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 1 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UrsodiolURSODIOLAvPAK5693d709-e894-0144-e063-6294a90a99db2026-07-27Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLBluePoint Laboratoriesa3c98080-0a4d-4a93-8dcb-02ab8533050b2026-07-14Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLBryant Ranch Prepackf527a42c-a6ec-4a0b-a3d8-6c7eba38733c2026-07-13Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLMajor Pharmaceuticalse1f6abfd-2158-4824-b53d-717fbe6de3f92026-06-29Warnings, Adverse reactionsName fallback
generic name: URSODIOL
URSOLIGNURSODIOLPangea Pharmaceuticals, LLC3617fb7a-1f57-4276-bebb-ae6ba4252d4e2026-06-12Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLPar Health USA, LLC1a3a8942-94d4-4292-bf74-0a67d92acb902026-06-12Warnings, Adverse reactionsName fallback
generic name: URSODIOL
URSODIOLURSODIOLGolden State Medical Supply, Inc.fb317988-a4e3-9c9a-e053-6294a90a59902026-05-27Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLBryant Ranch Prepackb2605f6a-b72d-4773-8d2c-39acfe81e4242026-04-20Warnings, Adverse reactionsName fallback
generic name: URSODIOL
URSODIOLURSODIOLStrides Pharma Science Limited9a6c1928-2d52-4d9a-8e83-f71892a7e98d2026-03-06Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLGlenmark Pharmaceuticals Inc., USAfb79b62a-b450-4d7a-be28-5ee4d174fd582026-01-27Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLAvKARE00c47258-aef0-53f6-e063-6294a90af96f2026-01-19Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLAvKARE0c7e1aa2-704c-435d-e063-6394a90a2d082026-01-19Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLAvPAKbbb1f297-1536-9550-e053-2995a90a0d412026-01-12Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLCardinal Health 107, LLC61dcaec8-3acb-4ef0-afde-65a66e99afa72025-12-05Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLAmerican Health Packaginga3a90d07-0dac-48fc-829a-759d9333843e2025-11-13Warnings, Adverse reactionsName fallback
generic name: URSODIOL
URSODIOLURSODIOLStrides Pharma Science Limited9d666bbc-98c4-445f-a5a2-cad1bcccde4e2025-08-10Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLAurobindo Pharma Limited631339fc-548d-4cd5-8cf3-60e1590f79f62025-07-01Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLNorthStar Rx LLCdd0346e2-5ff3-4208-ad88-d091826846032025-07-01Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLAmerican Health Packaging9ae9412b-36d5-4634-8d5c-cc96110821c02025-06-19Warnings, Adverse reactionsName fallback
generic name: URSODIOL
UrsodiolURSODIOLAmneal Pharmaceuticals NY LLC1027b933-f64f-4a43-996f-a676b5f72da02025-04-24Adverse reactionsName fallback
generic name: URSODIOL

Reported adverse events (FAERS/openFDA)#

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