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Active ingredient

Vedolizumab

3 finished FDA listings contain Vedolizumab as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
VEDOLIZUMAB
Dosage forms
Injection, Powder, Lyophilized, For Solution, Injection, Solution
Routes
Intravenous, Subcutaneous
Manufacturers / labelers
1
Strengths listed
108 mg/.68ml · 300 mg/5ml
Brand names in FDA listings
Entyvio, Entyvio Pen

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1538097

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 125476TAKEDA PHARMS USA2014-05-201
BLA 761133TAKEDA PHARMS USA2023-09-272

Official labeling on DailyMed

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