GEMCITABINE HYDROCHLORIDE
- Product NDC
- 16729-092
- 11-digit product format
- 167290092
- Labeler code
- 16729
- Product ID
- 16729-092_ecb5724e-7163-e91b-e053-2995a90abe5a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GEMCITABINE HYDROCHLORIDE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA091594
- Marketing category
- ANDA
- Marketing start
- 2011-07-28
- Marketing end
- 0000-00-00
- Substance
- GEMCITABINE HYDROCHLORIDE
- Active strength
- 200 mg/5mL
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic 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 |
|---|
| 16729-092-03 | 16729009203 | 1 VIAL in 1 CARTON (16729-092-03) > 5 mL in 1 VIAL | 1 vial | 2011-07-28 | 0000-00-00 | No | No | Current |