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Active ingredient

Dabigatran Etexilate

50 finished FDA listings contain Dabigatran Etexilate as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
DABIGATRAN ETEXILATE, DABIGATRAN ETEXILATE MESYLATE
Dosage forms
Capsule, Capsule, Coated Pellets, Pellet
Routes
Oral
Manufacturers / labelers
18
Strengths listed
110 mg/1 · 150 mg/1 · 20 mg/1 · 30 mg/1 · 40 mg/1 · 50 mg/1 · 75 mg/1
Brand names in FDA listings
Dabigatran, Pradaxa

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1037042

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 022512BOEHRINGER INGELHEIM2010-10-193
ANDA 208040ALKEM LABS LTD2020-03-118
ANDA 207961HETERO LABS LTD III2020-05-066
NDA 214358BOEHRINGER INGELHEIM2021-06-216
ANDA 208070APOTEX2023-12-153
ANDA 213879MSN2024-05-2210
ANDA 215233ALEMBIC2024-06-146
ANDA 208048DR REDDYS2025-01-283
ANDA 208067MYLAN2025-02-032
ANDA 208039AUROBINDO PHARMA2025-05-143

Official labeling on DailyMed

Showing the 12 most recent of 21 labels.

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