Imatinib mesylate
- Product NDC
- 67877-633
- 11-digit product format
- 678770633
- Labeler code
- 67877
- Product ID
- 67877-633_7579620e-3748-46fa-8295-f9b47d0aa5b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- imatinib mesylate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA208302
- Marketing category
- ANDA
- Marketing start
- 2019-02-01
- Substance
- IMATINIB MESYLATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- 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
- Imatinib mesylate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IMATINIB MESYLATE | 100 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 |
|---|
| 67877-633-90 | Imatinib mesylate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-633 | IMATINIB MESYLATE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20190226_7579620e-3748-46fa-8295-f9b47d0aa5b8.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 |
|---|
| 67877-633-90 | 67877063390 | 90 TABLET, FILM COATED in 1 BOTTLE (67877-633-90) | 2019-02-01 | 0000-00-00 | No | No | Current |