Prescription drug · ANDA
aripiprazole NDC 0904-6656
Aripiprazole 5 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6656-40 | 00904665640 | 500 TABLET in 1 BOTTLE (0904-6656-40)Marketed from Apr 28, 2015 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- aripiprazole
- Generic name (nonproprietary)
- aripiprazole
- Active ingredients
- Aripiprazole — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201519
- Marketing start
- Listing expires
- Identifiers
- Product ID 0904-6656_b91e66d9-c64e-4503-835f-08d3916f9e1dSPL ID b91e66d9-c64e-4503-835f-08d3916f9e1dSPL set ID 969c17aa-6abc-413c-8561-f1ad8fdde3e5RxCUI 402131UNII 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
N400904665640followed by a unit qualifier and the quantityPackage 00904-6656-40. 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)
Aripiprazole tablets are an atypical antipsychotic. Aripiprazole tablets are 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 ) 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
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201519
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 |
|---|---|---|---|---|
| aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-216 |
| aripiprazole | Aripiprazole 20 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-691 |
| aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-219 |
| aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-217 |
| aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-218 |
| aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7063 |
| aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-220 |
| aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-221 |
| aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0412 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Direct_Rx | 72189-455 |
| aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Proficient Rx LP | 82804-235 |
| aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Proficient Rx LP | 82804-236 |
| aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7003 |
| aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7108 |
| aripiprazole | Aripiprazole 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2584 |
| aripiprazole | Aripiprazole 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6563 |
| aripiprazole | Aripiprazole 15 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2643 |