Prescription drug · ANDA
Aripiprazole (aripiprazole oral) NDC 31722-684
Aripiprazole 1 mg/mL · Solution · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-684-15 | 31722068415 | 1 BOTTLE in 1 CARTON (31722-684-15) / 150 mL in 1 BOTTLEMarketed from Nov 1, 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 oral
- Active ingredients
- Aripiprazole — 1 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216150
- Marketing start
- Listing expires
- Identifiers
- Product ID 31722-684_2e7a39b9-0db3-970e-e063-6394a90ae6ffSPL ID 2e7a39b9-0db3-970e-e063-6394a90ae6ffSPL set ID da47ad78-e62c-4bf3-9b53-d8cc246bcfb6RxCUI 485496UNII 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
N431722068415followed by a unit qualifier and the quantityPackage 31722-0684-15. 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 oral solution is indicated for the treatment of: • Schizophrenia [see Clinical Studies (14.1) ] • Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see Clinical Studies (14.2) ] • Irritability Associated with Autistic Disorder [see Clinical Studies (14.4) ] • Treatment of Tourette’s Disorder [see Clinical Studies (14.5) ] Aripiprazole oral solution is an atypical antipsychotic. The oral formulations are indicated for: • Schizophrenia (14.1) • Acute Treatment of Manic and Mixed Episodes associated with Bipolar I (14.2) • 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 216150
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 |
|---|---|---|---|---|
| Aripiprazolearipiprazole oral | Aripiprazole 1 mg/mL | SolutionOral | NorthStar RxLLC | 72603-445 |
| Aripiprazolearipiprazole oral | Aripiprazole 1 mg/mL | SolutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0684 |