Brexpiprazole
- Product NDC
- 27241-209
- 11-digit product format
- 272410209
- Labeler code
- 27241
- Product ID
- 27241-209_430dc8c4-7349-42d5-9036-b0bdcc02a839
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brexpiprazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ajanta Pharma USA Inc.
- Application
- ANDA213718
- Marketing category
- ANDA
- Marketing start
- 2023-02-03
- Substance
- BREXPIPRAZOLE
- Active strength
- 4 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
- Brexpiprazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BREXPIPRAZOLE | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2J3YBM1K8C |
| Rxcui | 1658319, 1658327, 1658331, 1658335, 1658339, 1658343 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 27241-209-30 | Brexpiprazole | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27241-209 | BREXPIPRAZOLE TABLET [AJANTA PHARMA USA INC.] | 4 | Current NDC, 1 package rows | 20230222_993b584c-7fe6-4551-899f-39146c8508ac.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 |
|---|
| 27241-209-30 | 27241020930 | 30 TABLET in 1 BOTTLE (27241-209-30) | 30 tablet | 2023-02-03 | No | No | Current |