OPIPZA
- Product NDC
- 15370-403
- 11-digit product format
- 153700403
- Labeler code
- 15370
- Product ID
- 15370-403_3dbb4e6d-14f0-4668-877c-2f4d9a94751f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ARIPIPRAZOLE
- Dosage form
- FILM, SOLUBLE
- Route
- ORAL
- Labeler
- Carwin Pharmaceutical Associates, LLC
- Application
- NDA216655
- Marketing category
- NDA
- Marketing start
- 2024-11-01
- Substance
- ARIPIPRAZOLE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OPIPZA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ARIPIPRAZOLE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 82VFR53I78 |
| Rxcui | 2697158, 2697164, 2697165, 2697167, 2697168, 2697170 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 15370-403-01 | OPIPZA | 1 in 1 POUCH | FILM, SOLUBLE | 1 | | 2 |
| 15370-403-30 | OPIPZA | 30 in 1 CARTON | FILM, SOLUBLE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 15370-403 | OPIPZA (ARIPIPRAZOLE) FILM, SOLUBLE [CARWIN PHARMACEUTICAL ASSOCIATES, LLC] | 2 | Current NDC, 2 package rows | 20250131_b47ede68-8942-4432-af7e-57afc14b2ba4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 15370-403-01 | 15370040301 | 1 in 1 POUCH | | | | | Historical |
| 15370-403-30 | 15370040330 | 30 POUCH in 1 CARTON (15370-403-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-403-01) | 30 pouch | 2024-11-01 | No | No | Current |