Gemcitabine
- Product NDC
- 70860-205
- 11-digit product format
- 708600205
- Labeler code
- 70860
- Product ID
- 70860-205_70fe5514-22d7-4a00-bf81-b4aa9d6de706
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gemcitabine hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Athenex Pharmaceutical Division, LLC.
- Application
- ANDA204520
- Marketing category
- ANDA
- Marketing start
- 2017-07-31
- Marketing end
- 0000-00-00
- Substance
- GEMCITABINE HYDROCHLORIDE
- Active strength
- 1 g/25mL
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70860-205-50 | 70860020550 | 1 VIAL in 1 CARTON (70860-205-50) > 25 mL in 1 VIAL | 1 vial | 2017-07-31 | 0000-00-00 | No | No | Current |