imatinib mesylate
- Product NDC
- 67184-0533
- 11-digit product format
- 671840533
- Labeler code
- 67184
- Product ID
- 67184-0533_a41dbedd-ee4e-401c-b446-a435929ff903
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- imatinib mesylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Qilu Pharmaceutical Co., Ltd.
- Application
- ANDA212135
- Marketing category
- ANDA
- Marketing start
- 2022-06-21
- 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
- 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 | 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 |
|---|
| 67184-0533-1 | imatinib mesylate | 30 in 1 BOTTLE | TABLET | 30 | | 35 |
| 67184-0533-2 | imatinib mesylate | 300 in 1 BOTTLE | TABLET | 300 | | 35 |
| 67184-0533-3 | imatinib mesylate | 10 in 1 BLISTER PACK | TABLET | 10 | | 35 |
| 67184-0533-3 | imatinib mesylate | 30 in 1 CARTON | TABLET | 30 | | 35 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67184-0533 | IMATINIB MESYLATE TABLET [QILU PHARMACEUTICAL CO., LTD.] | 35 | Current NDC, Legacy NDC, 4 package rows | 20241207_82eb01e0-8685-4f06-8a72-7663e8ded38f.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 |
|---|
| 67184-0533-1 | 67184053301 | 30 TABLET in 1 BOTTLE (67184-0533-1) | 30 tablet | 2022-06-21 | 0000-00-00 | No | No | Current |
| 67184-0533-2 | 67184053302 | 300 TABLET in 1 BOTTLE (67184-0533-2) | 300 tablet | 2022-06-21 | 0000-00-00 | No | No | Current |
| 67184-0533-3 | 67184053303 | 30 BLISTER PACK in 1 CARTON (67184-0533-3) / 10 TABLET in 1 BLISTER PACK | 30 blister pack | 2022-06-21 | 0000-00-00 | No | No | Current |