Imatinib Mesylate
- Product NDC
- 0054-0248
- 11-digit product format
- 000540248
- Labeler code
- 0054
- Product ID
- 0054-0248_6bee6fa5-7883-4e39-b381-e2ed52f566e1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Imatinib Mesylate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA207586
- Marketing category
- ANDA
- Marketing start
- 2018-09-28
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-0248-12 | 00054024812 | 3 BLISTER PACK in 1 CARTON (0054-0248-12) > 10 TABLET, FILM COATED in 1 BLISTER PACK | 3 blister pack | 2018-09-28 | 0000-00-00 | No | No | Current |
| 0054-0248-22 | 00054024822 | 90 TABLET, FILM COATED in 1 BOTTLE (0054-0248-22) | | 2018-09-28 | 0000-00-00 | No | No | Current |