FDA.reportPublic FDA data

Ursodiol

Product NDC
0591-2998
11-digit product format
005912998
Labeler code
0591
Product ID
0591-2998_3ca902a9-d8c3-4c4b-a49f-efc62cf2028a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ursodiol
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
NDA020675
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1997-12-10
Marketing end
2026-05-31
Substance
URSODIOL
Active strength
250 mg/1
Pharmacologic classes
Bile Acid [EPC], Bile Acids and Salts [CS]
NDC exclude flag
No
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ab35ce6-695f-4d1d-43b4-c16fd63c1674Product name320250317
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
74e0d644-a165-40ec-b881-1b01c8aa68a4Product name120201006
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
24881a03-c677-697f-03b9-66e93689fadeProduct name220180724
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-2998-01Ursodiol100 in 1 BOTTLETABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2998-01EA - Each0591-2998caf44577-94ac-4345-8fce-9f5e9bc307ad12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
URSODIOLACTIVE INGREDIENT724L30Y2QRURSODIOL TABLET [ACTAVIS PHARMA, INC.]2
URSODIOLACTIVE MOIETY724L30Y2QRURSODIOL TABLET [ACTAVIS PHARMA, INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZURSODIOL TABLET [ACTAVIS PHARMA, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UURSODIOL TABLET [ACTAVIS PHARMA, INC.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNURSODIOL TABLET [ACTAVIS PHARMA, INC.]2
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYURSODIOL TABLET [ACTAVIS PHARMA, INC.]2
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BURSODIOL TABLET [ACTAVIS PHARMA, INC.]2
HYDROGEN PEROXIDEINACTIVE INGREDIENTBBX060AN9VURSODIOL TABLET [ACTAVIS PHARMA, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOURSODIOL TABLET [ACTAVIS PHARMA, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30URSODIOL TABLET [ACTAVIS PHARMA, INC.]2
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PURSODIOL TABLET [ACTAVIS PHARMA, INC.]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BURSODIOL TABLET [ACTAVIS PHARMA, INC.]2
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQURSODIOL TABLET [ACTAVIS PHARMA, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JURSODIOL TABLET [ACTAVIS PHARMA, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2URSODIOL TABLET [ACTAVIS PHARMA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2998URSODIOL TABLET [ACTAVIS PHARMA, INC.]8Current NDC, Legacy NDC, 1 package rows20241011_0a7c1ae6-4878-43e7-9026-073f74af64c0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-2998-0100591299801100 TABLET in 1 BOTTLE (0591-2998-01) 100 tablet1997-12-102026-05-31NoNoCurrent