Gemcitabine

NDC 71288-117 · Meitheal Pharmaceuticals Inc.

FDA carries 2 listing records for this NDC; the most recent is shown.

Generic nameGemcitabine hydrochloride

Dosage formINJECTION, SOLUTION

RouteINTRAVENOUS

Active ingredient(s)GEMCITABINE HYDROCHLORIDE

Strength38 mg/mL

Pharmacologic classNucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]

Marketing categoryANDA

Packages

71288-117-91 — 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-91) / 5.26 mL in 1 VIAL, SINGLE-DOSE

71288-117-92 — 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-92) / 26.3 mL in 1 VIAL, SINGLE-DOSE

71288-117-93 — 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-93) / 52.6 mL in 1 VIAL, SINGLE-DOSE

71288-117-06 — 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-06) / 5.26 mL in 1 VIAL, SINGLE-DOSE

71288-117-28 — 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-28) / 26.3 mL in 1 VIAL, SINGLE-DOSE

71288-117-54 — 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-54) / 52.6 mL in 1 VIAL, SINGLE-DOSE

J9201 — Injection, gemcitabine hydrochloride, not otherwise specified, 200 mg Medicare Part B payment limit (ASP + 6%): $2.88

FDA lists these products with the same active ingredient.

25021-239 — gemcitabine, 55111-686 — gemcitabine, 55111-687 — gemcitabine, 63323-102 — GEMCITABINE, 63323-125 — GEMCITABINE, 63323-126 — GEMCITABINE, 67457-616 — GEMCITABINE HYDROCHLORIDE, 67457-617 — GEMCITABINE HYDROCHLORIDE, 67457-618 — GEMCITABINE HYDROCHLORIDE, 68001-342 — GEMCITABINE, 68001-348 — GEMCITABINE, 68001-359 — GEMCITABINE, 68083-148 — gemcitabine hydrochloride, 68083-149 — gemcitabine hydrochloride, 71288-113 — GEMCITABINE HYDROCHLORIDE, 71288-114 — GEMCITABINE HYDROCHLORIDE, 82511-008 — Gemcitabine hydrochloride, 82511-009 — Gemcitabine hydrochloride, 83831-123 — Gemcitabine, 83831-124 — Gemcitabine, +13 more

From the FDA National Drug Code Directory, retrieved 2026-08-24. Product listings are submitted by labelers; FDA does not verify them.