GEMCITABINE

NDC 63323-125 · Fresenius Kabi USA, LLC

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

Generic nameGEMCITABINE

Dosage formINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

RouteINTRAVENOUS

Active ingredient(s)GEMCITABINE HYDROCHLORIDE

Strength1 g/25mL

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

Marketing categoryANDA

Packages

63323-125-94 — 1 VIAL, SINGLE-DOSE in 1 BOX (63323-125-94) / 25 mL in 1 VIAL, SINGLE-DOSE

63323-125-53 — 1 VIAL, SINGLE-DOSE in 1 BOX (63323-125-53) / 25 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.

0409-0186 — GEMCITABINE, 0409-0187 — GEMCITABINE, 16714-909 — GEMCITABINE HYDROCHLORIDE, 16714-930 — GEMCITABINE HYDROCHLORIDE, 25021-234 — gemcitabine hydrochloride, 25021-235 — gemcitabine hydrochloride, 25021-239 — gemcitabine, 55111-686 — gemcitabine, 55111-687 — gemcitabine, 63323-102 — 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, +13 more

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