FDA.reportPublic FDA data

ursodiol 250 MG Oral Tablet

RxCUI
858751
RxNorm name
ursodiol 250 MG Oral Tablet
Display name
ursodiol 250 MG Oral Tablet
Full name
ursodiol 250 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UrsodiolURSODIOLBluePoint Laboratoriesa3c98080-0a4d-4a93-8dcb-02ab8533050b2026-07-14Warnings, Adverse reactionsExact identifier
rxcui: 858751
UrsodiolURSODIOLBryant Ranch Prepackf527a42c-a6ec-4a0b-a3d8-6c7eba38733c2026-07-13Warnings, Adverse reactionsExact identifier
rxcui: 858751
UrsodiolURSODIOLMajor Pharmaceuticalse1f6abfd-2158-4824-b53d-717fbe6de3f92026-06-29Warnings, Adverse reactionsExact identifier
rxcui: 858751
UrsodiolURSODIOLPar Health USA, LLC1a3a8942-94d4-4292-bf74-0a67d92acb902026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 858751
UrsodiolURSODIOLGlenmark Pharmaceuticals Inc., USAfb79b62a-b450-4d7a-be28-5ee4d174fd582026-01-27Warnings, Adverse reactionsExact identifier
rxcui: 858751
UrsodiolURSODIOLCardinal Health 107, LLC61dcaec8-3acb-4ef0-afde-65a66e99afa72025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 858751
UrsodiolURSODIOLAmerican Health Packaginga3a90d07-0dac-48fc-829a-759d9333843e2025-11-13Warnings, Adverse reactionsExact identifier
rxcui: 858751
URSODIOLURSODIOLStrides Pharma Science Limited9d666bbc-98c4-445f-a5a2-cad1bcccde4e2025-08-10Warnings, Adverse reactionsExact identifier
rxcui: 858751
UrsodiolURSODIOLBryant Ranch Prepack46cfd68f-9a6e-4a00-a3e7-11d130b571fe2024-10-03Warnings, Adverse reactionsExact identifier
rxcui: 858751
UrsodiolURSODIOLZydus Pharmaceuticals (USA) Inc.55c1556b-8b47-479a-979b-fd61bdd27c7f2024-03-22Warnings, Adverse reactionsExact identifier
rxcui: 858751
UrsodiolURSODIOLZydus Lifesciences Limited792d8b51-3815-44d2-a20e-b494a9d0e0552023-06-15Warnings, Adverse reactionsExact identifier
rxcui: 858751
Urso 250URSODIOLAllergan, Inc.e8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a612023-01-12Warnings, Adverse reactionsExact identifier
rxcui: 858751

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 13 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
46cfd68f-9a6e-4a00-a3e7-11d130b571feursodiol 250 MG Oral Tablet [PSN] · ursodiol 250 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: 199720241003
f527a42c-a6ec-4a0b-a3d8-6c7eba38733cursodiol 250 MG Oral Tablet [PSN] · ursodiol 250 MG Oral Tablet [SCD]2102These 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
e8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a61ursodiol 250 MG Oral Tablet [PSN] · ursodiol 250 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 250 MG Oral Tablet [PSN] · ursodiol 250 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 250 MG Oral Tablet [PSN] · ursodiol 250 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 250 MG Oral Tablet [PSN] · ursodiol 250 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 250 MG Oral Tablet [PSN] · ursodiol 250 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
e1f6abfd-2158-4824-b53d-717fbe6de3f9ursodiol 250 MG Oral Tablet [PSN] · ursodiol 250 MG Oral Tablet [SCD]26These 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: 199720251031
792d8b51-3815-44d2-a20e-b494a9d0e055ursodiol 250 MG Oral Tablet [PSN] · ursodiol 250 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
a3a90d07-0dac-48fc-829a-759d9333843eursodiol 250 MG Oral Tablet [PSN] · ursodiol 250 MG Oral Tablet [SCD]24These 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: 199720251113
61dcaec8-3acb-4ef0-afde-65a66e99afa7ursodiol 250 MG Oral Tablet [PSN] · ursodiol 250 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, for oral use Initial U.S. Approval: 199720251205
a3c98080-0a4d-4a93-8dcb-02ab8533050bursodiol 250 MG Oral Tablet [PSN] · ursodiol 250 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
56eb5083-38b8-4b09-9e42-fb363ca70809ursodiol 250 MG Oral Tablet [PSN] · ursodiol 250 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use ursodiol tablets safely and effectively. See full prescribing information for ursodiol tablets. Initial U.S. Approval: 199720151208