product composed of the following components: 1 An aripiprazole tablet with an embedded Ingestible Event Marker (IEM) sensor. The IEM is a 1 mm sized sensor embedded in the ABILIFY MYCITE tablets with sensor. Upon contact with gastric fluid, magnesium and cuprous chloride within the IEM react to activate and power the device. The IEM then communicates to the MYCITE Patch, to track aripiprazole ingestion., 2 A MYCITE Patch (wearable sensor) is designed to detect the ingestion of the ABILIFY MYCITE tablets with sensor, record the ingestion of the IEM, and transmit ingestion data to the mobile patient application (app)., 3 A compatible app displays this data to allow patients to review their medication ingestion. These data can be shared with healthcare providers and caregivers., 4 Web-based portal or dashboard for healthcare professionals and caregivers."
},
{
"NDCCode": "59148-034-85",
"PackageDescription": "1 BOTTLE in 1 KIT (59148-034-85) > 30 TABLET WITH SENSOR in 1 BOTTLE (59148-034-13) ",
"NDC11Code": "59148-0034-85",
"ProductNDC": "59148-034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify Mycite",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET WITH SENSOR",
"RouteName": "ORAL",
"StartMarketingDate": "20180131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207202",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180131",
"SamplePackage": "N"
},
{
"NDCCode": "59148-034-90",
"PackageDescription": "1 BOTTLE in 1 KIT (59148-034-90) / 7 TABLET WITH SENSOR in 1 BOTTLE (59148-034-07) ",
"NDC11Code": "59148-0034-90",
"ProductNDC": "59148-034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify Mycite",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET WITH SENSOR",
"RouteName": "ORAL",
"StartMarketingDate": "20180131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207202",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180131",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the: 1 Treatment of adults with schizophrenia., 2 Treatment of bipolar I disorderAcute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate.Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate., 3 Adjunctive treatment of adults with Major Depressive Disorder. .",
"Description": "ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product containing aripiprazole, an atypical antipsychotic, embedded with an Ingestible Event Marker (IEM) sensor. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY MYCITE is available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strength tablets with sensor. Inactive ingredients of the tablets with sensor include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. Ingredients of the IEM include aluminum, cuprous chloride, ethyl cellulose, gold, hydroxypropyl cellulose, magnesium, silicon, silicon dioxide, silicon nitride, titanium-tungsten, titanium and triethyl citrate. The ABILIFY MYCITE System is a drug-device combination product composed of the following components: 1 An aripiprazole tablet with an embedded Ingestible Event Marker (IEM) sensor. The IEM is a 1 mm sized sensor embedded in the ABILIFY MYCITE tablets with sensor. Upon contact with gastric fluid, magnesium and cuprous chloride within the IEM react to activate and power the device. The IEM then communicates to the MYCITE Patch, to track aripiprazole ingestion., 2 A MYCITE Patch (wearable sensor) is designed to detect the ingestion of the ABILIFY MYCITE tablets with sensor, record the ingestion of the IEM, and transmit ingestion data to the mobile patient application (app)., 3 A compatible app displays this data to allow patients to review their medication ingestion. These data can be shared with healthcare providers and caregivers., 4 Web-based portal or dashboard for healthcare professionals and caregivers."
},
{
"NDCCode": "59148-029-61",
"PackageDescription": "1 BOTTLE in 1 KIT (59148-029-61) / 30 TABLET WITH SENSOR in 1 BOTTLE (59148-029-13) ",
"NDC11Code": "59148-0029-61",
"ProductNDC": "59148-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify Mycite",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET WITH SENSOR",
"RouteName": "ORAL",
"StartMarketingDate": "20180131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207202",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201219",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the: 1 Treatment of adults with schizophrenia., 2 Treatment of bipolar I disorderAcute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate.Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate., 3 Adjunctive treatment of adults with Major Depressive Disorder. .",
"Description": "ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product containing aripiprazole, an atypical antipsychotic, embedded with an Ingestible Event Marker (IEM) sensor. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY MYCITE is available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strength tablets with sensor. Inactive ingredients of the tablets with sensor include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. Ingredients of the IEM include aluminum, cuprous chloride, ethyl cellulose, gold, hydroxypropyl cellulose, magnesium, silicon, silicon dioxide, silicon nitride, titanium-tungsten, titanium and triethyl citrate. The ABILIFY MYCITE System is a drug-device combination product composed of the following components: 1 An aripiprazole tablet with an embedded Ingestible Event Marker (IEM) sensor. The IEM is a 1 mm sized sensor embedded in the ABILIFY MYCITE tablets with sensor. Upon contact with gastric fluid, magnesium and cuprous chloride within the IEM react to activate and power the device. The IEM then communicates to the MYCITE Patch, to track aripiprazole ingestion., 2 A MYCITE Patch (wearable sensor) is designed to detect the ingestion of the ABILIFY MYCITE tablets with sensor, record the ingestion of the IEM, and transmit ingestion data to the mobile patient application (app)., 3 A compatible app displays this data to allow patients to review their medication ingestion. These data can be shared with healthcare providers and caregivers., 4 Web-based portal or dashboard for healthcare professionals and caregivers."
