{
"NDC": [
{
"NDCCode": "59148-031-90",
"PackageDescription": "1 BOTTLE in 1 KIT (59148-031-90) / 7 TABLET WITH SENSOR in 1 BOTTLE (59148-031-07) ",
"NDC11Code": "59148-0031-90",
"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]",
"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": "59148-031-61",
"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]",
"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": "59148-031-72",
"PackageDescription": "1 BOTTLE in 1 KIT (59148-031-72) / 30 TABLET WITH SENSOR in 1 BOTTLE (59148-031-13) ",
"NDC11Code": "59148-0031-72",
"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]",
"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": "59148-031-85",
"PackageDescription": "1 BOTTLE in 1 KIT (59148-031-85) > 30 TABLET WITH SENSOR in 1 BOTTLE (59148-031-13) ",
"NDC11Code": "59148-0031-85",
"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]",
"Status": "Deprecated",
"LastUpdate": "2023-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180131",
"SamplePackage": "N"
},
{
"NDCCode": "59148-029-90",
"PackageDescription": "1 BOTTLE in 1 KIT (59148-029-90) / 7 TABLET WITH SENSOR in 1 BOTTLE (59148-029-07) ",
"NDC11Code": "59148-0029-90",
"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": "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": "59148-030-90",
"PackageDescription": "1 BOTTLE in 1 KIT (59148-030-90) / 7 TABLET WITH SENSOR in 1 BOTTLE (59148-030-07) ",
"NDC11Code": "59148-0030-90",
"ProductNDC": "59148-030",
"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": "5",
"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": "59148-032-90",
"PackageDescription": "1 BOTTLE in 1 KIT (59148-032-90) / 7 TABLET WITH SENSOR in 1 BOTTLE (59148-032-07) ",
"NDC11Code": "59148-0032-90",
"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",
"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": "59148-033-90",
"PackageDescription": "1 BOTTLE in 1 KIT (59148-033-90) / 7 TABLET WITH SENSOR in 1 BOTTLE (59148-033-07) ",
"NDC11Code": "59148-0033-90",
"ProductNDC": "59148-033",
"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": "20",
"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": "59148-034-90",
"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": "59148-047-91",
"PackageDescription": "8 VIAL in 1 PACKAGE (59148-047-91) > 10 mL in 1 VIAL (59148-047-90) ",
"NDC11Code": "59148-0047-91",
"ProductNDC": "59148-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Busulfex",
"NonProprietaryName": "Busulfan",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150213",
"EndMarketingDate": "20210131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020954",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "BUSULFAN",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Alkylating Activity [MoA],Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150213",
"EndMarketingDatePackage": "20210131",
"SamplePackage": "N"
},
{
"NDCCode": "59148-070-91",
"PackageDescription": "8 CARTON in 1 CARTON (59148-070-91) / 1 VIAL in 1 CARTON (59148-070-90) / 10 mL in 1 VIAL",
"NDC11Code": "59148-0070-91",
"ProductNDC": "59148-070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Busulfex",
"NonProprietaryName": "Busulfan",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19990204",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020954",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "BUSULFAN",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19990204",
"SamplePackage": "N",
"IndicationAndUsage": "BUSULFEX is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.",
"Description": "Busulfan is a bifunctional alkylating agent known chemically as 1,4-butanediol, dimethanesulfonate. The molecular formula of busulfan is CH3SO2O(CH2)4OSO2CH3 with a molecular weight of 246 g/mole. Busulfan has the following chemical structure. BUSULFEX (busulfan) Injection is supplied as a clear, colorless, sterile, solution in 10 mL single-dose vials for intravenous administration upon dilution. Each vial contains 60 mg of busulfan in N,N-dimethylacetamide (DMA), 3.3 mL and Polyethylene Glycol 400, NF 6.7 mL. The solubility of busulfan in water is 0.1 g per L and the pH of BUSULFEX diluted to approximately 0.5 mg per mL busulfan in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP as recommended for infusion reflects the pH of the diluent used and ranges from 3.4 to 3.9."
