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Active ingredient

Ursodeoxycholate

51 finished FDA listings contain Ursodeoxycholate as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
URSODIOL
Dosage forms
Capsule, Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
28
Strengths listed
150 mg/1 · 200 mg/1 · 250 mg/1 · 300 mg/1 · 400 mg/1 · 500 mg/1
Brand names in FDA listings
Reltone 200 Mg, Reltone 400 Mg, Urso 250, Urso Forte, Ursodiol 200 Mg, Ursodiol 400 Mg, Ursolign

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 62427

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 019594TEVA BRANDED PHARM1987-12-312
NDA 020675ABBVIE1997-12-102
ANDA 075517EPIC PHARMA2000-03-145
ANDA 079082LANNETT CO INC2008-12-152
ANDA 090801GLENMARK PHARMS LTD2011-07-124
ANDA 202540PH HEALTH2013-02-149
ANDA 211301AMNEAL PHARMS CO2018-10-162
ANDA 211145ZYDUS LIFESCIENCES2018-10-305
ANDA 213200RISING2020-02-121
ANDA 205789LGM PHARMA2020-05-086
ANDA 213555CHARTWELL RX2020-08-171
ANDA 213504STRIDES PHARMA2020-08-202
ANDA 214295ZYDUS LIFESCIENCES2020-10-163
ANDA 210344STRIDES PHARMA2021-01-223
ANDA 214329PHARMAZONE2021-07-281
ANDA 214849AUROBINDO PHARMA LTD2022-11-283

Official labeling on DailyMed

Showing the 12 most recent of 41 labels.

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