Prescription drug · ANDA
Aripiprazole NDC 0904-7367
Aripiprazole 5 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7367-06 | 00904736706 | 50 BLISTER PACK in 1 CARTON (0904-7367-06) / 1 TABLET in 1 BLISTER PACKMarketed from Oct 1, 2023 | |
| 0904-7367-61 | 00904736761 | 100 BLISTER PACK in 1 CARTON (0904-7367-61) / 1 TABLET in 1 BLISTER PACKMarketed from Oct 1, 2023 |
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 204838
- Marketing start
- Listing expires
- Identifiers
- Product ID 0904-7367_9bc49e88-89a9-4b39-b03c-cc9aa3a468c4SPL ID 9bc49e88-89a9-4b39-b03c-cc9aa3a468c4SPL set ID 573c6bb6-941f-4413-8c23-826025385864RxCUI 349490, 349545, 349547, 349553, 402131, 602964UNII 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
N400904736706followed by a unit qualifier and the quantityPackage 00904-7367-06. 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 indicated for the treatment of: • Schizophrenia • Irritability Associated with Autistic Disorder • Treatment of Tourette’s Disorder Aripiprazole tablets are an atypical antipsychotic. Aripiprazole tablets are indicated for: • Schizophrenia. ( 14.1 ) • 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 ANDA 204838
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 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0970 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-898 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-896 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-897 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-902 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-899 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-901 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7366 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7368 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7369 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7774 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7370 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7371 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Proficient Rx LP | 63187-965 |