},
{
"NDCCode": "59148-030-61",
"PackageDescription": "1 BOTTLE in 1 KIT (59148-030-61) / 30 TABLET WITH SENSOR in 1 BOTTLE (59148-030-13) ",
"NDC11Code": "59148-0030-61",
"ProductNDC": "59148-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify Mycite",
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"DosageFormName": "TABLET WITH SENSOR",
"RouteName": "ORAL",
"StartMarketingDate": "20180131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207202",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the: 1 Treatment of adults with schizophrenia., 2 Treatment of bipolar I disorderAcute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate.Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate., 3 Adjunctive treatment of adults with Major Depressive Disorder. .",
"Description": "ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product containing aripiprazole, an atypical antipsychotic, embedded with an Ingestible Event Marker (IEM) sensor. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY MYCITE is available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strength tablets with sensor. Inactive ingredients of the tablets with sensor include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. Ingredients of the IEM include aluminum, cuprous chloride, ethyl cellulose, gold, hydroxypropyl cellulose, magnesium, silicon, silicon dioxide, silicon nitride, titanium-tungsten, titanium and triethyl citrate. The ABILIFY MYCITE System is a drug-device combination product composed of the following components: 1 An aripiprazole tablet with an embedded Ingestible Event Marker (IEM) sensor. The IEM is a 1 mm sized sensor embedded in the ABILIFY MYCITE tablets with sensor. Upon contact with gastric fluid, magnesium and cuprous chloride within the IEM react to activate and power the device. The IEM then communicates to the MYCITE Patch, to track aripiprazole ingestion., 2 A MYCITE Patch (wearable sensor) is designed to detect the ingestion of the ABILIFY MYCITE tablets with sensor, record the ingestion of the IEM, and transmit ingestion data to the mobile patient application (app)., 3 A compatible app displays this data to allow patients to review their medication ingestion. These data can be shared with healthcare providers and caregivers., 4 Web-based portal or dashboard for healthcare professionals and caregivers."
},
{
"NDCCode": "59148-031-61",
"PackageDescription": "1 BOTTLE in 1 KIT (59148-031-61) / 30 TABLET WITH SENSOR in 1 BOTTLE (59148-031-13) ",
"NDC11Code": "59148-0031-61",
"ProductNDC": "59148-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify Mycite",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET WITH SENSOR",
"RouteName": "ORAL",
"StartMarketingDate": "20180131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207202",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
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"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the: 1 Treatment of adults with schizophrenia., 2 Treatment of bipolar I disorderAcute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate.Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate., 3 Adjunctive treatment of adults with Major Depressive Disorder. .",
"Description": "ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product containing aripiprazole, an atypical antipsychotic, embedded with an Ingestible Event Marker (IEM) sensor. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY MYCITE is available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strength tablets with sensor. Inactive ingredients of the tablets with sensor include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. Ingredients of the IEM include aluminum, cuprous chloride, ethyl cellulose, gold, hydroxypropyl cellulose, magnesium, silicon, silicon dioxide, silicon nitride, titanium-tungsten, titanium and triethyl citrate. The ABILIFY MYCITE System is a drug-device combination product composed of the following components: 1 An aripiprazole tablet with an embedded Ingestible Event Marker (IEM) sensor. The IEM is a 1 mm sized sensor embedded in the ABILIFY MYCITE tablets with sensor. Upon contact with gastric fluid, magnesium and cuprous chloride within the IEM react to activate and power the device. The IEM then communicates to the MYCITE Patch, to track aripiprazole ingestion., 2 A MYCITE Patch (wearable sensor) is designed to detect the ingestion of the ABILIFY MYCITE tablets with sensor, record the ingestion of the IEM, and transmit ingestion data to the mobile patient application (app)., 3 A compatible app displays this data to allow patients to review their medication ingestion. These data can be shared with healthcare providers and caregivers., 4 Web-based portal or dashboard for healthcare professionals and caregivers."
