Search by Drug Name or NDC

NDC 68462-0473-30 Ursodiol 250 mg/1 Details

Ursodiol 250 mg/1

Ursodiol is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., USA. 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: 68462-0473-30
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ursodiol

Product Information

NDC	68462-0473
Product ID	68462-473_f2c1fcd8-7d64-42c8-bd0b-5579592e127f
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	Generic
Proprietary Name	Ursodiol
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ursodiol
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	250
Active Ingredient Units	mg/1
Substance Name	URSODIOL
Labeler Name	Glenmark Pharmaceuticals Inc., USA
Pharmaceutical Class	Bile Acid [EPC], Bile Acids and Salts [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090801
Listing Certified Through	2024-12-31

Package

NDC 68462-0473-30 (68462047330)

Pricing Information	N/A
NDC Package Code	68462-473-30
Billing NDC	68462047330
Package	30 TABLET in 1 BOTTLE (68462-473-30)
Marketing Start Date	2011-07-12
NDC Exclude Flag	N