Prescription drug · ANDA
Aripiprazole NDC 46708-256
Aripiprazole 10 mg/1 · Tablet · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-256-10 | 46708025610 | 100 TABLET in 1 CARTON (46708-256-10)Marketed from Apr 28, 2015 | |
| 46708-256-30 | 46708025630 | 30 TABLET in 1 BOTTLE (46708-256-30)Marketed from Apr 28, 2015 | |
| 46708-256-31 | 46708025631 | 100 TABLET in 1 BOTTLE (46708-256-31)Marketed from Apr 28, 2015 | |
| 46708-256-71 | 46708025671 | 500 TABLET in 1 BOTTLE (46708-256-71)Marketed from Apr 28, 2015 | |
| 46708-256-91 | 46708025691 | 1000 TABLET in 1 BOTTLE (46708-256-91)Marketed from Apr 28, 2015 |
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)
- Aripiprazole
- Generic name (nonproprietary)
- aripiprazole
- Active ingredients
- Aripiprazole — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202101
- Marketing start
- Listing expires
- Identifiers
- Product ID 46708-256_5108607e-5633-4b19-82f9-6c48720960c4SPL ID 5108607e-5633-4b19-82f9-6c48720960c4SPL set ID 793fc904-2f11-4f97-a0ac-4d6910cac0f9RxCUI 349490, 349545, 349547, 349553, 402131, 602964UNII 82VFR53I78UPC 0346708258306, 0346708256302, 0346708254308, 0346708259303, 0346708255305
- 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
N446708025610followed by a unit qualifier and the quantityPackage 46708-0256-10. 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 is indicated for the treatment of: •Schizophrenia [see CLINICAL STUDIES (14.1)] Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.’s ABILIFY® (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Aripiprazole is an atypical antipsychotic indicated as oral formulations for the: •Schizophrenia (14.1)
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 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 | REMEDYREPACK INC. | 70518-2281 |
| 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 |
- openFDA data updated
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