Gemcitabine Hydrochloride
- Product NDC
- 68001-282
- 11-digit product format
- 680010282
- Labeler code
- 68001
- Product ID
- 68001-282_c6640762-8bde-4b8a-e053-2a95a90a4673
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemcitabine Hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- BluePoint Laboratories
- Application
- ANDA091594
- Marketing category
- ANDA
- Marketing start
- 2011-07-25
- Marketing end
- 2021-08-01
- Substance
- GEMCITABINE HYDROCHLORIDE
- Active strength
- 38 mg/mL
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
|---|
| 68001-282-25 | 68001028225 | 1 VIAL in 1 CARTON (68001-282-25) > 5 mL in 1 VIAL (68001-282-22) | 1 vial | 2016-05-23 | 0000-00-00 | No | No | Current |
| 68001-282-26 | 68001028226 | 1 VIAL in 1 CARTON (68001-282-26) > 25 mL in 1 VIAL (68001-282-23) | 1 vial | 2016-05-23 | 0000-00-00 | No | No | Current |
| 68001-282-27 | 68001028227 | 1 VIAL in 1 CARTON (68001-282-27) > 50 mL in 1 VIAL (68001-282-24) | 1 vial | 2016-05-23 | 0000-00-00 | No | No | Current |