},
{
"NDCCode": "59148-245-12",
"PackageDescription": "1 KIT in 1 CARTON (59148-245-12) * 1.9 mL in 1 VIAL, SINGLE-USE (59148-238-90) * 2.5 mL in 1 VIAL, SINGLE-USE (59148-100-12) ",
"NDC11Code": "59148-0245-12",
"ProductNDC": "59148-245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify Maintena",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "KIT",
"StartMarketingDate": "20250228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202971",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250228",
"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)."
},
{
"NDCCode": "10544-031-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (10544-031-90)",
"NDC11Code": "10544-0031-90",
"ProductNDC": "10544-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076900",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Atenolol is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol may be administered with other antihypertensive agents.",
"Description": "Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor-blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy-3'-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are. Atenolol, USP has a molecular weight of 266. It is a white or almost white powder, sparingly soluble in water; soluble in absolute alcohol and practically insoluble in ether. Atenolol tablets, for oral administration, are available as 25 mg, 50 mg and 100 mg tablets. Inactive Ingredients: Citric acid (anhydrous), colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone."
},
{
"NDCCode": "10578-031-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (10578-031-90)",
"NDC11Code": "10578-0031-90",
"ProductNDC": "10578-031",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Homeopathic Fatigue Formula",
"NonProprietaryName": "Leopards Bane, Oat Straw, St Ignatius Bean, Phosphoric Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131001",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Indiana Botanic Gardens",
"SubstanceName": "ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; STRYCHNOS IGNATII SEED; PHOSPHORIC ACID",
"StrengthNumber": "30; 30; 30; 30",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Feelings of fatigue, listlessness, overworked."
},
{
"NDCCode": "13107-031-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (13107-031-90) ",
"NDC11Code": "13107-0031-90",
"ProductNDC": "13107-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076921",
"LabelerName": "Aurolife Pharma LLC",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090817",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Mirtazapine tablets, USP contain mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine USP, and unscored film-coated tablets containing 7.5 or 45 mg of mirtazapine USP. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, and titanium dioxide. In addition, the 15 mg contains iron oxide yellow and 30 mg contains iron oxide red, iron oxide black, and iron oxide yellow."
},
{
"NDCCode": "13548-031-90",
"PackageDescription": "90 g in 1 TUBE (13548-031-90)",
"NDC11Code": "13548-0031-90",
"ProductNDC": "13548-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cloderm",
"NonProprietaryName": "Clocortolone Pivalate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19770822",
"EndMarketingDate": "20160501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017765",
"LabelerName": "Coria Laboratories",
"SubstanceName": "CLOCORTOLONE PIVALATE",
"StrengthNumber": ".001",
"StrengthUnit": "g/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "16714-031-03",
"PackageDescription": "90 TABLET in 1 BOTTLE (16714-031-03)",
"NDC11Code": "16714-0031-03",
"ProductNDC": "16714-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078254",
"LabelerName": "Northstar RxLLC",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-12-11"
},
{
"NDCCode": "16714-031-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (16714-031-09)",
"NDC11Code": "16714-0031-09",
"ProductNDC": "16714-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078254",
"LabelerName": "Northstar RxLLC",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-12-11"
},
{
"NDCCode": "21695-031-90",
"PackageDescription": "90 BOTTLE in 1 BOTTLE (21695-031-90) > 60 TABLET, FILM COATED in 1 BOTTLE (21695-031-60)",
"NDC11Code": "21695-0031-90",
"ProductNDC": "21695-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078216",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Citalopram HBr is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram HBr is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram HBr occurs as a fine, white to off-white powder.Citalopram HBr is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available as tablets. Citalopram hydrobromide 10 mg tablets are film-coated, round shaped tablets containing citalopram HBr in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram HBr in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch, croscarmellose sodium, copovidone, magnesium stearate, hypromellose, titanium dioxide, ferric oxide red, ferric oxide yellow, glycerin, and polyethylene glycol."
