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NDC 58914-0785-10 Urso 250 250 mg/1 Details

Urso 250 250 mg/1

Urso 250 is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Allergan, Inc.. The primary component is URSODIOL.

MedlinePlus Drug Summary

Ursodiol is used to dissolve gallstones in people who do not want surgery or cannot have surgery to remove gallstones. Ursodiol is also used to prevent the formation of gallstones in overweight people who are losing weight very quickly. Ursodiol is used to treat people with primary biliary cirrhosis (PBC; an autoimmune liver disease). Ursodiol is in a class of medications called gallstone dissolution agentss. It works by decreasing the production of cholesterol and by dissolving the cholesterol in bile to prevent stone formation and by decreasing toxic levels of bile acids that accumulate in primary biliary cirrhosis.

Related Packages: 58914-0785-10
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ursodiol

Product Information

NDC	58914-0785
Product ID	58914-785_43c4e4e7-970e-4d46-9a5a-e832e3846d26
Associated GPIs	52100040000325
GCN Sequence Number	024333
GCN Sequence Number Description	ursodiol TABLET 250 MG ORAL
HIC3	D7A
HIC3 Description	BILE SALTS
GCN	01072
HICL Sequence Number	001370
HICL Sequence Number Description	URSODIOL
Brand/Generic	Brand
Proprietary Name	Urso 250
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ursodiol
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	250
Active Ingredient Units	mg/1
Substance Name	URSODIOL
Labeler Name	Allergan, Inc.
Pharmaceutical Class	Bile Acid [EPC], Bile Acids and Salts [CS]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA020675
Listing Certified Through	2024-12-31

Package

NDC 58914-0785-10 (58914078510)

Pricing Information	N/A
NDC Package Code	58914-785-10
Billing NDC	58914078510
Package	100 TABLET, FILM COATED in 1 BOTTLE (58914-785-10)
Marketing Start Date	1997-12-10
NDC Exclude Flag	N