DASATINIB
- Product NDC
- 59651-545
- 11-digit product format
- 596510545
- Labeler code
- 59651
- Product ID
- 59651-545_58ce42c6-10bd-4bb4-bf89-eae8ed82c339
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DASATINIB
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA216547
- Marketing category
- ANDA
- Marketing start
- 2025-04-22
- 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 |
|---|
| 59651-545-15 | DASATINIB | 15 in 1 BLISTER PACK | TABLET | 15 | | 1 |
| 59651-545-15 | DASATINIB | 1 in 1 CARTON | TABLET | 1 | | 1 |
| 59651-545-30 | DASATINIB | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-545 | DASATINIB TABLET [AUROBINDO PHARMA LIMITED] | 1 | Current NDC, 3 package rows | 20250424_58ce42c6-10bd-4bb4-bf89-eae8ed82c339.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 |
|---|
| 59651-545-15 | 59651054515 | 1 BLISTER PACK in 1 CARTON (59651-545-15) / 15 TABLET in 1 BLISTER PACK | 1 blister pack | 2025-04-22 | No | No | Current |
| 59651-545-30 | 59651054530 | 30 TABLET in 1 BOTTLE (59651-545-30) | 30 tablet | 2025-04-22 | No | No | Current |