},
{
"NDCCode": "27808-031-01",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (27808-031-01)",
"NDC11Code": "27808-0031-01",
"ProductNDC": "27808-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nexiclon Xr",
"NonProprietaryName": "Clonidine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101217",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022500",
"LabelerName": "Tris Pharma, Inc.",
"SubstanceName": "CLONIDINE",
"StrengthNumber": ".26",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "33342-031-10",
"PackageDescription": "90 TABLET in 1 BOTTLE (33342-031-10) ",
"NDC11Code": "33342-0031-10",
"ProductNDC": "33342-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pramipexole Dihydrochloride",
"NonProprietaryName": "Pramipexole Dihydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202164",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120921",
"SamplePackage": "N",
"IndicationAndUsage": "Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of. · Parkinson’s disease (PD) (1.1) Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).",
"Description": "Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S2HClH2O, and its molecular weight is 302.26. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.25 mg: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.5 mg: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1 mg tablets: Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1.5 mg tablets: Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride.Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, pregelatinized starch, colloidal silicon dioxide, povidone, and magnesium stearate."
},
{
"NDCCode": "37808-031-90",
"PackageDescription": "500 TABLET in 1 BOTTLE (37808-031-90)",
"NDC11Code": "37808-0031-90",
"ProductNDC": "37808-031",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19910915",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "H E B",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-01-10"
},
{
"NDCCode": "43353-031-60",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-031-60)",
"NDC11Code": "43353-0031-60",
"ProductNDC": "43353-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Crestor",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030818",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021366",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "CRESTOR is an HMG Co‑A reductase inhibitor indicated for: 1 patients with primary hyperlipidemia and mixed dyslipidemia as an adjunct to diet to reduce elevated total‑C, LDL‑C, ApoB, nonHDL‑C, and TG levels and to increase HDL‑C (1.1), 2 patients with hypertriglyceridemia as an adjunct to diet (1.2), 3 patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.3), 4 patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL‑C, total-C, and ApoB (1.4), 5 slowing the progression of atherosclerosis as part of a treatment strategy to lower total‑C and LDL‑C as an adjunct to diet (1.5), 6 pediatric patients 10 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total‑C, LDL‑C and ApoB after failing an adequate trial of diet therapy (1.1), 7 risk reduction of MI, stroke, and arterial revascularization procedures in patients without clinically evident CHD, but with multiple risk factors (1.6).",
"Description": "CRESTOR (rosuvastatin calcium) is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. CRESTOR Tablets for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: microcrystalline cellulose NF, lactose monohydrate NF, tribasic calcium phosphate NF, crospovidone NF, magnesium stearate NF, hypromellose NF, triacetin NF, titanium dioxide USP, yellow ferric oxide, and red ferric oxide NF."
