Prescription drug · ANDA
Aripiprazole NDC 70518-0970
Aripiprazole 5 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-0970-3 | 70518097003 | 180 TABLET in 1 BOTTLE, PLASTIC (70518-0970-3)Marketed from Sep 21, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204838
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-0970_55a0ef8f-b10f-31f6-e063-6394a90ad377SPL ID 55a0ef8f-b10f-31f6-e063-6394a90ad377SPL set ID a1191a90-eb83-4a59-948c-b9774d2c83a5RxCUI 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
N470518097003followed by a unit qualifier and the quantityPackage 70518-0970-03. 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 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 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7367 |
| 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 |