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NDC 42291-0923-01 Ursodiol 300 mg/1 Details

Ursodiol 300 mg/1

Ursodiol is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. 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 cholangitis (PBC; formerly known as a primary biliary cirrhosis; an autoimmune liver disease). Ursodiol is in a class of medications called gallstone dissolution agents. 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: 42291-0923-01
Last Updated: 04/07/2024
MedLinePlus Full Drug Details: Ursodiol

Product Information

NDC	42291-0923
Product ID	42291-923_00c45ba8-b94f-f7b0-e063-6394a90affd0
Associated GPIs
GCN Sequence Number	003095
GCN Sequence Number Description	ursodiol CAPSULE 300 MG ORAL
HIC3	D7A
HIC3 Description	BILE SALTS
GCN	01070
HICL Sequence Number	001370
HICL Sequence Number Description	URSODIOL
Brand/Generic	Generic
Proprietary Name	Ursodiol
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ursodiol
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	300
Active Ingredient Units	mg/1
Substance Name	URSODIOL
Labeler Name	AvKARE
Pharmaceutical Class	Bile Acid [EPC], Bile Acids and Salts [CS]
DEA Schedule	n/a
Marketing Category	NDA AUTHORIZED GENERIC
Application Number	NDA019594
Listing Certified Through	2024-12-31

Package

NDC 42291-0923-01 (42291092301)

Pricing Information	N/A
NDC Package Code	42291-923-01
Billing NDC	42291092301
Package	100 CAPSULE in 1 BOTTLE (42291-923-01)
Marketing Start Date	2023-07-18
NDC Exclude Flag	N