Prescription drug · ANDA
Aripiprazole NDC 62332-104
Aripiprazole 15 mg/1 · Tablet, Orally disintegrating · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-104-30 | 62332010430 | 30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (62332-104-30)Marketed from Jul 7, 2016 |
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 — 15 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202102
- Marketing start
- Listing expires
- Identifiers
- Product ID 62332-104_ed78fbb6-5691-44be-859d-16b30f768614SPL ID ed78fbb6-5691-44be-859d-16b30f768614SPL set ID de2dc5fd-ecb4-4445-9cfb-10e64fe3269dRxCUI 643019, 643022UNII 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
N462332010430followed by a unit qualifier and the quantityPackage 62332-0104-30. 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 Orally Disintegrating Tablets, USP are indicated for the treatment of: •Schizophrenia [see Clinical Studies (14.1)] • Irritability Associated with Autistic Disorder [see Clinical Studies (14.4)] • Treatment of Tourette’s Disorder [see Clinical Studies (14.5)] 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 202102
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 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Inc. | 62332-103 |
| Aripiprazole | Aripiprazole 15 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-261 |
| Aripiprazole | Aripiprazole 10 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-260 |