Gemcitabine
- Product NDC
- 0143-9394
- 11-digit product format
- 001439394
- Labeler code
- 0143
- Product ID
- 0143-9394_37afef8b-07d8-4857-934a-ddea3296e592
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemcitabine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA206617
- Marketing category
- ANDA
- Marketing start
- 2021-06-25
- Marketing end
- 0000-00-00
- Substance
- GEMCITABINE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0143-9394-01 | 00143939401 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9394-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 2021-06-25 | 0000-00-00 | No | No | Current |