INFUGEM
- Product NDC
- 62756-533
- 11-digit product format
- 627560533
- Labeler code
- 62756
- Product ID
- 62756-533_88ff4968-c7f9-4cf5-8cd0-4793df7e8313
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gemcitabine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- NDA208313
- Marketing category
- NDA
- Marketing start
- 2018-10-01
- Marketing end
- 0000-00-00
- Substance
- GEMCITABINE HYDROCHLORIDE
- Active strength
- 10 mg/mL
- 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62756-533-60 | 62756053360 | 1 POUCH in 1 CARTON (62756-533-60) > 1 BAG in 1 POUCH > 180 mL in 1 BAG | 1 pouch | 2018-10-01 | 0000-00-00 | No | No | Current |