Imatinib Mesylate
- Product NDC
- 0093-7630
- 11-digit product format
- 000937630
- Labeler code
- 0093
- Product ID
- 0093-7630_0cdf555d-a2ab-481a-9414-9aea7884298e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Imatinib Mesylate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA204285
- Marketing category
- ANDA
- Marketing start
- 2016-08-04
- 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
- Imatinib Mesylate
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-7630-56 | Imatinib Mesylate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-7630 | IMATINIB MESYLATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 13 | Current NDC, Legacy NDC, 1 package rows | 20240817_a9cfc301-3c7f-4910-8813-41dcb0b4ca69.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0093-7630-56 | 00093763056 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-7630-56) | 2016-08-04 | 0000-00-00 | No | No | Current |