Gleevec
- Product NDC
- 0078-1490
- 11-digit product format
- 000781490
- Labeler code
- 0078
- Product ID
- 0078-1490_cbc7561e-5e16-4e05-9c07-52626c43eafc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- imatinib mesylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA021588
- Marketing category
- NDA
- Marketing start
- 2014-12-23
- Substance
- IMATINIB MESYLATE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gleevec
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IMATINIB MESYLATE | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8A1O1M485B |
| Rxcui | 403878, 403879, 404588, 404589 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0078-1490-13 | Gleevec | 3 in 1 CARTON | TABLET | 3 | | 40 |
| 0078-1490-26 | Gleevec | 10 in 1 BLISTER PACK | TABLET | 10 | | 40 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0078-1490-13 | 00078149013 | 3 BLISTER PACK in 1 CARTON (0078-1490-13) / 10 TABLET in 1 BLISTER PACK (0078-1490-26) | 3 blister pack | 2025-12-20 | No | No | Current |
| 0078-1490-26 | 00078149026 | 10 in 1 BLISTER PACK | | | | | Historical |