urso 250

Generic: ursodiol

Labeler: allergan, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name urso 250
Generic Name ursodiol
Labeler allergan, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ursodiol 250 mg/1

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 58914-785
Product ID 58914-785_06904c03-cea9-4532-8e27-7f2246be613b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020675
Listing Expiration 2026-12-31
Marketing Start 1997-12-10

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 58914785
Hyphenated Format 58914-785

Supplemental Identifiers

RxCUI
858733 858735 858751 858752
UNII
724L30Y2QR
NUI
N0000175802 M0002475

Packaging Origin

Original Packager
true

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 urso 250 (source: ndc)
Generic Name ursodiol (source: ndc)
Application Number NDA020675 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (58914-785-10)
source: ndc

Packages (1)

58914-785-10 100 TABLET, FILM COATED in 1 BOTTLE (58914-785-10)

Ingredients (1)

ursodiol (250 mg/1)

Linked Drug Pages (1)

Urso 250, Urso Forte ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "06904c03-cea9-4532-8e27-7f2246be613b", "openfda": {"nui": ["N0000175802", "M0002475"], "unii": ["724L30Y2QR"], "rxcui": ["858733", "858735", "858751", "858752"], "spl_set_id": ["e8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a61"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (58914-785-10)", "package_ndc": "58914-785-10", "marketing_start_date": "19971210"}], "brand_name": "Urso 250", "product_id": "58914-785_06904c03-cea9-4532-8e27-7f2246be613b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "58914-785", "generic_name": "Ursodiol", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Urso 250", "active_ingredients": [{"name": "URSODIOL", "strength": "250 mg/1"}], "application_number": "NDA020675", "marketing_category": "NDA", "marketing_start_date": "19971210", "listing_expiration_date": "20261231"}