ursodiol

Generic: ursodiol

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ursodiol
Generic Name ursodiol
Labeler cardinal health 107, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ursodiol 250 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-2633
Product ID 55154-2633_cc868448-2155-45e6-a13b-72bc0d0f0fc8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202540
Listing Expiration 2026-12-31
Marketing Start 2024-10-31

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 551542633
Hyphenated Format 55154-2633

Supplemental Identifiers

RxCUI
858751
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
  • 250 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-2633-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

55154-2633-0 10 BLISTER PACK in 1 BAG (55154-2633-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

ursodiol (250 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": "cc868448-2155-45e6-a13b-72bc0d0f0fc8", "openfda": {"nui": ["N0000175802", "M0002475"], "unii": ["724L30Y2QR"], "rxcui": ["858751"], "spl_set_id": ["61dcaec8-3acb-4ef0-afde-65a66e99afa7"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-2633-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55154-2633-0", "marketing_start_date": "20241031"}], "brand_name": "Ursodiol", "product_id": "55154-2633_cc868448-2155-45e6-a13b-72bc0d0f0fc8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "55154-2633", "generic_name": "Ursodiol", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ursodiol", "active_ingredients": [{"name": "URSODIOL", "strength": "250 mg/1"}], "application_number": "ANDA202540", "marketing_category": "ANDA", "marketing_start_date": "20241031", "listing_expiration_date": "20261231"}