ursodiol

Generic: ursodiol

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ursodiol
Generic Name ursodiol
Labeler avkare
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ursodiol 500 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-931
Product ID 42291-931_48c0d20b-d59e-c74b-e063-6394a90a1f3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202540
Listing Expiration 2027-12-31
Marketing Start 2023-12-14

Pharmacologic Class

Established (EPC)
bile acid [epc]
Chemical Structure
bile acids and salts [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291931
Hyphenated Format 42291-931

Supplemental Identifiers

RxCUI
858733
UPC
0342291931015
UNII
724L30Y2QR
NUI
N0000175802 M0002475

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ursodiol (source: ndc)
Generic Name ursodiol (source: ndc)
Application Number ANDA202540 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (42291-931-01)
source: ndc

Packages (1)

42291-931-01 100 TABLET, FILM COATED in 1 BOTTLE (42291-931-01)

Ingredients (1)

ursodiol (500 mg/1)

Linked Drug Pages (1)

Ursodiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48c0d20b-d59e-c74b-e063-6394a90a1f3f", "openfda": {"nui": ["N0000175802", "M0002475"], "upc": ["0342291931015"], "unii": ["724L30Y2QR"], "rxcui": ["858733"], "spl_set_id": ["0c7e1aa2-704c-435d-e063-6394a90a2d08"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (42291-931-01)", "package_ndc": "42291-931-01", "marketing_start_date": "20231214"}], "brand_name": "Ursodiol", "product_id": "42291-931_48c0d20b-d59e-c74b-e063-6394a90a1f3f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "42291-931", "generic_name": "Ursodiol", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ursodiol", "active_ingredients": [{"name": "URSODIOL", "strength": "500 mg/1"}], "application_number": "ANDA202540", "marketing_category": "ANDA", "marketing_start_date": "20231214", "listing_expiration_date": "20271231"}