imatinib mesylate
- Product NDC
- 72819-186
- 11-digit product format
- 728190186
- Labeler code
- 72819
- Product ID
- 72819-186_05dbf49e-73b7-3190-e063-6394a90a1a64
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- imatinib mesylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Archis Pharma LLC
- Application
- ANDA212135
- Marketing category
- ANDA
- Marketing start
- 2022-09-01
- 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 |
|---|
| 72819-186-03 | imatinib mesylate | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72819-186 | IMATINIB MESYLATE TABLET [ARCHIS PHARMA LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20230922_9de8d8b9-cf88-4960-82b7-89e5ceb7720e.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 |
|---|
| 72819-186-03 | 72819018603 | 30 TABLET in 1 BOTTLE (72819-186-03) | 30 tablet | 2022-09-01 | 0000-00-00 | No | No | Current |