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NDC 72887-0144-06 Ursodiol 400 mg 400 mg/1 Details

Ursodiol 400 mg 400 mg/1

Ursodiol 400 mg is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by FH2 Pharma LLC. 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: 72887-0144-06
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ursodiol

Product Information

NDC	72887-0144
Product ID	72887-144_c28d41e2-14c2-4401-87ab-49b32239caba
Associated GPIs	52100040000130
GCN Sequence Number	081873
GCN Sequence Number Description	ursodiol CAPSULE 400 MG ORAL
HIC3	D7A
HIC3 Description	BILE SALTS
GCN	49115
HICL Sequence Number	001370
HICL Sequence Number Description	URSODIOL
Brand/Generic	Generic
Proprietary Name	Ursodiol 400 mg
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ursodiol
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	400
Active Ingredient Units	mg/1
Substance Name	URSODIOL
Labeler Name	FH2 Pharma LLC
Pharmaceutical Class	Bile Acid [EPC], Bile Acids and Salts [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA205789
Listing Certified Through	2024-12-31

Package

NDC 72887-0144-06 (72887014406)

Pricing Information	N/A
NDC Package Code	72887-144-06
Billing NDC	72887014406
Package	60 CAPSULE in 1 BOTTLE (72887-144-06)
Marketing Start Date	2021-11-18
NDC Exclude Flag	N