Prescription drug · ANDA
Aripiprazole NDC 16729-281
Aripiprazole 15 mg/1 · Tablet · Oral · Accord Healthcare, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-281-01 | 16729028101 | 100 TABLET in 1 BOTTLE, PLASTIC (16729-281-01)Marketed from Feb 15, 2017 | |
| 16729-281-10 | 16729028110 | 30 TABLET in 1 BOTTLE, PLASTIC (16729-281-10)Marketed from Feb 15, 2017 |
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
- Route
- Oral
- Labeler
- Accord Healthcare, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206251
- Marketing start
- Listing expires
- Identifiers
- Product ID 16729-281_40825d37-d601-2272-e063-6294a90af90dSPL ID 40825d37-d601-2272-e063-6294a90af90dSPL set ID 85cc7d25-414b-4b6f-a03a-48af908a16a1RxCUI 349490, 349545, 349547, 349553, 402131, 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
N416729028101followed by a unit qualifier and the quantityPackage 16729-0281-01. 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 tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder Aripiprazole is an atypical antipsychotic. Aripiprazole is indicated for: Schizophrenia ( 14.1 ) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder ( 14.2 ) Adjunctive Treatment of Major Depressive Disorder ( 14.3 ) 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 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 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 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-6063 |