| Product NDC: | 59148-018 |
| Proprietary Name: | ABILIFY MAINTENA KIT |
| Non Proprietary Name: | aripiprazole |
| Active Ingredient(s): | 300 mg/1.5mL & nbsp; aripiprazole |
| Administration Route(s): | INTRAMUSCULAR |
| Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 59148-018 |
| Labeler Name: | Otsuka America Pharmaceutical, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA202971 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20130402 |
| Package NDC: | 59148-018-71 |
| Package Description: | 1 VIAL in 1 KIT (59148-018-71) > 1.5 mL in 1 VIAL |
| NDC Code | 59148-018-71 |
| Proprietary Name | ABILIFY MAINTENA KIT |
| Package Description | 1 VIAL in 1 KIT (59148-018-71) > 1.5 mL in 1 VIAL |
| Product NDC | 59148-018 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | aripiprazole |
| Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE |
| Route Name | INTRAMUSCULAR |
| Start Marketing Date | 20130402 |
| Marketing Category Name | NDA |
| Labeler Name | Otsuka America Pharmaceutical, Inc. |
| Substance Name | ARIPIPRAZOLE |
| Strength Number | 300 |
| Strength Unit | mg/1.5mL |
| Pharmaceutical Classes | Atypical Antipsychotic [EPC] |