Prescription drug · ANDA
Aripiprazole NDC 71335-1513
Aripiprazole 5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1513-1 | 71335151301 | 30 TABLET in 1 BOTTLE (71335-1513-1)Marketed from Feb 20, 2020 | |
| 71335-1513-2 | 71335151302 | 28 TABLET in 1 BOTTLE (71335-1513-2)Marketed from Feb 14, 2022 | |
| 71335-1513-3 | 71335151303 | 90 TABLET in 1 BOTTLE (71335-1513-3)Marketed from Feb 14, 2022 | |
| 71335-1513-4 | 71335151304 | 60 TABLET in 1 BOTTLE (71335-1513-4)Marketed from Feb 14, 2022 | |
| 71335-1513-5 | 71335151305 | 120 TABLET in 1 BOTTLE (71335-1513-5)Marketed from Feb 14, 2022 | |
| 71335-1513-6 | 71335151306 | 15 TABLET in 1 BOTTLE (71335-1513-6)Marketed from Feb 14, 2022 |
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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206174
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-1513_cfe7a124-6d12-426a-873f-eb583a8decc1SPL ID cfe7a124-6d12-426a-873f-eb583a8decc1SPL set ID fd2fa4da-2ee9-4965-b1f8-ce1c8b73ba93RxCUI 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
N471335151301followed by a unit qualifier and the quantityPackage 71335-1513-01. 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 Oral Tablets are 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. The oral formulations are indicated for: Schizophrenia ( 14.1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206174
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 | A-S Medication Solutions | 50090-6409 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-091 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-006 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-090 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-088 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-089 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1515 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7749 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1682 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Coupler LLC | 67046-1638 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2736 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-054 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-051 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-052 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-053 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-055 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-056 |