Prescription drug · ANDA
Aripiprazole NDC 70518-2281
Aripiprazole 10 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-2281-2 | 70518228102 | 30 TABLET in 1 BLISTER PACK (70518-2281-2)Marketed from Jul 8, 2025 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202101
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-2281_5734505f-3dfb-f0d5-e063-6394a90a3b3bSPL ID 5734505f-3dfb-f0d5-e063-6394a90a3b3bSPL set ID 119e3387-39a2-4fe5-904b-c2d008425c0aRxCUI 349545UNII 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
N470518228102followed by a unit qualifier and the quantityPackage 70518-2281-02. 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 is an atypical antipsychotic. The oral formulations 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 202101
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. | 70518-2150 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-102 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-099 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-100 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-101 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8502 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-254 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-257 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-255 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-256 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-258 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-259 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Coupler LLC | 67046-0873 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Coupler LLC | 67046-1017 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Coupler LLC | 67046-1085 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-098 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-097 |