FDA.reportPublic FDA data

Urso 250

Product NDC
58914-785
11-digit product format
589140785
Labeler code
58914
Product ID
58914-785_06904c03-cea9-4532-8e27-7f2246be613b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ursodiol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA020675
Marketing category
NDA
Marketing start
1997-12-10
Substance
URSODIOL
Active strength
250 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
Urso 250
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
URSODIOL250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii724L30Y2QR
Rxcui858733, 858735, 858751, 858752

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
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
58914-785-10Urso 250100 in 1 BOTTLETABLET, FILM COATED10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58914-785-10EA - Each58914-785e55cc823-7ee6-4a9a-8ed8-2d7702b4cd0412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
UrsodiolACTIVE INGREDIENT724L30Y2QRURSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.]7
UrsodiolACTIVE MOIETY724L30Y2QRURSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.]7
Carnauba waxINACTIVE INGREDIENTR12CBM0EIZURSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.]7
Cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UURSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.]7
Dibutyl sebacateINACTIVE INGREDIENT4W5IH7FLNYURSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.]7
EthylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BURSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.]7
HypromellosesINACTIVE INGREDIENT3NXW29V3WOURSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.]7
Magnesium stearateINACTIVE INGREDIENT70097M6I30URSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.]7
Polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PURSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.]7
Polyethylene glycol 8000INACTIVE INGREDIENTQ662QK8M3BURSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.]7
Povidone K29/32INACTIVE INGREDIENT390RMW2PEQURSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.]7
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2URSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58914-785URSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [ALLERGAN, INC.]18Current NDC, Legacy NDC, 1 package rows20240920_e8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858735Urso Forte 500 MG Oral TabletPSNe8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a6119
858752Urso-250 250 MG Oral TabletPSNe8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a6119
858751ursodiol 250 MG Oral TabletPSNe8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a6119
858733ursodiol 500 MG Oral TabletPSNe8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a6119
858752ursodiol 250 MG Oral Tablet [Urso]SBDe8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a6119
858735ursodiol 500 MG Oral Tablet [Urso Forte]SBDe8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a6119
858751ursodiol 250 MG Oral TabletSCDe8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a6119
858733ursodiol 500 MG Oral TabletSCDe8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a6119
858752Urso 250 MG Oral TabletSYe8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a6119
858735Urso Forte 500 MG Oral TabletSYe8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a6119
858752Urso-250 Oral TabletSYe8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a6119

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58914-785-1058914078510100 TABLET, FILM COATED in 1 BOTTLE (58914-785-10) 1997-12-100000-00-00NoNoCurrent