URSODIOL Pharmacologic Class Indexing

Class set ID
002174ab-2f7b-41ee-9102-61d680293ade
Version
2
Effective date
20180813
Type
Indexing - Pharmacologic Class

Mapped DailyMed Labels#

Label, Manufacturer, Effective table
LabelManufacturerEffectiveSPL version
Ursodiol Capsules, USP (300 mg) Rx onlyGolden State Medical Supply, Inc.202605274
Ursodiol 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.Bryant Ranch Prepack20260420100
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: 1997Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited2026012713
Ursodiol Capsules, USP 300mg Rx onlyAvKARE202601192
Ursodiol 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: 1997AvKARE202601192
Ursodiol Capsules, USP Rx OnlyAvPAK202601124
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: 1997Cardinal Health 107, LLC202512053
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: 1997American Health Packaging202511134
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: 1997Major Pharmaceuticals202510316
Ursodiol Capsules USP Rx only Prescribing InformationActavis Pharma, Inc. | Watson Pharma Private Limited2025081414
Ursodiol 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.Aurobindo Pharma Limited | APL HEALTHCARE LIMITED202507013
Ursodiol 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.NorthStar Rx LLC | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED202507012
Ursodiol Capsules, USP 8410001/0225 Rx only Prescribing InformationAmerican Health Packaging2025061910
Ursodiol Capsules, USP Rx onlyAmneal Pharmaceuticals NY LLC202504248
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: 1997Strides Pharma Science Limited | Strides Pharma Global Pte. Ltd.2025031310
Ursodiol Capsules USP, 300 mg Rx onlyMajor Pharmaceuticals202501099
Ursodiol Capsules USP, 300 mg Rx onlyPuraCap Laboratories, LLC | Epic Pharma, LLC202412196
Ursodiol CapsuleLGM PHARMA SOLUTIONS, LLC202411263
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: 1997Bryant Ranch Prepack20241003104
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: 1997Bryant Ranch Prepack20240531104
Ursodiol Capsules, USP Rx only Prescribing InformationZydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited202403264
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: 1997Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited202403227
Ursodiol Capsules, USP Rx onlyLaurus Labs Limited | Laurus Labs Limited (VSP2)202403113
Ursodiol Capsules, USP Rx only Prescribing InformationZydus Lifesciences Limited202402153
Ursodiol Capsules, USP Rx OnlyFH2 Pharma LLC | LGM Pharma Solutions LLC202312313
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: 1997Bryant Ranch Prepack20231207105
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: 1997Bryant Ranch Prepack20231207102
Ursodiol Capsules USP, 300 mg Rx onlyBryant Ranch Prepack20231207100
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: 1997Endo USA, Inc.2023112212
Ursodiol 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.Chartwell RX, LLC202310053
Ursodiol Capsules USP Rx onlyVGYAAN Pharmaceuticals LLC | Aizant Drug Research Solutions PVT LTD202309255
Ursodiol Capsules, USP (300 mg) Rx onlyStrides Pharma Science Limited202308179
Ursodiol Capsules USP, 300 mg Rx onlyEpic Pharma, LLC2023081017
Ursodiol Capsules, USPLannett Company, Inc.2023072615
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: 1997Zydus Lifesciences Limited202306155
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 USP, for oral use Initial U.S. Approval: 1997BluePoint Laboratories | Glenmark Pharmaceuticals Inc.,USA | Glenmark Pharmaceuticals Limited202305083
RELTONE™ ( ursodiol capsules, USP )Intra-Sana Laboratories | LGM Pharma Solutions, LLC202301162
These 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: 1997Allergan, Inc.2023011219
Ursodiol Capsules USP, 300 mg Rx onlyPuraCap Laboratories, LLC | Epic Pharma, LLC202110011
Ursodiol Capsules, USP Rx OnlyNexgen Pharma, Inc | Nexgen Pharma, Inc.202005155
7b4ab2b8-bdf9-9635-e053-2a91aa0acb4cOASIS TRADING201811221
7aa650ea-167b-cdd8-e053-2991aa0a7896OASIS TRADING201811192
Ursodiol Capsules USP Content Updated: November 2014 Rx only 174784 -2 Prescribing InformationCarilion Materials Management201608043
These 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: 1997Avera McKennan Hospital201512081
Ursodiol Capsules, USPMarlex Pharmaceuticals Inc201503132
Ursodiol Capsules USP Revised: March 2009 Rx only 174784Physicians Total Care, Inc.201204181
Drug FactsLG Household and Healthcare, Inc.201006214
Ursodiol Capsules USP Revised: August 2008 Rx only 2000700-00STAT RX USA LLC201006141