},
{
"NDCCode": "59148-032-61",
"PackageDescription": "1 BOTTLE in 1 KIT (59148-032-61) / 30 TABLET WITH SENSOR in 1 BOTTLE (59148-032-13) ",
"NDC11Code": "59148-0032-61",
"ProductNDC": "59148-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify Mycite",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET WITH SENSOR",
"RouteName": "ORAL",
"StartMarketingDate": "20180131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207202",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
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"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the: 1 Treatment of adults with schizophrenia., 2 Treatment of bipolar I disorderAcute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate.Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate., 3 Adjunctive treatment of adults with Major Depressive Disorder. .",
"Description": "ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product containing aripiprazole, an atypical antipsychotic, embedded with an Ingestible Event Marker (IEM) sensor. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY MYCITE is available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strength tablets with sensor. Inactive ingredients of the tablets with sensor include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. Ingredients of the IEM include aluminum, cuprous chloride, ethyl cellulose, gold, hydroxypropyl cellulose, magnesium, silicon, silicon dioxide, silicon nitride, titanium-tungsten, titanium and triethyl citrate. The ABILIFY MYCITE System is a drug-device combination product composed of the following components: 1 An aripiprazole tablet with an embedded Ingestible Event Marker (IEM) sensor. The IEM is a 1 mm sized sensor embedded in the ABILIFY MYCITE tablets with sensor. Upon contact with gastric fluid, magnesium and cuprous chloride within the IEM react to activate and power the device. The IEM then communicates to the MYCITE Patch, to track aripiprazole ingestion., 2 A MYCITE Patch (wearable sensor) is designed to detect the ingestion of the ABILIFY MYCITE tablets with sensor, record the ingestion of the IEM, and transmit ingestion data to the mobile patient application (app)., 3 A compatible app displays this data to allow patients to review their medication ingestion. These data can be shared with healthcare providers and caregivers., 4 Web-based portal or dashboard for healthcare professionals and caregivers."
},
{
"NDCCode": "59148-033-61",
"PackageDescription": "1 BOTTLE in 1 KIT (59148-033-61) / 30 TABLET WITH SENSOR in 1 BOTTLE (59148-033-13) ",
"NDC11Code": "59148-0033-61",
"ProductNDC": "59148-033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify Mycite",
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"DosageFormName": "TABLET WITH SENSOR",
"RouteName": "ORAL",
"StartMarketingDate": "20180131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207202",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201219",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the: 1 Treatment of adults with schizophrenia., 2 Treatment of bipolar I disorderAcute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate.Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate., 3 Adjunctive treatment of adults with Major Depressive Disorder. .",
"Description": "ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product containing aripiprazole, an atypical antipsychotic, embedded with an Ingestible Event Marker (IEM) sensor. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY MYCITE is available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strength tablets with sensor. Inactive ingredients of the tablets with sensor include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. Ingredients of the IEM include aluminum, cuprous chloride, ethyl cellulose, gold, hydroxypropyl cellulose, magnesium, silicon, silicon dioxide, silicon nitride, titanium-tungsten, titanium and triethyl citrate. The ABILIFY MYCITE System is a drug-device combination product composed of the following components: 1 An aripiprazole tablet with an embedded Ingestible Event Marker (IEM) sensor. The IEM is a 1 mm sized sensor embedded in the ABILIFY MYCITE tablets with sensor. Upon contact with gastric fluid, magnesium and cuprous chloride within the IEM react to activate and power the device. The IEM then communicates to the MYCITE Patch, to track aripiprazole ingestion., 2 A MYCITE Patch (wearable sensor) is designed to detect the ingestion of the ABILIFY MYCITE tablets with sensor, record the ingestion of the IEM, and transmit ingestion data to the mobile patient application (app)., 3 A compatible app displays this data to allow patients to review their medication ingestion. These data can be shared with healthcare providers and caregivers., 4 Web-based portal or dashboard for healthcare professionals and caregivers."
