Imatinib Mesylate
- Product NDC
- 65162-794
- 11-digit product format
- 651620794
- Labeler code
- 65162
- Product ID
- 65162-794_86a4b0ad-816a-4768-aecd-0fe4a39e51ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Imatinib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA207495
- Marketing category
- ANDA
- Marketing start
- 2019-02-08
- 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-794 | IMATINIB MESYLATE (IMATINIB) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] | 25 | Legacy NDC | 20241027_1139f461-dc02-45f0-b8fd-70552315c6d6.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-794-03 | 65162079403 | 30 TABLET, FILM COATED in 1 BOTTLE (65162-794-03) | 2019-02-08 | 0000-00-00 | No | No | Current |
| 65162-794-09 | 65162079409 | 90 TABLET, FILM COATED in 1 BOTTLE (65162-794-09) | 2019-02-08 | 0000-00-00 | No | No | Current |