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Active ingredient

Rivaroxaban

43 finished FDA listings contain Rivaroxaban as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
RIVAROXABAN
Dosage forms
For Suspension, Granule, For Suspension, Tablet, Tablet, Coated, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
23
Strengths listed
10 mg/1 · 15 mg/1 · 155 mg/1 · 2.5 mg/1 · 20 mg/1
Brand names in FDA listings
Xarelto

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1114195

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 022406JANSSEN PHARMS2011-07-0111
NDA 215859JANSSEN PHARMS2021-12-201
ANDA 208557TARO2025-03-031
ANDA 208555LUPIN2025-03-031
ANDA 208544AUROBINDO PHARMA LTD2025-04-101
ANDA 217810APOTEX2025-05-021
ANDA 216995AIPING PHARM INC2025-05-143
ANDA 213114MACLEODS PHARMS2025-05-142
ANDA 208534DR REDDYS2025-05-141
ANDA 210301ALEMBIC2025-05-148
ANDA 219332ASCENT PHARMS INC2025-05-142
ANDA 218502ALKEM LABS LTD2025-06-261
ANDA 218117SCIEGEN PHARMS2025-07-312
ANDA 218445REGCON HOLDINGS2025-08-115
ANDA 218195LUPIN2025-09-251
ANDA 208546MSN2025-10-241
ANDA 208334MICRO LABS2026-06-301

Official labeling on DailyMed

Showing the 12 most recent of 27 labels.

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