Imatinib mesylate
- Product NDC
- 72485-203
- 11-digit product format
- 724850203
- Labeler code
- 72485
- Product ID
- 72485-203_2e636646-af84-4711-84b4-9092bb51ca8a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- imatinib mesylate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Armas Pharmaceuticals Inc.
- Application
- ANDA208302
- Marketing category
- ANDA
- Marketing start
- 2019-03-15
- Substance
- IMATINIB MESYLATE
- Active strength
- 400 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
- Brand name suffix
- 400 mg
- 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 | 403879 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72485-203-30 | Imatinib mesylate400 mg | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72485-203 | IMATINIB MESYLATE 400 MG (IMATINIB MESYLATE) TABLET, FILM COATED [ARMAS PHARMACEUTICALS INC.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20190315_7b7cc194-29e4-4484-a364-a1ac7d7d6cf5.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 |
|---|
| 72485-203-30 | 72485020330 | 30 TABLET, FILM COATED in 1 BOTTLE (72485-203-30) | 2019-03-15 | 0000-00-00 | No | No | Current |