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Active ingredient

Pegfilgrastim

15 finished FDA listings contain Pegfilgrastim as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
PEGFILGRASTIM
Dosage forms
Injection, Injection, Solution, Solution
Routes
Subcutaneous
Manufacturers / labelers
10
Strengths listed
4 mg/.4ml · 6 mg/.6ml
Brand names in FDA listings
Armlupeg, Fulphila, Fylnetra, Neulasta, Nyvepria, Stimufend, Udenyca, Ziextenzo

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 338036

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
BLA 125031AMGEN2002-01-312
BLA 761075MYLAN GMBH2018-06-041
BLA 761039COHERUS BIOSCIENCES INC2018-11-026
BLA 761045SANDOZ INC2019-11-041
BLA 761111HOSPIRA INC2020-06-101
BLA 761084KASHIV BIOSCIENCES LLC2022-05-261
BLA 761173FRESENIUS KABI USA2022-09-012
BLA 761212LUPIN LTD2025-11-281

Official labeling on DailyMed

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.