},
{
"NDCCode": "47335-031-81",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-031-81) ",
"NDC11Code": "47335-0031-81",
"ProductNDC": "47335-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205905",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "7",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130614",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride extended-release capsules are orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended-release pellets with the labeled amount of memantine hydrochloride and the following inactive ingredients: sugar spheres, talc, hypromellose, polyethylene glycol, methyl cellulose, polysorbate 80, ethyl cellulose and triethyl citrate. The capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, iron oxide yellow (7 mg, 14 mg), FD&C Blue #1 (14 mg, 21 mg, 28 mg), FD&C yellow #6 (14 mg, 21 mg, 28 mg) and D&C yellow #10 (14 mg, 21 mg, 28 mg). The imprinting ink contains shellac, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "52343-031-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (52343-031-90) ",
"NDC11Code": "52343-0031-90",
"ProductNDC": "52343-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080131",
"EndMarketingDate": "20200901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078787",
"LabelerName": "ACETRIS HEALTH, LLC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20080131",
"EndMarketingDatePackage": "20200901",
"SamplePackage": "N"
},
{
"NDCCode": "54304-031-02",
"PackageDescription": "90 mL in 1 BOTTLE, PLASTIC (54304-031-02) ",
"NDC11Code": "54304-0031-02",
"ProductNDC": "54304-031",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wish/ Wish Ultra Slim Hand Sanitizer",
"ProprietaryNameSuffix": "01",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200425",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zhejiang Meizhiyuan Cosmetics Co., Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70.4",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200425",
"SamplePackage": "N"
},
{
"NDCCode": "60429-031-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (60429-031-90)",
"NDC11Code": "60429-0031-90",
"ProductNDC": "60429-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Captopril",
"NonProprietaryName": "Captopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074505",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "CAPTOPRIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
},
{
"NDCCode": "60763-031-11",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (60763-031-11) ",
"NDC11Code": "60763-0031-11",
"ProductNDC": "60763-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pitavastatin",
"NonProprietaryName": "Pitavastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205955",
"LabelerName": "STASON PHARMACEUTICALS, INC.",
"SubstanceName": "PITAVASTATIN CALCIUM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "20171225",
"SamplePackage": "N"
},
{
"NDCCode": "63187-031-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (63187-031-90) ",
"NDC11Code": "63187-0031-90",
"ProductNDC": "63187-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090705",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-05-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Postherpetic Neuralgia. Gabapentin is indicated for the management of postherpetic neuralgia in adults. Epilepsy. Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 – 12 years.",
"Description": "Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. Gabapentin, USP is described as 1-(aminomethyl) cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24. The structural formula of gabapentin is. C9H17NO2 M.W. 171.24. C9H17NO2 M.W. 171.24. C9H17NO2 M.W. 171.24. C9H17NO2 M.W. 171.24. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25."
},
{
"NDCCode": "65162-031-09",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (65162-031-09) ",
"NDC11Code": "65162-0031-09",
"ProductNDC": "65162-031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pitavastatin",
"NonProprietaryName": "Pitavastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240821",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205961",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "PITAVASTATIN CALCIUM",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240821",
"SamplePackage": "N",
"IndicationAndUsage": "Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: : 1 Adults with primary hyperlipidemia. , 2 Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). .",
"Description": "Pitavastatin tablets for oral use is an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (+)monocalcium bis{(3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoate} pentahydrate. The structural formula is. The molecular formula for pitavastatin is C50H46CaF2N2O8 ∙5H2O and the molecular weight is 971.06 g/mol. Pitavastatin is odorless and occurs as white to off-white powder. It is freely soluble in tetrahydrofuran, soluble in ethylene glycol, sparingly soluble in dimethyl sulphoxide and in 50 % aqueous acetonitrile, slightly soluble in methanol, very slightly soluble in water and in ethanol (96%), and insoluble in diethyl ether. Pitavastatin is hygroscopic and slightly unstable in light. Each film-coated tablet of pitavastatin contains 1 mg, 2 mg, or 4 mg of pitavastatin, which is equivalent to 1.045 mg, 2.09 mg, or 4.18 mg, respectively, of pitavastatin calcium and the following inactive ingredients: hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium aluminometasilicate, and magnesium stearate. The film-coating contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, titanium dioxide, and triethyl citrate."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>59148-031-90</NDCCode>
