ursodiol

Generic: ursodiol

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name ursodiol
Generic Name ursodiol
Labeler actavis pharma, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ursodiol 250 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-2998
Product ID 0591-2998_3ca902a9-d8c3-4c4b-a49f-efc62cf2028a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020675
Marketing Start 1997-12-10
Marketing End 2026-05-31

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 05912998
Hyphenated Format 0591-2998

Supplemental Identifiers

RxCUI
858733 858751
UPC
0305913005013
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 ursodiol (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 in 1 BOTTLE (0591-2998-01)
source: ndc

Packages (1)

0591-2998-01 100 TABLET in 1 BOTTLE (0591-2998-01)

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": "3ca902a9-d8c3-4c4b-a49f-efc62cf2028a", "openfda": {"nui": ["N0000175802", "M0002475"], "upc": ["0305913005013"], "unii": ["724L30Y2QR"], "rxcui": ["858733", "858751"], "spl_set_id": ["0a7c1ae6-4878-43e7-9026-073f74af64c0"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0591-2998-01)", "package_ndc": "0591-2998-01", "marketing_end_date": "20260531", "marketing_start_date": "19971210"}], "brand_name": "Ursodiol", "product_id": "0591-2998_3ca902a9-d8c3-4c4b-a49f-efc62cf2028a", "dosage_form": "TABLET", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "0591-2998", "generic_name": "Ursodiol", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ursodiol", "active_ingredients": [{"name": "URSODIOL", "strength": "250 mg/1"}], "application_number": "NDA020675", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20260531", "marketing_start_date": "19971210"}