Prescription drug · ANDA
Aripiprazole NDC 46708-261
Aripiprazole 15 mg/1 · Tablet, Orally disintegrating · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-261-10 | 46708026110 | 30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (46708-261-10)Marketed from May 21, 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 — 15 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202102
- Marketing start
- Listing expires
- Identifiers
- Product ID 46708-261_1ea06df8-17dc-46eb-921a-2b52d41ea622SPL ID 1ea06df8-17dc-46eb-921a-2b52d41ea622SPL set ID 4f1691a8-724e-430d-9bab-27b59ef9bd4eRxCUI 643019, 643022UNII 82VFR53I78UPC 0346708261108, 0346708260101
- 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
N446708026110followed by a unit qualifier and the quantityPackage 46708-0261-10. 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 Orally Disintegrating 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 indicated as oral formulations for the: Schizophrenia (14.1)
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 Inc. | 62332-104 |
| Aripiprazole | Aripiprazole 10 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-260 |