<PackageDescription>1 BOTTLE in 1 KIT (59148-031-90) / 7 TABLET WITH SENSOR in 1 BOTTLE (59148-031-07) </PackageDescription>
<NDC11Code>59148-0031-90</NDC11Code>
<ProductNDC>59148-031</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>10</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>59148-031-61</NDCCode>
<PackageDescription>1 BOTTLE in 1 KIT (59148-031-61) / 30 TABLET WITH SENSOR in 1 BOTTLE (59148-031-13) </PackageDescription>
<NDC11Code>59148-0031-61</NDC11Code>
<ProductNDC>59148-031</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>10</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>59148-031-72</NDCCode>
<PackageDescription>1 BOTTLE in 1 KIT (59148-031-72) / 30 TABLET WITH SENSOR in 1 BOTTLE (59148-031-13) </PackageDescription>
<NDC11Code>59148-0031-72</NDC11Code>
<ProductNDC>59148-031</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>10</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>59148-031-85</NDCCode>
<PackageDescription>1 BOTTLE in 1 KIT (59148-031-85) > 30 TABLET WITH SENSOR in 1 BOTTLE (59148-031-13) </PackageDescription>
<NDC11Code>59148-0031-85</NDC11Code>
<ProductNDC>59148-031</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>10</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>59148-029-90</NDCCode>
<PackageDescription>1 BOTTLE in 1 KIT (59148-029-90) / 7 TABLET WITH SENSOR in 1 BOTTLE (59148-029-07) </PackageDescription>
<NDC11Code>59148-0029-90</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>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>59148-030-90</NDCCode>
<PackageDescription>1 BOTTLE in 1 KIT (59148-030-90) / 7 TABLET WITH SENSOR in 1 BOTTLE (59148-030-07) </PackageDescription>
<NDC11Code>59148-0030-90</NDC11Code>
<ProductNDC>59148-030</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>5</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>59148-032-90</NDCCode>
<PackageDescription>1 BOTTLE in 1 KIT (59148-032-90) / 7 TABLET WITH SENSOR in 1 BOTTLE (59148-032-07) </PackageDescription>
<NDC11Code>59148-0032-90</NDC11Code>
<ProductNDC>59148-032</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>15</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>59148-033-90</NDCCode>
<PackageDescription>1 BOTTLE in 1 KIT (59148-033-90) / 7 TABLET WITH SENSOR in 1 BOTTLE (59148-033-07) </PackageDescription>
<NDC11Code>59148-0033-90</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>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>59148-034-90</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>59148-047-91</NDCCode>
<PackageDescription>8 VIAL in 1 PACKAGE (59148-047-91) > 10 mL in 1 VIAL (59148-047-90) </PackageDescription>
<NDC11Code>59148-0047-91</NDC11Code>
<ProductNDC>59148-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Busulfex</ProprietaryName>
<NonProprietaryName>Busulfan</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150213</StartMarketingDate>
<EndMarketingDate>20210131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020954</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>BUSULFAN</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA],Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150213</StartMarketingDatePackage>
<EndMarketingDatePackage>20210131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59148-070-91</NDCCode>
<PackageDescription>8 CARTON in 1 CARTON (59148-070-91) / 1 VIAL in 1 CARTON (59148-070-90) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>59148-0070-91</NDC11Code>
<ProductNDC>59148-070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Busulfex</ProprietaryName>
<NonProprietaryName>Busulfan</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19990204</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020954</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>BUSULFAN</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BUSULFEX is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.</IndicationAndUsage>
<Description>Busulfan is a bifunctional alkylating agent known chemically as 1,4-butanediol, dimethanesulfonate. The molecular formula of busulfan is CH3SO2O(CH2)4OSO2CH3 with a molecular weight of 246 g/mole. Busulfan has the following chemical structure. BUSULFEX (busulfan) Injection is supplied as a clear, colorless, sterile, solution in 10 mL single-dose vials for intravenous administration upon dilution. Each vial contains 60 mg of busulfan in N,N-dimethylacetamide (DMA), 3.3 mL and Polyethylene Glycol 400, NF 6.7 mL. The solubility of busulfan in water is 0.1 g per L and the pH of BUSULFEX diluted to approximately 0.5 mg per mL busulfan in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP as recommended for infusion reflects the pH of the diluent used and ranges from 3.4 to 3.9.</Description>