},
{
"NDCCode": "59148-002-16",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (59148-002-16)",
"NDC11Code": "59148-0002-16",
"ProductNDC": "59148-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pletal",
"NonProprietaryName": "Cilostazol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990115",
"EndMarketingDate": "20160630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020863",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "CILOSTAZOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "59148-003-16",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (59148-003-16)",
"NDC11Code": "59148-0003-16",
"ProductNDC": "59148-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pletal",
"NonProprietaryName": "Cilostazol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990115",
"EndMarketingDate": "20171130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020863",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "CILOSTAZOL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "59148-006-13",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59148-006-13) ",
"NDC11Code": "59148-0006-13",
"ProductNDC": "59148-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021115",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "59148-006-92",
"PackageDescription": "7 TABLET in 1 BLISTER PACK (59148-006-92) ",
"NDC11Code": "59148-0006-92",
"ProductNDC": "59148-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021115",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "59148-007-13",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59148-007-13) ",
"NDC11Code": "59148-0007-13",
"ProductNDC": "59148-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021115",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "59148-007-35",
"PackageDescription": "100 TABLET in 1 BLISTER PACK (59148-007-35) ",
"NDC11Code": "59148-0007-35",
"ProductNDC": "59148-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021115",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "59148-007-94",
"PackageDescription": "7 TABLET in 1 BLISTER PACK (59148-007-94) ",
"NDC11Code": "59148-0007-94",
"ProductNDC": "59148-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021115",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "59148-008-13",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59148-008-13) ",
"NDC11Code": "59148-0008-13",
"ProductNDC": "59148-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021115",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "59148-008-35",
"PackageDescription": "100 TABLET in 1 BLISTER PACK (59148-008-35) ",
"NDC11Code": "59148-0008-35",
"ProductNDC": "59148-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021115",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "59148-008-95",
"PackageDescription": "7 TABLET in 1 BLISTER PACK (59148-008-95) ",
"NDC11Code": "59148-0008-95",
"ProductNDC": "59148-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021115",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "59148-009-13",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59148-009-13) ",
"NDC11Code": "59148-0009-13",
"ProductNDC": "59148-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021115",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "59148-009-35",
"PackageDescription": "100 TABLET in 1 BLISTER PACK (59148-009-35) ",
"NDC11Code": "59148-0009-35",
"ProductNDC": "59148-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021115",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "59148-009-95",
"PackageDescription": "7 TABLET in 1 BLISTER PACK (59148-009-95) ",
"NDC11Code": "59148-0009-95",
"ProductNDC": "59148-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021115",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "59148-010-13",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59148-010-13) ",
"NDC11Code": "59148-0010-13",
"ProductNDC": "59148-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021115",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "59148-010-35",
"PackageDescription": "100 TABLET in 1 BLISTER PACK (59148-010-35) ",
"NDC11Code": "59148-0010-35",
"ProductNDC": "59148-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
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"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "59148-011-13",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59148-011-13) ",
"NDC11Code": "59148-0011-13",
"ProductNDC": "59148-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021115",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "59148-011-35",
"PackageDescription": "100 TABLET in 1 BLISTER PACK (59148-011-35) ",
"NDC11Code": "59148-0011-35",
"ProductNDC": "59148-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021115",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.",
"Description": "Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "59148-013-15",
"PackageDescription": "150 mL in 1 BOTTLE (59148-013-15) ",
"NDC11Code": "59148-0013-15",
"ProductNDC": "59148-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20041210",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021713",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20041210",
"SamplePackage": "N"
},
{
"NDCCode": "59148-016-65",
"PackageDescription": "1.3 mL in 1 VIAL (59148-016-65) ",
"NDC11Code": "59148-0016-65",
"ProductNDC": "59148-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20060920",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021866",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "9.75",
"StrengthUnit": "mg/1.3mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20060920",
"SamplePackage": "N"
},
{
"NDCCode": "59148-018-71",
"PackageDescription": "1 KIT in 1 CARTON (59148-018-71) * 1.5 mL in 1 VIAL, SINGLE-USE * 5 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "59148-0018-71",
"ProductNDC": "59148-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify Maintena",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "KIT",
"StartMarketingDate": "20130228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202971",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"Status": "Deprecated",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130928",
"SamplePackage": "N",
"IndicationAndUsage": "ABILIFY MAINTENA (aripiprazole) is indicated: 1 for the treatment of schizophrenia in adults, 2 for maintenance monotherapy treatment of bipolar I disorder in adults.",
"Description": "Aripiprazole is an atypical antipsychotic which is present in ABILIFY MAINTENA as its monohydrate polymorphic form. Aripiprazole monohydrate is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl] butoxy]-3,4 dihydrocarbostyril monohydrate. The empirical formula is C23H27Cl2N3O2∙H2O and its molecular weight is 466.40. The chemical structure is. ABILIFY MAINTENA (aripiprazole) is an extended-release injectable suspension available in 400 mg or 300 mg strength pre-filled dual chamber syringes and 400 mg or 300 mg strength vials. The labeled strengths are calculated based on the anhydrous form (aripiprazole). Inactive ingredients (per administered dose) for 400 mg and 300 mg strength products, respectively, include carboxymethyl cellulose sodium (16.64 mg and 12.48 mg), mannitol (83.2 mg and 62.4 mg), sodium phosphate monobasic monohydrate (1.48 mg and 1.11 mg) and sodium hydroxide (pH adjuster)."
