ursodiol

Generic: ursodiol

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ursodiol
Generic Name ursodiol
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ursodiol 250 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-473
Product ID 68462-473_71c17751-51cb-411d-b90b-4b98ad4a768e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090801
Listing Expiration 2027-12-31
Marketing Start 2011-07-12

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 68462473
Hyphenated Format 68462-473

Supplemental Identifiers

RxCUI
858733 858751
UPC
0368462474013 0368462473016
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 ANDA090801 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68462-473-01)
  • 500 TABLET in 1 BOTTLE (68462-473-05)
  • 30 TABLET in 1 BOTTLE (68462-473-30)
source: ndc

Packages (3)

68462-473-01 100 TABLET in 1 BOTTLE (68462-473-01) 68462-473-05 500 TABLET in 1 BOTTLE (68462-473-05) 68462-473-30 30 TABLET in 1 BOTTLE (68462-473-30)

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": "71c17751-51cb-411d-b90b-4b98ad4a768e", "openfda": {"nui": ["N0000175802", "M0002475"], "upc": ["0368462474013", "0368462473016"], "unii": ["724L30Y2QR"], "rxcui": ["858733", "858751"], "spl_set_id": ["fb79b62a-b450-4d7a-be28-5ee4d174fd58"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68462-473-01)", "package_ndc": "68462-473-01", "marketing_start_date": "20110712"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68462-473-05)", "package_ndc": "68462-473-05", "marketing_start_date": "20110712"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68462-473-30)", "package_ndc": "68462-473-30", "marketing_start_date": "20110712"}], "brand_name": "Ursodiol", "product_id": "68462-473_71c17751-51cb-411d-b90b-4b98ad4a768e", "dosage_form": "TABLET", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "68462-473", "generic_name": "Ursodiol", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ursodiol", "active_ingredients": [{"name": "URSODIOL", "strength": "250 mg/1"}], "application_number": "ANDA090801", "marketing_category": "ANDA", "marketing_start_date": "20110712", "listing_expiration_date": "20271231"}