FDA.reportPublic FDA data

AX Pharmaceutical Corp

Manufacturer
AX Pharmaceutical Corp
Effective date
2017-08-23
Label type
BULK INGREDIENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:48:34

Label at a glance#

ProductAX Pharmaceutical Corp
Active ingredientURSODIOL
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ab35ce6-695f-4d1d-43b4-c16fd63c1674Product name320250317
74e0d644-a165-40ec-b881-1b01c8aa68a4Product name120201006
24881a03-c677-697f-03b9-66e93689fadeProduct name220180724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62157-479-01AX Pharmaceutical Corp25 kg in 1 DRUMPOWDER251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62157-479AX PHARMACEUTICAL CORP (URSODIOL) POWDER [AX PHARMACEUTICAL CORP]11 package rows20170824_ba4eba4a-321d-403d-be38-9f84fd39bf66.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62157-47962157-479-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
URSODIOL724L30Y2QRACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

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 · 40 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UrsodiolURSODIOLMajor Pharmaceuticalsc9aa0223-3ea4-4cb7-b53b-f35e5a04cec72025-01-09Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLPuraCap Laboratories, LLC9d7f26d5-d8a9-4610-8d78-80ca3d442a792024-12-19Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLBryant Ranch Prepack46cfd68f-9a6e-4a00-a3e7-11d130b571fe2024-10-03Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLBryant Ranch Prepackbe811c61-5f48-4b03-94b6-e6941b5956212024-05-31Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLZydus Pharmaceuticals (USA) Inc.47beccad-d217-4ae5-9d57-79bf8d0704d82024-03-26Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLZydus Pharmaceuticals (USA) Inc.55c1556b-8b47-479a-979b-fd61bdd27c7f2024-03-22Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLLaurus Labs Limited6be8e383-37fa-4e0a-b9fc-3976a8be1d2f2024-03-11Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLZydus Lifesciences Limited6163fc42-5910-4e19-9e32-3d8e81f501282024-02-15Warnings, Adverse reactionsName fallback
generic name: URSODIOL
Ursodiol 200 mgURSODIOLFH2 Pharma LLC476179dc-b410-4305-881b-4705117656472023-12-31Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLBryant Ranch Prepack5e6ced5f-b8ef-4e6b-a7c1-730bac650c5b2023-12-07Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLBryant Ranch Prepack011ede7f-bb4d-45f7-8041-9feb4aa2ba7d2023-12-07Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLChartwell RX, LLC31ff3961-3ef1-4ec3-b742-beb4b96de7952023-10-05Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLVGYAAN Pharmaceuticals LLCdb43354d-4d77-4241-af4e-5cfa6f6cd2962023-09-25Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLEpic Pharma, LLCe47b49ca-bde9-448a-bf61-f943c2aa5b8e2023-08-10Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLActavis Pharma, Inc.a061bb07-a85d-4b08-877f-ce02156f0de72023-07-31Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLLannett Company, Inc.2e799e93-b5a0-40f7-95c5-b40d8a948a0d2023-07-26Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLZydus Lifesciences Limited792d8b51-3815-44d2-a20e-b494a9d0e0552023-06-15Warnings, Adverse reactionsName fallback
generic name: URSODIOL
Reltone 200 mgURSODIOLIntra-Sana Laboratoriesd1c28b0b-8f3c-4d60-8182-24a4c659d7622023-01-16Adverse reactionsName fallback
generic name: URSODIOL
Urso 250URSODIOLAllergan, Inc.e8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a612023-01-12Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLPuraCap Laboratories, LLC4a161c84-141c-4741-8d69-31a6f3dfd18d2021-10-01Adverse reactionsName fallback
generic name: URSODIOL

Reported adverse events (FAERS/openFDA)#

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