Gleevec
- Product NDC
- 0078-0649
- 11-digit product format
- 000780649
- Labeler code
- 0078
- Product ID
- 0078-0649_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 |
|---|
| 0078-0649-13 | Gleevec | 3 in 1 CARTON | TABLET | 3 | | 40 |
| 0078-0649-26 | Gleevec | 10 in 1 BLISTER PACK | TABLET | 10 | | 40 |
| 0078-0649-30 | Gleevec | 30 in 1 BOX, UNIT-DOSE | TABLET | 30 | | 40 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0078-0649 | GLEEVEC (IMATINIB MESYLATE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] | 35 | Current NDC, Legacy NDC, 3 package rows | 20240724_211ef2da-2868-4a77-8055-1cb2cd78e24b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0078-0649-13 | 00078064913 | 3 BLISTER PACK in 1 CARTON (0078-0649-13) / 10 TABLET in 1 BLISTER PACK (0078-0649-26) | 3 blister pack | 2024-03-01 | | No | No | Historical |
| 0078-0649-26 | 00078064926 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 0078-0649-30 | 00078064930 | 30 TABLET in 1 BOX, UNIT-DOSE (0078-0649-30) | 30 tablet | 2014-12-23 | 2026-12-31 | No | No | Current |