gemcitabine hydrochloride
- Product NDC
- 45963-619
- 11-digit product format
- 459630619
- Labeler code
- 45963
- Product ID
- 45963-619_f7af83fb-a439-4d8b-ba1a-fddbd803642c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gemcitabine hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA079160
- Marketing category
- ANDA
- Marketing start
- 2015-02-02
- Marketing end
- 2021-07-31
- 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
- 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 |
|---|
| 45963-619-59 | 45963061959 | 1 VIAL in 1 CARTON (45963-619-59) > 25 mL in 1 VIAL | 1 vial | 2015-02-02 | 2021-07-31 | No | No | Current |