Imatinib Mesylate
- Product NDC
- 0904-6621
- 11-digit product format
- 009046621
- Labeler code
- 0904
- Product ID
- 0904-6621_e355608d-f891-4fff-9e9b-cfe12475f81b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Imatinib Mesylate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA079179
- Marketing category
- ANDA
- Marketing start
- 2016-08-05
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Imatinib Mesylate
- Listing expiration
- 2027-12-31
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 |
|---|
| 0904-6621-04 | Imatinib Mesylate | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 7 |
| 0904-6621-04 | Imatinib Mesylate | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6621 | IMATINIB MESYLATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250330_7c037022-7fc8-4b6e-9db3-427206c572b4.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 |
|---|
| 0904-6621-04 | 00904662104 | 30 BLISTER PACK in 1 CARTON (0904-6621-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 30 blister pack | 2016-08-05 | 0000-00-00 | No | No | Current |