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NDC 42291-0931-01 Ursodiol 500 mg/1 Details
Ursodiol 500 mg/1
Ursodiol is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. 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 cholangitis (PBC; formerly known as a primary biliary cirrhosis; an autoimmune liver disease). Ursodiol is in a class of medications called gallstone dissolution agents. 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: 42291-0931-01Last Updated: 04/07/2024
MedLinePlus Full Drug Details: Ursodiol
Product Information
| NDC | 42291-0931 |
|---|---|
| Product ID | 42291-931_0c7e1aad-cc5e-ecd3-e063-6294a90ab9f9 |
| Associated GPIs | |
| GCN Sequence Number | 050628 |
| GCN Sequence Number Description | ursodiol TABLET 500 MG ORAL |
| HIC3 | D7A |
| HIC3 Description | BILE SALTS |
| GCN | 17730 |
| 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, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | URSODIOL |
| Labeler Name | AvKARE |
| Pharmaceutical Class | Bile Acid [EPC], Bile Acids and Salts [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA202540 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42291-0931-01 (42291093101)
| NDC Package Code | 42291-931-01 |
|---|---|
| Billing NDC | 42291093101 |
| Package | 100 TABLET, FILM COATED in 1 BOTTLE (42291-931-01) |
| Marketing Start Date | 2023-12-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |