GEMCITABINE
- Product NDC
- 16729-391
- 11-digit product format
- 167290391
- Labeler code
- 16729
- Product ID
- 16729-391_ecb6a530-5574-6877-e053-2a95a90aa57f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GEMCITABINE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Accord Healthcare Inc.
- Application
- NDA209604
- Marketing category
- NDA
- Marketing start
- 2018-01-24
- Marketing end
- 0000-00-00
- Substance
- GEMCITABINE HYDROCHLORIDE
- Active strength
- 100 mg/mL
- 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-391 | GEMCITABINE INJECTION, SOLUTION [ACCORD HEALTHCARE INC.] | 8 | Legacy NDC | 20240926_5a335d36-408b-478f-9563-4bc140b69bb6.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16729-391-30 | 16729039130 | 2 mL in 1 VIAL, MULTI-DOSE (16729-391-30) | 2 ml | 2018-01-24 | 0000-00-00 | No | No | Current |