Imatinib Mesylate
- Product NDC
- 68001-623
- 11-digit product format
- 680010623
- Labeler code
- 68001
- Product ID
- 68001-623_52565abd-73d5-86fb-e063-6394a90a91a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Imatinib Mesylate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA212773
- Marketing category
- ANDA
- Marketing start
- 2024-12-06
- 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 |
|---|
| 68001-623-04 | Imatinib Mesylate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-623 | IMATINIB MESYLATE TABLET, FILM COATED [BLUEPOINT LABORATORIES] | 3 | Current NDC, 1 package rows | 20250410_c0611fc0-b217-4988-acd4-b8c629ce489b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68001-623-04 | 68001062304 | 30 TABLET, FILM COATED in 1 BOTTLE (68001-623-04) | 2025-02-21 | No | No | Historical |