Prescription drug · ANDA
Aripiprazole NDC 50090-6063
Aripiprazole 20 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6063-0 | 50090606300 | 30 TABLET in 1 BOTTLE (50090-6063-0)Marketed from Sep 7, 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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206251
- Marketing start
- Listing expires
- Identifiers
- Product ID 50090-6063_6cd1204f-119f-4913-8065-f458f2c4598fSPL ID 6cd1204f-119f-4913-8065-f458f2c4598fSPL set ID aaf7dc7e-04f3-442b-86d7-5f54d17d102cRxCUI 349553UNII 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
N450090606300followed by a unit qualifier and the quantityPackage 50090-6063-00. 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 [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 206251
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 15 mg/1 | TabletOral | Accord Healthcare, Inc. | 16729-281 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Accord Healthcare, Inc. | 16729-278 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Accord Healthcare, Inc. | 16729-279 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Accord Healthcare, Inc. | 16729-280 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Accord Healthcare, Inc. | 16729-282 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Accord Healthcare, Inc. | 16729-283 |