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NDC 63629-1048-01 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 Bryant Ranch Prepack. 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: 63629-1048-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ursodiol

Product Information

NDC	63629-1048
Product ID	63629-1048_fbfb4a5e-fbe0-947a-e053-6294a90a1606
Associated GPIs	52100040000120
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	Bryant Ranch Prepack
Pharmaceutical Class	Bile Acid [EPC], Bile Acids and Salts [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA075517
Listing Certified Through	2024-12-31

Package

NDC 63629-1048-01 (63629104801)

Pricing Information	N/A
NDC Package Code	63629-1048-1
Billing NDC	63629104801
Package	100 CAPSULE in 1 BOTTLE (63629-1048-1)
Marketing Start Date	2019-07-01
NDC Exclude Flag	N