Prescription drug · ANDA
Aripiprazole NDC 82009-091
Aripiprazole 15 mg/1 · Tablet · Oral · Quallent Pharmaceuticals Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82009-091-05 | 82009009105 | 500 TABLET in 1 BOTTLE (82009-091-05)Marketed from Jul 19, 2023 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206174
- Marketing start
- Listing expires
- Identifiers
- Product ID 82009-091_5c525d81-2a40-4c63-a28c-94865bf0c493SPL ID 5c525d81-2a40-4c63-a28c-94865bf0c493SPL set ID 0e0d42ad-f4c6-4e30-adc2-ab1d122428ecRxCUI 349490, 349545, 402131, 602964UNII 82VFR53I78UPC 0382009088051, 0382009090054, 0382009091051, 0382009089058
- 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
N482009009105followed by a unit qualifier and the quantityPackage 82009-0091-05. 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 Irritability Associated with Autistic Disorder Treatment of Tourette’s Disorder Aripiprazole is an atypical antipsychotic. Aripiprazole is 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 206174
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 | TabletOral | A-S Medication Solutions | 50090-6409 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-006 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-090 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-088 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-089 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1515 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1513 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7749 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1682 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Coupler LLC | 67046-1638 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2736 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-054 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-051 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-052 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-053 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-055 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-056 |