}
]
}
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<NDCList>
<NDC>
<NDCCode>59148-034-61</NDCCode>
<PackageDescription>1 BOTTLE in 1 KIT (59148-034-61) / 30 TABLET WITH SENSOR in 1 BOTTLE (59148-034-13) </PackageDescription>
<NDC11Code>59148-0034-61</NDC11Code>
<ProductNDC>59148-034</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abilify Mycite</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET WITH SENSOR</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180131</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207202</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
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<Status>Deprecated</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the: 1 Treatment of adults with schizophrenia., 2 Treatment of bipolar I disorderAcute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate.Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate., 3 Adjunctive treatment of adults with Major Depressive Disorder. .</IndicationAndUsage>
<Description>ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product containing aripiprazole, an atypical antipsychotic, embedded with an Ingestible Event Marker (IEM) sensor. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY MYCITE is available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strength tablets with sensor. Inactive ingredients of the tablets with sensor include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. Ingredients of the IEM include aluminum, cuprous chloride, ethyl cellulose, gold, hydroxypropyl cellulose, magnesium, silicon, silicon dioxide, silicon nitride, titanium-tungsten, titanium and triethyl citrate. The ABILIFY MYCITE System is a drug-device combination product composed of the following components: 1 An aripiprazole tablet with an embedded Ingestible Event Marker (IEM) sensor. The IEM is a 1 mm sized sensor embedded in the ABILIFY MYCITE tablets with sensor. Upon contact with gastric fluid, magnesium and cuprous chloride within the IEM react to activate and power the device. The IEM then communicates to the MYCITE Patch, to track aripiprazole ingestion., 2 A MYCITE Patch (wearable sensor) is designed to detect the ingestion of the ABILIFY MYCITE tablets with sensor, record the ingestion of the IEM, and transmit ingestion data to the mobile patient application (app)., 3 A compatible app displays this data to allow patients to review their medication ingestion. These data can be shared with healthcare providers and caregivers., 4 Web-based portal or dashboard for healthcare professionals and caregivers.</Description>
</NDC>
<NDC>
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<PackageDescription>1 TUBE in 1 CARTON (82761-034-61) / 25 mL in 1 TUBE</PackageDescription>
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<ProductNDC>82761-034</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laura Mercier Tinted Moisturizer Oil Free Natural Skin Perfector Broad Spectrum Spf 20 Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>6w1 Ganache</ProprietaryNameSuffix>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59148-034-72</NDCCode>
<PackageDescription>1 BOTTLE in 1 KIT (59148-034-72) / 30 TABLET WITH SENSOR in 1 BOTTLE (59148-034-13) </PackageDescription>
<NDC11Code>59148-0034-72</NDC11Code>
<ProductNDC>59148-034</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abilify Mycite</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET WITH SENSOR</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207202</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the: 1 Treatment of adults with schizophrenia., 2 Treatment of bipolar I disorderAcute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate.Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate., 3 Adjunctive treatment of adults with Major Depressive Disorder. .</IndicationAndUsage>
<Description>ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product containing aripiprazole, an atypical antipsychotic, embedded with an Ingestible Event Marker (IEM) sensor. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY MYCITE is available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strength tablets with sensor. Inactive ingredients of the tablets with sensor include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. Ingredients of the IEM include aluminum, cuprous chloride, ethyl cellulose, gold, hydroxypropyl cellulose, magnesium, silicon, silicon dioxide, silicon nitride, titanium-tungsten, titanium and triethyl citrate. The ABILIFY MYCITE System is a drug-device combination product composed of the following components: 1 An aripiprazole tablet with an embedded Ingestible Event Marker (IEM) sensor. The IEM is a 1 mm sized sensor embedded in the ABILIFY MYCITE tablets with sensor. Upon contact with gastric fluid, magnesium and cuprous chloride within the IEM react to activate and power the device. The IEM then communicates to the MYCITE Patch, to track aripiprazole ingestion., 2 A MYCITE Patch (wearable sensor) is designed to detect the ingestion of the ABILIFY MYCITE tablets with sensor, record the ingestion of the IEM, and transmit ingestion data to the mobile patient application (app)., 3 A compatible app displays this data to allow patients to review their medication ingestion. These data can be shared with healthcare providers and caregivers., 4 Web-based portal or dashboard for healthcare professionals and caregivers.</Description>
</NDC>
<NDC>
<NDCCode>59148-034-85</NDCCode>
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<NDC11Code>59148-0034-85</NDC11Code>
<ProductNDC>59148-034</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abilify Mycite</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET WITH SENSOR</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180131</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207202</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59148-034-90</NDCCode>
<PackageDescription>1 BOTTLE in 1 KIT (59148-034-90) / 7 TABLET WITH SENSOR in 1 BOTTLE (59148-034-07) </PackageDescription>
<NDC11Code>59148-0034-90</NDC11Code>
<ProductNDC>59148-034</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abilify Mycite</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET WITH SENSOR</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180131</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207202</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the: 1 Treatment of adults with schizophrenia., 2 Treatment of bipolar I disorderAcute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate.Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate., 3 Adjunctive treatment of adults with Major Depressive Disorder. .</IndicationAndUsage>
