FDA.reportPublic FDA data

Ursodiol

Product NDC
0591-3159
11-digit product format
005913159
Labeler code
0591
Product ID
0591-3159_0e26efeb-af94-41b0-be24-cf5095f9260e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ursodiol
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
NDA019594
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1987-12-31
Substance
URSODIOL
Active strength
300 mg/1
Pharmacologic classes
Bile Acid [EPC], Bile Acids and Salts [CS]
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
URSODIOL300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii724L30Y2QR
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
0591-3159-01Ursodiol100 in 1 BOTTLECAPSULE10014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3159-01EA - Each0591-31592d9e7aa9-cfcf-422a-8be5-8d755594cfaf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
URSODIOLACTIVE INGREDIENT724L30Y2QRURSODIOL CAPSULE [ACTAVIS PHARMA, INC.]6
URSODIOLACTIVE MOIETY724L30Y2QRURSODIOL CAPSULE [ACTAVIS PHARMA, INC.]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675URSODIOL CAPSULE [ACTAVIS PHARMA, INC.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357URSODIOL CAPSULE [ACTAVIS PHARMA, INC.]6
GELATININACTIVE INGREDIENT2G86QN327LURSODIOL CAPSULE [ACTAVIS PHARMA, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30URSODIOL CAPSULE [ACTAVIS PHARMA, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4URSODIOL CAPSULE [ACTAVIS PHARMA, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJURSODIOL CAPSULE [ACTAVIS PHARMA, INC.]6
URSODIOLACTIVE INGREDIENT724L30Y2QRURSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
URSODIOLACTIVE MOIETY724L30Y2QRURSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LURSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJURSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
URSODIOLACTIVE INGREDIENT724L30Y2QRURSODIOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
URSODIOLACTIVE INGREDIENT724L30Y2QRURSODIOL CAPSULE [STAT RX USA LLC]1
URSODIOLACTIVE MOIETY724L30Y2QRURSODIOL CAPSULE [STAT RX USA LLC]1
URSODIOLACTIVE MOIETY724L30Y2QRURSODIOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4URSODIOL CAPSULE [STAT RX USA LLC]1
FERRIC OXIDEINACTIVE INGREDIENT1K09F3G675URSODIOL CAPSULE [STAT RX USA LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675URSODIOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357URSODIOL CAPSULE [STAT RX USA LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357URSODIOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LURSODIOL CAPSULE [STAT RX USA LLC]1
GELATININACTIVE INGREDIENT2G86QN327LURSODIOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30URSODIOL CAPSULE [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30URSODIOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4URSODIOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJURSODIOL CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJURSODIOL CAPSULE [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3159URSODIOL CAPSULE [ACTAVIS PHARMA, INC.]13Current NDC, Legacy NDC, 1 package rows20240612_a061bb07-a85d-4b08-877f-ce02156f0de7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858747ursodiol 300 MG Oral CapsulePSNa061bb07-a85d-4b08-877f-ce02156f0de714
858747ursodiol 300 MG Oral CapsuleSCDa061bb07-a85d-4b08-877f-ce02156f0de714
858747ursodiol 300 MG Oral CapsulePSN74c157f6-c95d-410e-91af-5c38849286c43
858747ursodiol 300 MG Oral CapsuleSCD74c157f6-c95d-410e-91af-5c38849286c43
858747ursodiol 300 MG Oral CapsulePSN00c47258-aef0-53f6-e063-6294a90af96f2
858747ursodiol 300 MG Oral CapsuleSCD00c47258-aef0-53f6-e063-6294a90af96f2
858747ursodiol 300 MG Oral CapsulePSN35e3194c-ba8b-4b0d-96a6-e2c77e98fda41
858747ursodiol 300 MG Oral CapsulePSNd24c32d6-792d-4d24-b915-746d2499a5751
858747ursodiol 300 MG Oral CapsuleSCD35e3194c-ba8b-4b0d-96a6-e2c77e98fda41
858747ursodiol 300 MG Oral CapsuleSCDd24c32d6-792d-4d24-b915-746d2499a5751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-3159-0100591315901100 CAPSULE in 1 BOTTLE (0591-3159-01) 100 capsule1987-12-310000-00-00NoNoCurrent