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Active ingredient

Adalimumab

47 finished FDA listings contain Adalimumab as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADBM, ADALIMUMAB-BWWD, ADALIMUMAB-FKJP
Dosage forms
Injection, Injection, Solution, Solution
Routes
Subcutaneous
Manufacturers / labelers
9
Strengths listed
10 mg/.1ml · 10 mg/.2ml · 20 mg/.2ml · 20 mg/.4ml · 40 mg/.4ml · 40 mg/.8ml · 80 mg/.8ml
Brand names in FDA listings
Adalimumab, Amjevita, Hadlima, Hyrimoz, Yusimry

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 327361

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 761024AMGEN INC2016-09-2318
BLA 761071SANDOZ INC2018-10-3015
BLA 761059SAMSUNG BIOEPIS CO LTD2019-07-2310
BLA 761216EMERGE BIOSCIENCE PTE LTD2021-12-174

Official labeling on DailyMed

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