ursodiol

Generic: ursodiol

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ursodiol 250 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6890
Product ID 0904-6890_ca0b53eb-7518-475a-9b3e-0dec31111904
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202540
Listing Expiration 2026-12-31
Marketing Start 2013-08-01

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 09046890
Hyphenated Format 0904-6890

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
  • 30 BLISTER PACK in 1 CARTON (0904-6890-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6890-04 30 BLISTER PACK in 1 CARTON (0904-6890-04) / 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": "ca0b53eb-7518-475a-9b3e-0dec31111904", "openfda": {"nui": ["N0000175802", "M0002475"], "unii": ["724L30Y2QR"], "rxcui": ["858751"], "spl_set_id": ["e1f6abfd-2158-4824-b53d-717fbe6de3f9"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-6890-04)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6890-04", "marketing_start_date": "20130801"}], "brand_name": "Ursodiol", "product_id": "0904-6890_ca0b53eb-7518-475a-9b3e-0dec31111904", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "0904-6890", "generic_name": "Ursodiol", "labeler_name": "Major Pharmaceuticals", "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": "20130801", "listing_expiration_date": "20261231"}