imatinib mesylate
- Product NDC
- 0832-0533
- 11-digit product format
- 008320533
- Labeler code
- 0832
- Product ID
- 0832-0533_47f6137e-e0ea-4ada-e063-6394a90a37b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- imatinib mesylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- ANDA212135
- Marketing category
- ANDA
- Marketing start
- 2024-05-17
- Marketing end
- 2027-01-31
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- imatinib mesylate
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 |
|---|
| 0832-0533-03 | imatinib mesylate | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0832-0533 | IMATINIB MESYLATE TABLET [UPSHER-SMITH LABORATORIES, LLC] | 2 | Current NDC, 1 package rows | 20241207_5d07ac08-962e-41a8-8a3c-50febc8c5f34.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 |
|---|
| 0832-0533-03 | 00832053303 | 30 TABLET in 1 BOTTLE (0832-0533-03) | 30 tablet | 2024-05-17 | 2027-01-31 | No | No | Historical |