<Description>ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product containing aripiprazole, an atypical antipsychotic, embedded with an Ingestible Event Marker (IEM) sensor. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY MYCITE is available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strength tablets with sensor. Inactive ingredients of the tablets with sensor include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. Ingredients of the IEM include aluminum, cuprous chloride, ethyl cellulose, gold, hydroxypropyl cellulose, magnesium, silicon, silicon dioxide, silicon nitride, titanium-tungsten, titanium and triethyl citrate. The ABILIFY MYCITE System is a drug-device combination product composed of the following components: 1 An aripiprazole tablet with an embedded Ingestible Event Marker (IEM) sensor. The IEM is a 1 mm sized sensor embedded in the ABILIFY MYCITE tablets with sensor. Upon contact with gastric fluid, magnesium and cuprous chloride within the IEM react to activate and power the device. The IEM then communicates to the MYCITE Patch, to track aripiprazole ingestion., 2 A MYCITE Patch (wearable sensor) is designed to detect the ingestion of the ABILIFY MYCITE tablets with sensor, record the ingestion of the IEM, and transmit ingestion data to the mobile patient application (app)., 3 A compatible app displays this data to allow patients to review their medication ingestion. These data can be shared with healthcare providers and caregivers., 4 Web-based portal or dashboard for healthcare professionals and caregivers.</Description>
</NDC>
<NDC>
<NDCCode>59148-029-61</NDCCode>
<PackageDescription>1 BOTTLE in 1 KIT (59148-029-61) / 30 TABLET WITH SENSOR in 1 BOTTLE (59148-029-13) </PackageDescription>
<NDC11Code>59148-0029-61</NDC11Code>
<ProductNDC>59148-029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abilify Mycite</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET WITH SENSOR</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180131</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207202</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the: 1 Treatment of adults with schizophrenia., 2 Treatment of bipolar I disorderAcute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate.Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate., 3 Adjunctive treatment of adults with Major Depressive Disorder. .</IndicationAndUsage>
<Description>ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product containing aripiprazole, an atypical antipsychotic, embedded with an Ingestible Event Marker (IEM) sensor. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY MYCITE is available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strength tablets with sensor. Inactive ingredients of the tablets with sensor include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. Ingredients of the IEM include aluminum, cuprous chloride, ethyl cellulose, gold, hydroxypropyl cellulose, magnesium, silicon, silicon dioxide, silicon nitride, titanium-tungsten, titanium and triethyl citrate. The ABILIFY MYCITE System is a drug-device combination product composed of the following components: 1 An aripiprazole tablet with an embedded Ingestible Event Marker (IEM) sensor. The IEM is a 1 mm sized sensor embedded in the ABILIFY MYCITE tablets with sensor. Upon contact with gastric fluid, magnesium and cuprous chloride within the IEM react to activate and power the device. The IEM then communicates to the MYCITE Patch, to track aripiprazole ingestion., 2 A MYCITE Patch (wearable sensor) is designed to detect the ingestion of the ABILIFY MYCITE tablets with sensor, record the ingestion of the IEM, and transmit ingestion data to the mobile patient application (app)., 3 A compatible app displays this data to allow patients to review their medication ingestion. These data can be shared with healthcare providers and caregivers., 4 Web-based portal or dashboard for healthcare professionals and caregivers.</Description>
</NDC>
<NDC>
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<PackageDescription>1 BOTTLE in 1 KIT (59148-030-61) / 30 TABLET WITH SENSOR in 1 BOTTLE (59148-030-13) </PackageDescription>
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<StartMarketingDate>20180131</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207202</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
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<Status>Deprecated</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the: 1 Treatment of adults with schizophrenia., 2 Treatment of bipolar I disorderAcute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate.Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate., 3 Adjunctive treatment of adults with Major Depressive Disorder. .</IndicationAndUsage>
<Description>ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product containing aripiprazole, an atypical antipsychotic, embedded with an Ingestible Event Marker (IEM) sensor. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY MYCITE is available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strength tablets with sensor. Inactive ingredients of the tablets with sensor include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. Ingredients of the IEM include aluminum, cuprous chloride, ethyl cellulose, gold, hydroxypropyl cellulose, magnesium, silicon, silicon dioxide, silicon nitride, titanium-tungsten, titanium and triethyl citrate. The ABILIFY MYCITE System is a drug-device combination product composed of the following components: 1 An aripiprazole tablet with an embedded Ingestible Event Marker (IEM) sensor. The IEM is a 1 mm sized sensor embedded in the ABILIFY MYCITE tablets with sensor. Upon contact with gastric fluid, magnesium and cuprous chloride within the IEM react to activate and power the device. The IEM then communicates to the MYCITE Patch, to track aripiprazole ingestion., 2 A MYCITE Patch (wearable sensor) is designed to detect the ingestion of the ABILIFY MYCITE tablets with sensor, record the ingestion of the IEM, and transmit ingestion data to the mobile patient application (app)., 3 A compatible app displays this data to allow patients to review their medication ingestion. These data can be shared with healthcare providers and caregivers., 4 Web-based portal or dashboard for healthcare professionals and caregivers.</Description>
</NDC>
<NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20180131</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207202</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the: 1 Treatment of adults with schizophrenia., 2 Treatment of bipolar I disorderAcute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate.Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate., 3 Adjunctive treatment of adults with Major Depressive Disorder. .</IndicationAndUsage>
<Description>ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product containing aripiprazole, an atypical antipsychotic, embedded with an Ingestible Event Marker (IEM) sensor. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY MYCITE is available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strength tablets with sensor. Inactive ingredients of the tablets with sensor include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. Ingredients of the IEM include aluminum, cuprous chloride, ethyl cellulose, gold, hydroxypropyl cellulose, magnesium, silicon, silicon dioxide, silicon nitride, titanium-tungsten, titanium and triethyl citrate. The ABILIFY MYCITE System is a drug-device combination product composed of the following components: 1 An aripiprazole tablet with an embedded Ingestible Event Marker (IEM) sensor. The IEM is a 1 mm sized sensor embedded in the ABILIFY MYCITE tablets with sensor. Upon contact with gastric fluid, magnesium and cuprous chloride within the IEM react to activate and power the device. The IEM then communicates to the MYCITE Patch, to track aripiprazole ingestion., 2 A MYCITE Patch (wearable sensor) is designed to detect the ingestion of the ABILIFY MYCITE tablets with sensor, record the ingestion of the IEM, and transmit ingestion data to the mobile patient application (app)., 3 A compatible app displays this data to allow patients to review their medication ingestion. These data can be shared with healthcare providers and caregivers., 4 Web-based portal or dashboard for healthcare professionals and caregivers.</Description>
</NDC>
<NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207202</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the: 1 Treatment of adults with schizophrenia., 2 Treatment of bipolar I disorderAcute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate.Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate., 3 Adjunctive treatment of adults with Major Depressive Disorder. .</IndicationAndUsage>
<Description>ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product containing aripiprazole, an atypical antipsychotic, embedded with an Ingestible Event Marker (IEM) sensor. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY MYCITE is available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strength tablets with sensor. Inactive ingredients of the tablets with sensor include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. Ingredients of the IEM include aluminum, cuprous chloride, ethyl cellulose, gold, hydroxypropyl cellulose, magnesium, silicon, silicon dioxide, silicon nitride, titanium-tungsten, titanium and triethyl citrate. The ABILIFY MYCITE System is a drug-device combination product composed of the following components: 1 An aripiprazole tablet with an embedded Ingestible Event Marker (IEM) sensor. The IEM is a 1 mm sized sensor embedded in the ABILIFY MYCITE tablets with sensor. Upon contact with gastric fluid, magnesium and cuprous chloride within the IEM react to activate and power the device. The IEM then communicates to the MYCITE Patch, to track aripiprazole ingestion., 2 A MYCITE Patch (wearable sensor) is designed to detect the ingestion of the ABILIFY MYCITE tablets with sensor, record the ingestion of the IEM, and transmit ingestion data to the mobile patient application (app)., 3 A compatible app displays this data to allow patients to review their medication ingestion. These data can be shared with healthcare providers and caregivers., 4 Web-based portal or dashboard for healthcare professionals and caregivers.</Description>
</NDC>
<NDC>
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<NDC11Code>59148-0033-61</NDC11Code>
<ProductNDC>59148-033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abilify Mycite</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET WITH SENSOR</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180131</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207202</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the: 1 Treatment of adults with schizophrenia., 2 Treatment of bipolar I disorderAcute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate.Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate., 3 Adjunctive treatment of adults with Major Depressive Disorder. .</IndicationAndUsage>
<Description>ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product containing aripiprazole, an atypical antipsychotic, embedded with an Ingestible Event Marker (IEM) sensor. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY MYCITE is available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strength tablets with sensor. Inactive ingredients of the tablets with sensor include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. Ingredients of the IEM include aluminum, cuprous chloride, ethyl cellulose, gold, hydroxypropyl cellulose, magnesium, silicon, silicon dioxide, silicon nitride, titanium-tungsten, titanium and triethyl citrate. The ABILIFY MYCITE System is a drug-device combination product composed of the following components: 1 An aripiprazole tablet with an embedded Ingestible Event Marker (IEM) sensor. The IEM is a 1 mm sized sensor embedded in the ABILIFY MYCITE tablets with sensor. Upon contact with gastric fluid, magnesium and cuprous chloride within the IEM react to activate and power the device. The IEM then communicates to the MYCITE Patch, to track aripiprazole ingestion., 2 A MYCITE Patch (wearable sensor) is designed to detect the ingestion of the ABILIFY MYCITE tablets with sensor, record the ingestion of the IEM, and transmit ingestion data to the mobile patient application (app)., 3 A compatible app displays this data to allow patients to review their medication ingestion. These data can be shared with healthcare providers and caregivers., 4 Web-based portal or dashboard for healthcare professionals and caregivers.</Description>
</NDC>
<NDC>
<NDCCode>59148-002-16</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (59148-002-16)</PackageDescription>
<NDC11Code>59148-0002-16</NDC11Code>
<ProductNDC>59148-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pletal</ProprietaryName>
