IMATINIB MESYLATE
- Product NDC
- 31722-296
- 11-digit product format
- 317220296
- Labeler code
- 31722
- Product ID
- 31722-296_4467e670-2d3a-9832-e063-6394a90a569b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IMATINIB MESYLATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA212975
- Marketing category
- ANDA
- Marketing start
- 2025-04-14
- Substance
- IMATINIB MESYLATE
- Active strength
- 100 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 | 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 |
|---|
| 31722-296-90 | IMATINIB MESYLATE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-296 | IMATINIB MESYLATE (IMATINIB MESYLATE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20250427_e97f0238-b9da-46af-83a3-0826e39893e8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 31722-296-90 | 31722029690 | 90 TABLET, FILM COATED in 1 BOTTLE (31722-296-90) | 2025-04-14 | No | No | Current |