</NDC>
<NDC>
<NDCCode>59148-245-12</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (59148-245-12) * 1.9 mL in 1 VIAL, SINGLE-USE (59148-238-90) * 2.5 mL in 1 VIAL, SINGLE-USE (59148-100-12) </PackageDescription>
<NDC11Code>59148-0245-12</NDC11Code>
<ProductNDC>59148-245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abilify Maintena</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250228</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202971</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250228</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>
<NDC>
<NDCCode>10544-031-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (10544-031-90)</PackageDescription>
<NDC11Code>10544-0031-90</NDC11Code>
<ProductNDC>10544-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076900</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atenolol is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, a synthetic, beta1-selective (cardioselective) adrenoreceptor-blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy-3'-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are. Atenolol, USP has a molecular weight of 266. It is a white or almost white powder, sparingly soluble in water; soluble in absolute alcohol and practically insoluble in ether. Atenolol tablets, for oral administration, are available as 25 mg, 50 mg and 100 mg tablets. Inactive Ingredients: Citric acid (anhydrous), colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone.</Description>
</NDC>
<NDC>
<NDCCode>10578-031-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (10578-031-90)</PackageDescription>
<NDC11Code>10578-0031-90</NDC11Code>
<ProductNDC>10578-031</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Homeopathic Fatigue Formula</ProprietaryName>
<NonProprietaryName>Leopards Bane, Oat Straw, St Ignatius Bean, Phosphoric Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Indiana Botanic Gardens</LabelerName>
<SubstanceName>ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; STRYCHNOS IGNATII SEED; PHOSPHORIC ACID</SubstanceName>
<StrengthNumber>30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Feelings of fatigue, listlessness, overworked.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13107-031-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (13107-031-90) </PackageDescription>
<NDC11Code>13107-0031-90</NDC11Code>
<ProductNDC>13107-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076921</ApplicationNumber>
<LabelerName>Aurolife Pharma LLC</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Mirtazapine tablets, USP contain mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine tablets, USP are available for oral administration as scored film-coated tablets containing 15 or 30 mg of mirtazapine USP, and unscored film-coated tablets containing 7.5 or 45 mg of mirtazapine USP. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, and titanium dioxide. In addition, the 15 mg contains iron oxide yellow and 30 mg contains iron oxide red, iron oxide black, and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>13548-031-90</NDCCode>
<PackageDescription>90 g in 1 TUBE (13548-031-90)</PackageDescription>
<NDC11Code>13548-0031-90</NDC11Code>
<ProductNDC>13548-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cloderm</ProprietaryName>
<NonProprietaryName>Clocortolone Pivalate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19770822</StartMarketingDate>
<EndMarketingDate>20160501</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017765</ApplicationNumber>
<LabelerName>Coria Laboratories</LabelerName>
<SubstanceName>CLOCORTOLONE PIVALATE</SubstanceName>
<StrengthNumber>.001</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>16714-031-03</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (16714-031-03)</PackageDescription>
<NDC11Code>16714-0031-03</NDC11Code>
<ProductNDC>16714-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078254</ApplicationNumber>
<LabelerName>Northstar RxLLC</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-12-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>16714-031-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (16714-031-09)</PackageDescription>
<NDC11Code>16714-0031-09</NDC11Code>
<ProductNDC>16714-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078254</ApplicationNumber>
<LabelerName>Northstar RxLLC</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-12-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>21695-031-90</NDCCode>
<PackageDescription>90 BOTTLE in 1 BOTTLE (21695-031-90) > 60 TABLET, FILM COATED in 1 BOTTLE (21695-031-60)</PackageDescription>
<NDC11Code>21695-0031-90</NDC11Code>
<ProductNDC>21695-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078216</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Citalopram HBr is an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram HBr is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile, HBr with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram HBr occurs as a fine, white to off-white powder.Citalopram HBr is sparingly soluble in water and soluble in ethanol. Citalopram hydrobromide is available as tablets. Citalopram hydrobromide 10 mg tablets are film-coated, round shaped tablets containing citalopram HBr in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram HBr in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, starch, croscarmellose sodium, copovidone, magnesium stearate, hypromellose, titanium dioxide, ferric oxide red, ferric oxide yellow, glycerin, and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>27808-031-01</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (27808-031-01)</PackageDescription>
