Prescription drug · ANDA
Aripiprazole NDC 63187-965
Aripiprazole 2 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-965-30 | 63187096530 | 30 TABLET in 1 BOTTLE (63187-965-30)Marketed from Jan 1, 2018 | |
| 63187-965-60 | 63187096560 | 60 TABLET in 1 BOTTLE (63187-965-60)Marketed from Jan 1, 2018 | |
| 63187-965-90 | 63187096590 | 90 TABLET in 1 BOTTLE (63187-965-90)Marketed from Jan 1, 2018 |
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 — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204838
- Marketing start
- Listing expires
- Identifiers
- Product ID 63187-965_3f575cc4-f92e-4e55-aeb2-c634fe3411d3SPL ID 3f575cc4-f92e-4e55-aeb2-c634fe3411d3SPL set ID dbdc8fbe-c75f-4f17-a2cd-9f23802dcc5dRxCUI 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
N463187096530followed by a unit qualifier and the quantityPackage 63187-0965-30. 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 tablets are 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 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 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 |