Fulvestrant

NDC 63323-715 · Fresenius Kabi USA, LLC

Generic nameFulvestrant

Dosage formINJECTION, SOLUTION

RouteINTRAMUSCULAR

Active ingredient(s)FULVESTRANT

Strength50 mg/mL

Pharmacologic classEstrogen Receptor Antagonist [EPC], Estrogen Receptor Antagonists [MoA], Selective Estrogen Receptor Modulators [MoA]

Marketing categoryNDA

Packages

63323-715-05 — 2 SYRINGE, GLASS in 1 CARTON (63323-715-05) / 5 mL in 1 SYRINGE, GLASS (63323-715-01)

J9394 — Injection, fulvestrant (fresenius kabi) not therapeutically equivalent to j9395, 25 mg Medicare Part B payment limit (ASP + 6%): $27.11

FDA lists these products with the same active ingredient.

0143-9022 — Fulvestrant, 0310-0720 — Fulvestrant, 0781-3532 — Fulvestrant, 0781-9055 — Fulvestrant, 16714-070 — fulvestrant, 16729-436 — Fulvestrant, 25021-471 — fulvestrant, 43598-262 — Fulvestrant, 55150-394 — Fulvestrant, 62332-650 — Fulvestrant, 68001-484 — Fulvestrant, 68001-522 — Fulvestrant, 68001-626 — Fulvestrant, 68462-317 — Fulvestrant, 70121-1463 — Fulvestrant, 70700-284 — fulvestrant, 70710-1688 — fulvestrant, 70771-1626 — fulvestrant, 70860-211 — fulvestrant, 71288-555 — Fulvestrant, +3 more

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