<NDC11Code>27808-0031-01</NDC11Code>
<ProductNDC>27808-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nexiclon Xr</ProprietaryName>
<NonProprietaryName>Clonidine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101217</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022500</ApplicationNumber>
<LabelerName>Tris Pharma, Inc.</LabelerName>
<SubstanceName>CLONIDINE</SubstanceName>
<StrengthNumber>.26</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>33342-031-10</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (33342-031-10) </PackageDescription>
<NDC11Code>33342-0031-10</NDC11Code>
<ProductNDC>33342-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
<NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202164</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pramipexole dihydrochloride tablets are a non-ergot dopamine agonist indicated for the treatment of. · Parkinson’s disease (PD) (1.1) Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
<Description>Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C10H17N3S2HClH2O, and its molecular weight is 302.26. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.118 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.25 mg: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.235 mg pramipexole dihydrochloride.Pramipexole dihydrochloride tablets 0.5 mg: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.47 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1 mg tablets: Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.94 mg pramipexole dihydrochloride.Pramipexole dihydrochloride 1.5 mg tablets: Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride.Inactive ingredients for all strengths of pramipexole dihydrochloride tablets consist of mannitol, pregelatinized starch, colloidal silicon dioxide, povidone, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>37808-031-90</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (37808-031-90)</PackageDescription>
<NDC11Code>37808-0031-90</NDC11Code>
<ProductNDC>37808-031</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19910915</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>H E B</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>43353-031-60</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-031-60)</PackageDescription>
<NDC11Code>43353-0031-60</NDC11Code>
<ProductNDC>43353-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Crestor</ProprietaryName>
<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030818</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021366</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>CRESTOR is an HMG Co‑A reductase inhibitor indicated for: 1 patients with primary hyperlipidemia and mixed dyslipidemia as an adjunct to diet to reduce elevated total‑C, LDL‑C, ApoB, nonHDL‑C, and TG levels and to increase HDL‑C (1.1), 2 patients with hypertriglyceridemia as an adjunct to diet (1.2), 3 patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.3), 4 patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL‑C, total-C, and ApoB (1.4), 5 slowing the progression of atherosclerosis as part of a treatment strategy to lower total‑C and LDL‑C as an adjunct to diet (1.5), 6 pediatric patients 10 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total‑C, LDL‑C and ApoB after failing an adequate trial of diet therapy (1.1), 7 risk reduction of MI, stroke, and arterial revascularization procedures in patients without clinically evident CHD, but with multiple risk factors (1.6).</IndicationAndUsage>
<Description>CRESTOR (rosuvastatin calcium) is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium is (C22H27FN3O6S)2Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. CRESTOR Tablets for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: microcrystalline cellulose NF, lactose monohydrate NF, tribasic calcium phosphate NF, crospovidone NF, magnesium stearate NF, hypromellose NF, triacetin NF, titanium dioxide USP, yellow ferric oxide, and red ferric oxide NF.</Description>
</NDC>
<NDC>
<NDCCode>47335-031-81</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-031-81) </PackageDescription>
<NDC11Code>47335-0031-81</NDC11Code>
<ProductNDC>47335-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205905</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride extended-release capsules are orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended-release pellets with the labeled amount of memantine hydrochloride and the following inactive ingredients: sugar spheres, talc, hypromellose, polyethylene glycol, methyl cellulose, polysorbate 80, ethyl cellulose and triethyl citrate. The capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, iron oxide yellow (7 mg, 14 mg), FD&C Blue #1 (14 mg, 21 mg, 28 mg), FD&C yellow #6 (14 mg, 21 mg, 28 mg) and D&C yellow #10 (14 mg, 21 mg, 28 mg). The imprinting ink contains shellac, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>52343-031-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (52343-031-90) </PackageDescription>
