Prescription drug · NDA
Abilify (aripiprazole) NDC 59148-007
Aripiprazole 5 mg/1 · Tablet · Oral · Otsuka America Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59148-007-13 | 59148000713 | 30 TABLET in 1 BOTTLE, PLASTIC (59148-007-13)Marketed from Nov 15, 2002 | |
| 59148-007-35 | 59148000735 | 100 TABLET in 1 BLISTER PACK (59148-007-35)Marketed from Nov 15, 2002 | |
| 59148-007-94 | 59148000794 | 7 TABLET in 1 BLISTER PACK (59148-007-94)Marketed from Nov 15, 2002 |
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
- Generic name (nonproprietary)
- aripiprazole
- Active ingredients
- Aripiprazole — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021436
- Marketing start
- Listing expires
- Identifiers
- Product ID 59148-007_1b189d15-798d-4bed-a93d-a543ed7abd81SPL ID 1b189d15-798d-4bed-a93d-a543ed7abd81SPL set ID c040bd1d-45b7-49f2-93ea-aed7220b30acRxCUI 349490, 349545, 349547, 349553, 352307, 352308, 352309, 352310, 402131, 404602, 602964, 615172UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N459148000713followed by a unit qualifier and the quantityPackage 59148-0007-13. 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 (aripiprazole) Tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder ABILIFY is an atypical antipsychotic. ABILIFY is indicated for: Schizophrenia ( 14.1 ) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder ( 14.2 ) Adjunctive Treatment of Major Depressive Disorder ( 14.3 ) Irritability Associated with Autistic Disorder ( 14.4 ) Treatment of Tourette's Disorder ( 14.5 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021436
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 |
|---|---|---|---|---|
| Abilifyaripiprazole | Aripiprazole 2 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-006 |
| Abilifyaripiprazole | Aripiprazole 20 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-010 |
| Abilifyaripiprazole | Aripiprazole 10 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-008 |
| Abilifyaripiprazole | Aripiprazole 15 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-009 |
| Abilifyaripiprazole | Aripiprazole 30 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-011 |