Topotecan Hydrochloride

NDC 63323-762 · Fresenius Kabi USA, LLC

Generic nameTOPOTECAN HYDROCHLORIDE

Dosage formINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

RouteINTRAVENOUS

Active ingredient(s)TOPOTECAN HYDROCHLORIDE

Strength4 mg/4mL

Pharmacologic classTopoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]

Marketing categoryANDA

Packages

63323-762-10 — 1 VIAL in 1 BOX (63323-762-10) / 4 mL in 1 VIAL

J9351 — Injection, topotecan, 0.1 mg Medicare Part B payment limit (ASP + 6%): $2.76

FDA lists these products with the same active ingredient.

0078-0674 — topotecan hydrochloride, 0409-0302 — TOPOTECAN, 16729-151 — topotecan hydrochloride, 45963-615 — Topotecan hydrochloride, 66758-101 — topotecan, 66758-102 — topotecan

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