GEMCITABINE
- Product NDC
- 50742-496
- 11-digit product format
- 507420496
- Labeler code
- 50742
- Product ID
- 50742-496_cbc8b03c-7da2-4b8f-96ec-2862a224f434
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gemcitabine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Ingenus Pharmaceuticals, LLC
- Application
- ANDA210383
- Marketing category
- ANDA
- Marketing start
- 2019-02-26
- Marketing end
- 0000-00-00
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50742-496 | GEMCITABINE INJECTION, SOLUTION [INGENUS PHARMACEUTICALS, LLC] | 7 | Legacy NDC | 20230706_a15f5d83-6ba1-4891-9e26-ce23ddaf68c7.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50742-496-26 | 50742049626 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50742-496-26) > 26.3 mL in 1 VIAL, SINGLE-DOSE | 2019-02-26 | 0000-00-00 | No | No | Current |