FDA.reportPublic FDA data

Ursodiol

Product NDC
43063-871
11-digit product format
430630871
Labeler code
43063
Product ID
43063-871_3a2162b5-df74-1461-e063-6394a90a5e81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ursosiol
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA210707
Marketing category
ANDA
Marketing start
2018-05-17
Substance
URSADIOL
Active strength
300 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ursodiol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
URSADIOL300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3D089V7L0K
Rxcui858747

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
43063-871-01Ursodiol100 in 1 BOTTLE, PLASTICCAPSULE10014
43063-871-60Ursodiol60 in 1 BOTTLE, PLASTICCAPSULE6014
43063-871-93Ursodiol180 in 1 BOTTLE, PLASTICCAPSULE18014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-871-01EA - Each43063-8714e6c1496-e32f-4e5e-8cf9-51eda2a09acd12018-09-05
43063-871-60EA - Each43063-8712864bd5f-349a-4369-9940-8ed17181903412020-01-03
43063-871-93EA - Each43063-8713cdea6ac-d73e-43e0-8f3d-a3134cb8b25812020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-871URSODIOL (URSOSIOL) CAPSULE [PD-RX PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 3 package rows20240820_d89c9e1e-a115-4a01-9275-74d6cd8cf285.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858747ursodiol 300 MG Oral CapsulePSNd89c9e1e-a115-4a01-9275-74d6cd8cf28514
858747ursodiol 300 MG Oral CapsuleSCDd89c9e1e-a115-4a01-9275-74d6cd8cf28514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-871-0143063087101100 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-01) 100 capsule2018-07-260000-00-00NoNoCurrent
43063-871-604306308716060 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-60) 60 capsule2019-12-100000-00-00NoNoCurrent
43063-871-9343063087193180 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-93) 180 capsule2019-12-100000-00-00NoNoCurrent