Imatinib Mesylate
- Product NDC
- 60505-2901
- 11-digit product format
- 605052901
- Labeler code
- 60505
- Product ID
- 60505-2901_0bbdf523-ac79-a5cf-7e2b-73426c1f268e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Imatinib Mesylate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotex Corp
- 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 |
|---|
| 60505-2901-0 | Imatinib Mesylate | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 19 |
| 60505-2901-0 | Imatinib Mesylate | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 19 |
| 60505-2901-1 | Imatinib Mesylate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 19 |
| 60505-2901-3 | Imatinib Mesylate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 19 |
| 60505-2901-5 | Imatinib Mesylate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 19 |
| 60505-2901-9 | Imatinib Mesylate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-2901 | IMATINIB MESYLATE TABLET, FILM COATED [APOTEX CORP] | 17 | Current NDC, Legacy NDC, 6 package rows | 20240927_0291eca5-7a1d-4a79-30be-252224d96509.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 |
|---|
| 60505-2901-0 | 60505290100 | 10 BLISTER PACK in 1 CARTON (60505-2901-0) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2016-08-05 | 0000-00-00 | No | No | Current |
| 60505-2901-1 | 60505290101 | 100 TABLET, FILM COATED in 1 BOTTLE (60505-2901-1) | | 2016-08-05 | 0000-00-00 | No | No | Current |
| 60505-2901-3 | 60505290103 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-2901-3) | | 2016-08-05 | 0000-00-00 | No | No | Current |
| 60505-2901-5 | 60505290105 | 500 TABLET, FILM COATED in 1 BOTTLE (60505-2901-5) | | 2016-08-05 | 0000-00-00 | No | No | Current |
| 60505-2901-9 | 60505290109 | 90 TABLET, FILM COATED in 1 BOTTLE (60505-2901-9) | | 2016-08-05 | 0000-00-00 | No | No | Current |