Imatinib Mesylate
- Product NDC
- 42292-044
- 11-digit product format
- 422920044
- Labeler code
- 42292
- Product ID
- 42292-044_3ed7760b-0703-b47e-e063-6294a90a61f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- imatinib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Institutional Inc
- Application
- ANDA204644
- Marketing category
- ANDA
- Marketing start
- 2017-09-07
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Imatinib Mesylate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IMATINIB MESYLATE | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8A1O1M485B |
| Rxcui | 403878, 403879 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42292-044-01 | Imatinib Mesylate | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 15 |
| 42292-044-03 | Imatinib Mesylate | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42292-044 | IMATINIB MESYLATE (IMATINIB) TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20241004_1debf3a0-7587-47d7-8ea6-e739698d7297.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 |
|---|
| 42292-044-01 | 42292004401 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 42292-044-03 | 42292004403 | 30 BLISTER PACK in 1 CARTON (42292-044-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (42292-044-01) | 30 blister pack | 2017-09-07 | 0000-00-00 | No | No | Current |