imatinib mesylate
- Product NDC
- 47335-472
- 11-digit product format
- 473350472
- Labeler code
- 47335
- Product ID
- 47335-472_ad13dbca-474d-4492-9c25-e0e175143d8c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- imatinib mesylate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA078340
- Marketing category
- ANDA
- Marketing start
- 2016-02-01
- Substance
- IMATINIB MESYLATE
- Active strength
- 100 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 | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8A1O1M485B |
| Rxcui | 403878, 403879 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 47335-472-13 | 2020-08-05 | C162847 | 48780-1 | ab0e2407-33d6-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use IMATINIB MESYLATE TABLETS safely and effectively. See full prescribing information for IMATINIB MESYLATE TABLETS. IMATINIB MESYLATE tablets, for oral use Initial U.S. Approval: 2001 |
| 47335-472-81 | 2020-08-05 | C162847 | 48780-1 | ab0e2407-33d6-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use IMATINIB MESYLATE TABLETS safely and effectively. See full prescribing information for IMATINIB MESYLATE TABLETS. IMATINIB MESYLATE tablets, for oral use Initial U.S. Approval: 2001 |
| 47335-472-83 | 2020-08-05 | C162847 | 48780-1 | ab0e2407-33d6-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use IMATINIB MESYLATE TABLETS safely and effectively. See full prescribing information for IMATINIB MESYLATE TABLETS. IMATINIB MESYLATE tablets, for oral use Initial U.S. Approval: 2001 |
| 47335-472-88 | 2020-08-05 | C162847 | 48780-1 | ab0e2407-33d6-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use IMATINIB MESYLATE TABLETS safely and effectively. See full prescribing information for IMATINIB MESYLATE TABLETS. IMATINIB MESYLATE tablets, for oral use Initial U.S. Approval: 2001 |
| 47335-472-13 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-33d6-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use IMATINIB MESYLATE TABLETS safely and effectively. See full prescribing information for IMATINIB MESYLATE TABLETS. IMATINIB MESYLATE tablets, for oral use Initial U.S. Approval: 2001 |
| 47335-472-81 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-33d6-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use IMATINIB MESYLATE TABLETS safely and effectively. See full prescribing information for IMATINIB MESYLATE TABLETS. IMATINIB MESYLATE tablets, for oral use Initial U.S. Approval: 2001 |
| 47335-472-83 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-33d6-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use IMATINIB MESYLATE TABLETS safely and effectively. See full prescribing information for IMATINIB MESYLATE TABLETS. IMATINIB MESYLATE tablets, for oral use Initial U.S. Approval: 2001 |
| 47335-472-88 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-33d6-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use IMATINIB MESYLATE TABLETS safely and effectively. See full prescribing information for IMATINIB MESYLATE TABLETS. IMATINIB MESYLATE tablets, for oral use Initial U.S. Approval: 2001 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-472-13 | imatinib mesylate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 26 |
| 47335-472-81 | imatinib mesylate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 26 |
| 47335-472-83 | imatinib mesylate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 26 |
| 47335-472-88 | imatinib mesylate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 26 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-472 | IMATINIB MESYLATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 26 | Current NDC, Legacy NDC, 4 package rows | 20220916_07764bf9-21b4-4e32-9d7e-e348f8e4291f.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 |
|---|
| 47335-472-13 | 47335047213 | 500 TABLET, FILM COATED in 1 BOTTLE (47335-472-13) | 2016-02-01 | 0000-00-00 | No | No | Current |
| 47335-472-81 | 47335047281 | 90 TABLET, FILM COATED in 1 BOTTLE (47335-472-81) | 2016-02-01 | 0000-00-00 | No | No | Current |
| 47335-472-83 | 47335047283 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-472-83) | 2016-02-01 | 0000-00-00 | No | No | Current |
| 47335-472-88 | 47335047288 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-472-88) | 2016-02-01 | 0000-00-00 | No | No | Current |