United States · FDA National Drug Code directory
Gemcitabine
A source-listed medicine record.
Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.
Medicine identity
- Source reference
- 71288-117_be3f7738-022f-4b20-94f3-40f5337997c1
- Product NDC
- 71288-117
- Form
- INJECTION, SOLUTION
- Composition / generic term
- Gemcitabine hydrochloride
- Labeler
- Meitheal Pharmaceuticals Inc.
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20201211
- Source listing expiry
- 20261231
Source-listed ingredients
- GEMCITABINE HYDROCHLORIDE — 38 mg/mL
These values do not establish equivalence or a dose recommendation.
Packages
- 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-91) / 5.26 mL in 1 VIAL, SINGLE-DOSE · 71288-117-91
- 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-92) / 26.3 mL in 1 VIAL, SINGLE-DOSE · 71288-117-92
- 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-93) / 52.6 mL in 1 VIAL, SINGLE-DOSE · 71288-117-93
Source and coverage
Open FDA National Drug Code directory →
Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.
Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.
Browse United States records →