DASATINIB
- Product NDC
- 46708-687
- 11-digit product format
- 467080687
- Labeler code
- 46708
- Product ID
- 46708-687_645fcf26-1b2f-40c5-881b-8effe02defbd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DASATINIB
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA216261
- Marketing category
- ANDA
- Marketing start
- 2025-11-11
- Substance
- DASATINIB
- Active strength
- 80 mg/1
- Pharmacologic classes
- Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DASATINIB
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DASATINIB | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RBZ1571X5H |
| Rxcui | 643105, 643107, 643109, 799047, 1045402, 1045406 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-687-30 | DASATINIB | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-687-30 | 46708068730 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-687-30) | 2025-11-11 | No | No | Current |