Skip to content
LookupMeds

Active ingredient

Nintedanib

24 finished FDA listings contain Nintedanib as their only active ingredient.

See all listingsCompare with another medication

FDA NDC Directory

Ingredient names as written by FDA
NINTEDANIB, NINTEDANIB ESYLATE
Dosage forms
Capsule
Routes
Oral
Manufacturers / labelers
12
Strengths listed
100 mg/1 · 150 mg/1
Brand names in FDA listings
Nintedanib Capsules, 100 Mg And 150 Mg, Ofev

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1592737

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
NDA 205832BOEHRINGER INGELHEIM2014-10-152
ANDA 219819DEXCEL2026-04-024
ANDA 219227APOTEX2026-04-022
ANDA 219283DR REDDYS2026-04-022
ANDA 212609CIPLA2026-04-024
ANDA 216915SANDOZ2026-04-022
ANDA 218472HUMANWELL PURACAP2026-07-092
ANDA 212555GLENMARK PHARMS LTD2026-07-094
ANDA 219926MACLEODS PHARMS2026-08-032

Official labeling on DailyMed

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