FDA.reportPublic FDA data

ursodiol 300 MG Oral Capsule

RxCUI
858747
RxNorm name
ursodiol 300 MG Oral Capsule
Display name
ursodiol 300 MG Oral Capsule
Full name
ursodiol 300 MG Oral Capsule
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:16

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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UrsodiolURSODIOLEpic Pharma, LLCe47b49ca-bde9-448a-bf61-f943c2aa5b8e2023-08-10Warnings, Adverse reactionsExact identifier
rxcui: 858747
UrsodiolURSODIOLActavis Pharma, Inc.a061bb07-a85d-4b08-877f-ce02156f0de72023-07-31Warnings, Adverse reactionsExact identifier
rxcui: 858747
UrsodiolURSODIOLLannett Company, Inc.2e799e93-b5a0-40f7-95c5-b40d8a948a0d2023-07-26Adverse reactionsExact identifier
rxcui: 858747
UrsodiolURSODIOLPuraCap Laboratories, LLC4a161c84-141c-4741-8d69-31a6f3dfd18d2021-10-01Adverse reactionsExact identifier
rxcui: 858747

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 27 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
b2605f6a-b72d-4773-8d2c-39acfe81e424ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]2100Ursodiol Capsules, USP Rx only Prescribing Information SPECIAL NOTE Gallbladder stone dissolution with ursodiol treatment requires months of therapy. Complete dissolution does not occur in all patients and recurrence of stones within 5 years has been observed in up to 50% of patients who do dissolve their stones on bile acid therapy. Patients should be carefully selected for therapy with ursodiol, and alternative therapies should be considered.20260420
011ede7f-bb4d-45f7-8041-9feb4aa2ba7dursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]2100Ursodiol Capsules USP, 300 mg Rx only20231207
e47b49ca-bde9-448a-bf61-f943c2aa5b8eursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]217Ursodiol Capsules USP, 300 mg Rx only20230810
2e799e93-b5a0-40f7-95c5-b40d8a948a0dursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]215Ursodiol Capsules, USP20230726
a061bb07-a85d-4b08-877f-ce02156f0de7ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]214Ursodiol Capsules USP Rx only Prescribing Information20250814
d89c9e1e-a115-4a01-9275-74d6cd8cf285ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]214Ursodiol Capsules, USP Rx only20250717
9ae9412b-36d5-4634-8d5c-cc96110821c0ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]210Ursodiol Capsules, USP 8410001/0225 Rx only Prescribing Information20250619
fff2640b-b704-4303-acae-8647fce58a08ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]29Ursodiol Capsules, USP Rx only20250514
c9aa0223-3ea4-4cb7-b53b-f35e5a04cec7ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]29Ursodiol Capsules USP, 300 mg Rx only20250109
9a6c1928-2d52-4d9a-8e83-f71892a7e98dursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]29Ursodiol Capsules, USP (300 mg) Rx only20230817
1027b933-f64f-4a43-996f-a676b5f72da0ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]28Ursodiol Capsules, USP Rx only20250424
9d7f26d5-d8a9-4610-8d78-80ca3d442a79ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]26Ursodiol Capsules USP, 300 mg Rx only20241219
db43354d-4d77-4241-af4e-5cfa6f6cd296ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]25Ursodiol Capsules USP Rx only20230925
fb317988-a4e3-9c9a-e053-6294a90a5990ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]24Ursodiol Capsules, USP (300 mg) Rx only20260527
bbb1f297-1536-9550-e053-2995a90a0d41ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]24Ursodiol Capsules, USP Rx Only20260112
47beccad-d217-4ae5-9d57-79bf8d0704d8ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]24Ursodiol Capsules, USP Rx only Prescribing Information20240326
631339fc-548d-4cd5-8cf3-60e1590f79f6ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]23Ursodiol Capsules, USP Rx only Prescribing Information SPECIAL NOTE Gallbladder stone dissolution with ursodiol treatment requires months of therapy. Complete dissolution does not occur in all patients and recurrence of stones within 5 years has been observed in up to 50% of patients who do dissolve their stones on bile acid therapy. Patients should be carefully selected for therapy with ursodiol, and alternative therapies should be considered.20250701
6be8e383-37fa-4e0a-b9fc-3976a8be1d2fursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]23Ursodiol Capsules, USP Rx only20240311
6163fc42-5910-4e19-9e32-3d8e81f50128ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]23Ursodiol Capsules, USP Rx only Prescribing Information20240215
31ff3961-3ef1-4ec3-b742-beb4b96de795ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]23Ursodiol Capsules, USP Rx only Prescribing Information SPECIAL NOTE Gallbladder stone dissolution with ursodiol treatment requires months of therapy. Complete dissolution does not occur in all patients and recurrence of stones within 5 years has been observed in up to 50% of patients who do dissolve their stones on bile acid therapy. Patients should be carefully selected for therapy with ursodiol, and alternative therapies should be considered.20231005
74c157f6-c95d-410e-91af-5c38849286c4ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]23Ursodiol Capsules USP Content Updated: November 2014 Rx only 174784 -2 Prescribing Information20160804
00c47258-aef0-53f6-e063-6294a90af96fursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]22Ursodiol Capsules, USP 300mg Rx only20260119
dd0346e2-5ff3-4208-ad88-d09182684603ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]22Ursodiol Capsules, USP Rx only Prescribing Information SPECIAL NOTE Gallbladder stone dissolution with ursodiol treatment requires months of therapy. Complete dissolution does not occur in all patients and recurrence of stones within 5 years has been observed in up to 50% of patients who do dissolve their stones on bile acid therapy. Patients should be carefully selected for therapy with ursodiol, and alternative therapies should be considered.20250701
b636694a-26af-4ed2-8b77-197e82a46de7ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]22Ursodiol Capsules, USP20150313
4a161c84-141c-4741-8d69-31a6f3dfd18dursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]21Ursodiol Capsules USP, 300 mg Rx only20211001
d24c32d6-792d-4d24-b915-746d2499a575ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]21Ursodiol Capsules USP Revised: March 2009 Rx only 17478420120418
35e3194c-ba8b-4b0d-96a6-e2c77e98fda4ursodiol 300 MG Oral Capsule [PSN] · ursodiol 300 MG Oral Capsule [SCD]21Ursodiol Capsules USP Revised: August 2008 Rx only 2000700-0020100614