Abilify Asimtufii
- Product NDC
- 59148-102
- 11-digit product format
- 591480102
- Labeler code
- 59148
- Product ID
- 59148-102_284a898a-06c2-4ef9-9cb9-5d3e6cf94f9c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Aripiprazole
- Dosage form
- INJECTION, SUSPENSION, EXTENDED RELEASE
- Route
- INTRAMUSCULAR
- Labeler
- Otsuka America Pharmaceutical, Inc
- Application
- NDA217006
- Marketing category
- NDA
- Marketing start
- 2023-04-27
- Substance
- ARIPIPRAZOLE
- Active strength
- 720 mg/2.4mL
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Abilify Asimtufii
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ARIPIPRAZOLE | 720 mg/2.4mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 82VFR53I78 |
| Rxcui | 2636637, 2636640, 2636645, 2636646 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 915afeb5-0b22-42c0-86ea-77abf1c5fe15 | Product name | 1 | 20250307 |
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 51c1e9bf-32c5-4a7b-b010-f93a90af7b6e | Product name | 1 | 20231010 |
| 34645f32-2ac4-41bf-9c61-8107e4764a26 | Product name | 1 | 20181210 |
| f8ff9e17-cd6c-4547-98c3-f5db0d1fc25d | Product name | 1 | 20180110 |
| 14eaf619-f285-4cd0-9f39-d9dd8f3d9c02 | Product name | 1 | 20170824 |
| 8223ef47-de85-24dd-a9c7-5a041d2634a2 | Product name | 9 | 20170223 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59148-102-80 | Abilify Asimtufii | 2.4 mL in 1 SYRINGE | INJECTION, SUSPENSION, EXTENDED | 2.4 | 6 | |
| 59148-102-80 | Abilify Asimtufii | 1 in 1 CARTON | INJECTION, SUSPENSION, EXTENDED | 1 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59148-102-80 | ML - Milliliter | 59148-102 | 35084241-526a-4d26-a9f8-ab8779a683c4 | 1 | 2023-06-06 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2636640 | Abilify Asimtufii 720 MG in 2.4 ML Extended Release Prefilled Syringe | PSN | da4c07fd-1130-4341-bb44-63acfa4162be | 6 |
| 2636646 | Abilify Asimtufii 960 MG in 3.2 ML Extended Release Prefilled Syringe | PSN | da4c07fd-1130-4341-bb44-63acfa4162be | 6 |
| 2636637 | ARIPiprazole 720 MG in 2.4 ML Extended Release Prefilled Syringe | PSN | da4c07fd-1130-4341-bb44-63acfa4162be | 6 |
| 2636645 | ARIPiprazole 960 MG in 3.2 ML Extended Release Prefilled Syringe | PSN | da4c07fd-1130-4341-bb44-63acfa4162be | 6 |
| 2636640 | 2.4 ML aripiprazole 300 MG/ML Prefilled Syringe [Abilify] | SBD | da4c07fd-1130-4341-bb44-63acfa4162be | 6 |
| 2636646 | 3.2 ML aripiprazole 300 MG/ML Prefilled Syringe [Abilify] | SBD | da4c07fd-1130-4341-bb44-63acfa4162be | 6 |
| 2636637 | 2.4 ML aripiprazole 300 MG/ML Prefilled Syringe | SCD | da4c07fd-1130-4341-bb44-63acfa4162be | 6 |
| 2636645 | 3.2 ML aripiprazole 300 MG/ML Prefilled Syringe | SCD | da4c07fd-1130-4341-bb44-63acfa4162be | 6 |
| 2636640 | 2.4 ML Abilify 300 MG/ML Prefilled Syringe | SY | da4c07fd-1130-4341-bb44-63acfa4162be | 6 |
| 2636646 | 3.2 ML Abilify 300 MG/ML Prefilled Syringe | SY | da4c07fd-1130-4341-bb44-63acfa4162be | 6 |
| 2636640 | Abilify Asimtufii 720 MG per 2.4 ML extended release Prefilled Syringe | SY | da4c07fd-1130-4341-bb44-63acfa4162be | 6 |
| 2636646 | Abilify Asimtufii 960 MG per 3.2 ML extended release Prefilled Syringe | SY | da4c07fd-1130-4341-bb44-63acfa4162be | 6 |
| 2636637 | aripiprazole 720 MG per 2.4 ML extended release Prefilled Syringe | SY | da4c07fd-1130-4341-bb44-63acfa4162be | 6 |
| 2636645 | aripiprazole 960 MG per 3.2 ML extended release Prefilled Syringe | SY | da4c07fd-1130-4341-bb44-63acfa4162be | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 59148-102-80 | 59148010280 | 1 SYRINGE in 1 CARTON (59148-102-80) / 2.4 mL in 1 SYRINGE | 1 syringe | 2023-04-27 | No | No | Current |