Prescription drug · NDA
Abilify Asimtufii (Aripiprazole) NDC 59148-114
Aripiprazole 960 mg/3.2mL · Injection, Suspension, Extended release · Intramuscular · Otsuka America Pharmaceutical, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59148-114-80 | 5914801148059148011480 | 1 SYRINGE in 1 CARTON (59148-114-80) / 3.2 mL in 1 SYRINGEMarketed from Apr 27, 2023 | |
| 59148-114-92 | 5914801149259148011492 | 1 SYRINGE in 1 CARTON (59148-114-92) / 3.2 mL in 1 SYRINGEMarketed from Apr 27, 2023 · Sample package |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Abilify Asimtufii
- Generic name (nonproprietary)
- aripiprazole
- Active ingredients
- Aripiprazole — 960 mg/3.2mL
- Dosage form
- Injection, Suspension, Extended release
- Route
- Intramuscular
- Labeler
- Otsuka America Pharmaceutical, IncNDC labeler code 59148
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217006
- Marketing start
- Listing expires
- Identifiers
- Product ID 59148-114_284a898a-06c2-4ef9-9cb9-5d3e6cf94f9cSPL ID 284a898a-06c2-4ef9-9cb9-5d3e6cf94f9cSPL set ID da4c07fd-1130-4341-bb44-63acfa4162beRxCUI 2636637, 2636640, 2636645, 2636646UNII 82VFR53I78
- Pharmacologic class
- Atypical Antipsychotic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N459148011480followed by a unit qualifier and the quantityPackage 59148-0114-80. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
ABILIFY ASIMTUFII is indicated: for the treatment of schizophrenia in adults for maintenance monotherapy treatment of bipolar I disorder in adults ABILIFY ASIMTUFII is an atypical antipsychotic indicated: for the treatment of schizophrenia in adults ( 1 ) as maintenance monotherapy treatment of bipolar I disorder in adults ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 59148-114
- What is NDC 59148-114?
- 59148-114 is the product NDC for Abilify Asimtufii (aripiprazole), Aripiprazole 960 mg/3.2mL injection, suspension, extended release, listed with the FDA by Otsuka America Pharmaceutical, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Abilify Asimtufii (Aripiprazole).
- What is the active ingredient?
- Aripiprazole.
- Who is the labeler?
- Otsuka America Pharmaceutical, Inc, NDC labeler code 59148. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Abilify Asimtufii?
- 1 other product NDC are listed under this name. See all Abilify Asimtufii NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Abilify Asimtufii products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Abilify Asimtufiiaripiprazole | Aripiprazole 720 mg/2.4mL | Injection, Suspension, Extended releaseIntramuscular | Otsuka America Pharmaceutical, Inc | 59148-102 | 59148-0102-80 |
Other NDCs under NDA 217006
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Abilify Asimtufiiaripiprazole | Aripiprazole 720 mg/2.4mL | Injection, Suspension, Extended releaseIntramuscular | Otsuka America Pharmaceutical, Inc | 59148-102 |