FDA.reportPublic FDA data

ursodiol 500 MG Oral Tablet

RxCUI
858733
RxNorm name
ursodiol 500 MG Oral Tablet
Display name
ursodiol 500 MG Oral Tablet
Full name
ursodiol 500 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:00

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UrsodiolURSODIOLBluePoint Laboratoriesa3c98080-0a4d-4a93-8dcb-02ab8533050b2026-07-14Warnings, Adverse reactionsExact identifier
rxcui: 858733
UrsodiolURSODIOLPar Health USA, LLC1a3a8942-94d4-4292-bf74-0a67d92acb902026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 858733
UrsodiolURSODIOLGlenmark Pharmaceuticals Inc., USAfb79b62a-b450-4d7a-be28-5ee4d174fd582026-01-27Warnings, Adverse reactionsExact identifier
rxcui: 858733
UrsodiolURSODIOLAvKARE0c7e1aa2-704c-435d-e063-6394a90a2d082026-01-19Warnings, Adverse reactionsExact identifier
rxcui: 858733
URSODIOLURSODIOLStrides Pharma Science Limited9d666bbc-98c4-445f-a5a2-cad1bcccde4e2025-08-10Warnings, Adverse reactionsExact identifier
rxcui: 858733
UrsodiolURSODIOLBryant Ranch Prepackbe811c61-5f48-4b03-94b6-e6941b5956212024-05-31Warnings, Adverse reactionsExact identifier
rxcui: 858733
UrsodiolURSODIOLZydus Pharmaceuticals (USA) Inc.55c1556b-8b47-479a-979b-fd61bdd27c7f2024-03-22Warnings, Adverse reactionsExact identifier
rxcui: 858733
UrsodiolURSODIOLBryant Ranch Prepack5e6ced5f-b8ef-4e6b-a7c1-730bac650c5b2023-12-07Warnings, Adverse reactionsExact identifier
rxcui: 858733
UrsodiolURSODIOLZydus Lifesciences Limited792d8b51-3815-44d2-a20e-b494a9d0e0552023-06-15Warnings, Adverse reactionsExact identifier
rxcui: 858733
Urso 250URSODIOLAllergan, Inc.e8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a612023-01-12Warnings, Adverse reactionsExact identifier
rxcui: 858733

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 10 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
5e6ced5f-b8ef-4e6b-a7c1-730bac650c5bursodiol 500 MG Oral Tablet [PSN] · ursodiol 500 MG Oral Tablet [SCD]2105These highlights do not include all the information needed to use URSODIOL TABLETS safely and effectively. See full prescribing information for URSODIOL TABLETS. URSODIOL tablets, for oral use Initial U.S. Approval: 199720231207
be811c61-5f48-4b03-94b6-e6941b595621ursodiol 500 MG Oral Tablet [PSN] · ursodiol 500 MG Oral Tablet [SCD]2104These highlights do not include all the information needed to use URSODIOL TABLETS safely and effectively. See full prescribing information for URSODIOL TABLETS. URSODIOL tablets, for oral use Initial U.S. Approval: 199720240531
e8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a61ursodiol 500 MG Oral Tablet [PSN] · ursodiol 500 MG Oral Tablet [SCD]219These highlights do not include all the information needed to use URSO 250 and URSO FORTE safely and effectively. See full prescribing information for URSO 250 and URSO FORTE. URSO 250 ® (ursodiol) tablets, for oral use URSO F ORTE ® (ursodiol) tablets, for oral use Initial U.S. Approval: 199720230112
fb79b62a-b450-4d7a-be28-5ee4d174fd58ursodiol 500 MG Oral Tablet [PSN] · ursodiol 500 MG Oral Tablet [SCD]213These highlights do not include all the information needed to use URSODIOL TABLETS safely and effectively. See full prescribing information for URSODIOL TABLETS. URSODIOL tablets, for oral use Initial U.S. Approval: 199720260127
1a3a8942-94d4-4292-bf74-0a67d92acb90ursodiol 500 MG Oral Tablet [PSN] · ursodiol 500 MG Oral Tablet [SCD]212These highlights do not include all the information needed to use URSODIOL TABLETS safely and effectively. See full prescribing information for URSODIOL TABLETS. URSODIOL tablets, for oral use Initial U.S. Approval: 199720231122
9d666bbc-98c4-445f-a5a2-cad1bcccde4eursodiol 500 MG Oral Tablet [PSN] · ursodiol 500 MG Oral Tablet [SCD]210These highlights do not include all the information needed to use URSODIOL TABLETS safely and effectively. See full prescribing information for URSODIOL TABLETS. URSODIOL tablets, for oral use Initial U.S. Approval: 199720250313
55c1556b-8b47-479a-979b-fd61bdd27c7fursodiol 500 MG Oral Tablet [PSN] · ursodiol 500 MG Oral Tablet [SCD]27These highlights do not include all the information needed to use URSODIOL TABLETS safely and effectively. See full prescribing information for URSODIOL TABLETS. Ursodiol tablets, for oral use Initial U.S. Approval: 199720240322
792d8b51-3815-44d2-a20e-b494a9d0e055ursodiol 500 MG Oral Tablet [PSN] · ursodiol 500 MG Oral Tablet [SCD]25These highlights do not include all the information needed to use URSODIOL TABLETS safely and effectively. See full prescribing information for URSODIOL TABLETS. Ursodiol tablets, for oral use Initial U.S. Approval: 199720230615
a3c98080-0a4d-4a93-8dcb-02ab8533050bursodiol 500 MG Oral Tablet [PSN] · ursodiol 500 MG Oral Tablet [SCD]23These highlights do not include all the information needed to use URSODIOL TABLETS safely and effectively. See full prescribing information for URSODIOL TABLETS. URSODIOL Tablets USP, for oral use Initial U.S. Approval: 199720230508
0c7e1aa2-704c-435d-e063-6394a90a2d08ursodiol 500 MG Oral Tablet [PSN] · ursodiol 500 MG Oral Tablet [SCD]22Ursodiol Tablet, USP Rx only These highlights do not include all the information needed to use URSODIOL TABLETS safely and effectively. See full prescribing information for URSODIOL TABLETS. URSODIOL tablets, for oral use Initial U.S. Approval: 199720260119