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NDC 43063-0871-01 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 PD-Rx Pharmaceuticals, Inc.. The primary component is URSADIOL.

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: 43063-0871-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ursodiol

Product Information

NDC	43063-0871
Product ID	43063-871_065c25f6-54b6-2127-e063-6394a90a6df7
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	Ursosiol
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	300
Active Ingredient Units	mg/1
Substance Name	URSADIOL
Labeler Name	PD-Rx Pharmaceuticals, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA210707
Listing Certified Through	2024-12-31

Package

NDC 43063-0871-01 (43063087101)

Pricing Information	N/A
NDC Package Code	43063-871-01
Billing NDC	43063087101
Package	100 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-01)
Marketing Start Date	2018-07-26
NDC Exclude Flag	N