<NDC11Code>52343-0031-90</NDC11Code>
<ProductNDC>52343-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080131</StartMarketingDate>
<EndMarketingDate>20200901</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078787</ApplicationNumber>
<LabelerName>ACETRIS HEALTH, LLC</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20080131</StartMarketingDatePackage>
<EndMarketingDatePackage>20200901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54304-031-02</NDCCode>
<PackageDescription>90 mL in 1 BOTTLE, PLASTIC (54304-031-02) </PackageDescription>
<NDC11Code>54304-0031-02</NDC11Code>
<ProductNDC>54304-031</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wish/ Wish Ultra Slim Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>01</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200425</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Zhejiang Meizhiyuan Cosmetics Co., Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70.4</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60429-031-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (60429-031-90)</PackageDescription>
<NDC11Code>60429-0031-90</NDC11Code>
<ProductNDC>60429-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Captopril</ProprietaryName>
<NonProprietaryName>Captopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074505</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>CAPTOPRIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>60763-031-11</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (60763-031-11) </PackageDescription>
<NDC11Code>60763-0031-11</NDC11Code>
<ProductNDC>60763-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pitavastatin</ProprietaryName>
<NonProprietaryName>Pitavastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205955</ApplicationNumber>
<LabelerName>STASON PHARMACEUTICALS, INC.</LabelerName>
<SubstanceName>PITAVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63187-031-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (63187-031-90) </PackageDescription>
<NDC11Code>63187-0031-90</NDC11Code>
<ProductNDC>63187-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090705</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Postherpetic Neuralgia. Gabapentin is indicated for the management of postherpetic neuralgia in adults. Epilepsy. Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 – 12 years.</IndicationAndUsage>
<Description>Gabapentin Capsules, USP are supplied as imprinted hard gelatin capsules containing 100 mg, 300 mg and 400 mg of gabapentin, USP. The inactive ingredients are mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide. The 300 mg capsule contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. The 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10 and titanium dioxide. Gabapentin, USP is described as 1-(aminomethyl) cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24. The structural formula of gabapentin is. C9H17NO2 M.W. 171.24. C9H17NO2 M.W. 171.24. C9H17NO2 M.W. 171.24. C9H17NO2 M.W. 171.24. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25.</Description>
</NDC>
<NDC>
<NDCCode>65162-031-09</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (65162-031-09) </PackageDescription>
<NDC11Code>65162-0031-09</NDC11Code>
<ProductNDC>65162-031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pitavastatin</ProprietaryName>
<NonProprietaryName>Pitavastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240821</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205961</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>PITAVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: : 1 Adults with primary hyperlipidemia. , 2 Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). .</IndicationAndUsage>
<Description>Pitavastatin tablets for oral use is an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (+)monocalcium bis{(3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoate} pentahydrate. The structural formula is. The molecular formula for pitavastatin is C50H46CaF2N2O8 ∙5H2O and the molecular weight is 971.06 g/mol. Pitavastatin is odorless and occurs as white to off-white powder. It is freely soluble in tetrahydrofuran, soluble in ethylene glycol, sparingly soluble in dimethyl sulphoxide and in 50 % aqueous acetonitrile, slightly soluble in methanol, very slightly soluble in water and in ethanol (96%), and insoluble in diethyl ether. Pitavastatin is hygroscopic and slightly unstable in light. Each film-coated tablet of pitavastatin contains 1 mg, 2 mg, or 4 mg of pitavastatin, which is equivalent to 1.045 mg, 2.09 mg, or 4.18 mg, respectively, of pitavastatin calcium and the following inactive ingredients: hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium aluminometasilicate, and magnesium stearate. The film-coating contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, titanium dioxide, and triethyl citrate.</Description>
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