Prescription drug · NDA
Opipza (aripiprazole) NDC 15370-403
Aripiprazole 10 mg/1 · Film, Soluble · Oral · Carwin Pharmaceutical Associates, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 15370-403-30 | 15370040330 | 30 POUCH in 1 CARTON (15370-403-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-403-01)Marketed from Nov 1, 2024 |
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)
- Opipza
- Generic name (nonproprietary)
- aripiprazole
- Active ingredients
- Aripiprazole — 10 mg/1
- Dosage form
- Film, Soluble
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216655
- Marketing start
- Listing expires
- Identifiers
- Product ID 15370-403_3dbb4e6d-14f0-4668-877c-2f4d9a94751fSPL ID 3dbb4e6d-14f0-4668-877c-2f4d9a94751fSPL set ID b47ede68-8942-4432-af7e-57afc14b2ba4RxCUI 2697158, 2697164, 2697165, 2697167, 2697168, 2697170UNII 82VFR53I78UPC 0315370403307, 0315370402300, 0315370401303
- 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
N415370040330followed by a unit qualifier and the quantityPackage 15370-0403-30. 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)
OPIPZA is indicated for the: treatment of schizophrenia in patients ages 13 years and older adjunctive treatment of major depressive disorder (MDD) in adults treatment of irritability associated with autistic disorder in pediatric patients 6 years and older treatment of Tourette's disorder in pediatric patients 6 years and older OPIPZA is an atypical antipsychotic indicated for: treatment of schizophrenia in patients ages 13 years and older ( 1 ) adjunctive treatment of major depressive disorder (MDD) in adults ( 1 ) irritability associated with autistic disorder in pediatric patients 6 years and older ( 1 ) treatment of Tourette's disorder in pediatric patients 6 years and older ( 1 )…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 216655
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.