Dasatinib
- Product NDC
- 60505-3630
- 11-digit product format
- 605053630
- Labeler code
- 60505
- Product ID
- 60505-3630_ec5a2f19-c89e-c4cd-c819-a22c585d18b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dasatinib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA202103
- Marketing category
- ANDA
- Marketing start
- 2024-09-03
- Substance
- DASATINIB
- Active strength
- 70 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 | 70 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 |
|---|
| 60505-3630-6 | Dasatinib | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-3630 | DASATINIB TABLET, FILM COATED [APOTEX CORP.] | 14 | Current NDC, 1 package rows | 20240903_2ed87763-f018-abdb-c0ab-daa5e441b397.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 60505-3630-6 | 60505363006 | 60 TABLET, FILM COATED in 1 BOTTLE (60505-3630-6) | 2024-09-03 | No | No | Historical |