<NonProprietaryName>Cilostazol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990115</StartMarketingDate>
<EndMarketingDate>20160630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020863</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>CILOSTAZOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>59148-003-16</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (59148-003-16)</PackageDescription>
<NDC11Code>59148-0003-16</NDC11Code>
<ProductNDC>59148-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pletal</ProprietaryName>
<NonProprietaryName>Cilostazol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990115</StartMarketingDate>
<EndMarketingDate>20171130</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020863</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>CILOSTAZOL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>59148-006-13</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59148-006-13) </PackageDescription>
<NDC11Code>59148-0006-13</NDC11Code>
<ProductNDC>59148-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abilify</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021436</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>59148-006-92</NDCCode>
<PackageDescription>7 TABLET in 1 BLISTER PACK (59148-006-92) </PackageDescription>
<NDC11Code>59148-0006-92</NDC11Code>
<ProductNDC>59148-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abilify</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021436</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>59148-007-13</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59148-007-13) </PackageDescription>
<NDC11Code>59148-0007-13</NDC11Code>
<ProductNDC>59148-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021436</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>59148-007-35</NDCCode>
<PackageDescription>100 TABLET in 1 BLISTER PACK (59148-007-35) </PackageDescription>
<NDC11Code>59148-0007-35</NDC11Code>
<ProductNDC>59148-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abilify</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021436</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021115</StartMarketingDatePackage>
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<IndicationAndUsage>ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.</Description>
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<IndicationAndUsage>ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.</Description>
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<IndicationAndUsage>ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.</Description>
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<IndicationAndUsage>ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.</Description>
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<IndicationAndUsage>ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.</Description>
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<IndicationAndUsage>ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.</Description>
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<IndicationAndUsage>ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.</Description>
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<IndicationAndUsage>ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.</Description>
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<IndicationAndUsage>ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.</Description>
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<IndicationAndUsage>ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.</Description>
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<IndicationAndUsage>ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.</Description>
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<IndicationAndUsage>ABILIFY (aripiprazole) Tablets are indicated for the treatment of: 1 Schizophrenia, 2 Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, 3 Adjunctive Treatment of Major Depressive Disorder, 4 Irritability Associated with Autistic Disorder, 5 Treatment of Tourette's Disorder.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic drug that is available as ABILIFY® (aripiprazole) Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.</Description>
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<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041210</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021713</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20041210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59148-016-65</NDCCode>
<PackageDescription>1.3 mL in 1 VIAL (59148-016-65) </PackageDescription>
<NDC11Code>59148-0016-65</NDC11Code>
<ProductNDC>59148-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abilify</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20060920</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021866</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>9.75</StrengthNumber>
<StrengthUnit>mg/1.3mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59148-018-71</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (59148-018-71) * 1.5 mL in 1 VIAL, SINGLE-USE * 5 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>59148-0018-71</NDC11Code>
<ProductNDC>59148-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abilify Maintena</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130228</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202971</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABILIFY MAINTENA (aripiprazole) is indicated: 1 for the treatment of schizophrenia in adults, 2 for maintenance monotherapy treatment of bipolar I disorder in adults.</IndicationAndUsage>
<Description>Aripiprazole is an atypical antipsychotic which is present in ABILIFY MAINTENA as its monohydrate polymorphic form. Aripiprazole monohydrate is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl] butoxy]-3,4 dihydrocarbostyril monohydrate. The empirical formula is C23H27Cl2N3O2∙H2O and its molecular weight is 466.40. The chemical structure is. ABILIFY MAINTENA (aripiprazole) is an extended-release injectable suspension available in 400 mg or 300 mg strength pre-filled dual chamber syringes and 400 mg or 300 mg strength vials. The labeled strengths are calculated based on the anhydrous form (aripiprazole). Inactive ingredients (per administered dose) for 400 mg and 300 mg strength products, respectively, include carboxymethyl cellulose sodium (16.64 mg and 12.48 mg), mannitol (83.2 mg and 62.4 mg), sodium phosphate monobasic monohydrate (1.48 mg and 1.11 mg) and sodium hydroxide (pH adjuster).</Description>
</NDC>
</NDCList>