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NDC 64980-0483-01 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 Rising Pharma Holdings, Inc.. 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: 64980-0483-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ursodiol

Product Information

NDC	64980-0483
Product ID	64980-483_49b564cd-6948-4df1-a7d6-0ce87f8a0a61
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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	Rising Pharma Holdings, Inc.
Pharmaceutical Class	Bile Acid [EPC], Bile Acids and Salts [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA213200
Listing Certified Through	2024-12-31

Package

NDC 64980-0483-01 (64980048301)

Pricing Information	N/A
NDC Package Code	64980-483-01
Billing NDC	64980048301
Package	100 CAPSULE in 1 BOTTLE (64980-483-01)
Marketing Start Date	2020-02-12
NDC Exclude Flag	N