ursodiol

Generic: ursodiol

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ursodiol
Generic Name ursodiol
Labeler bluepoint laboratories
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ursodiol 250 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-377
Product ID 68001-377_faf3de2a-e9da-091a-e053-6394a90ae498
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090801
Listing Expiration 2026-12-31
Marketing Start 2019-02-26

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 68001377
Hyphenated Format 68001-377

Supplemental Identifiers

RxCUI
858733 858751
UPC
0368001378000 0368001377003
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 (68001-377-00)
source: ndc

Packages (1)

68001-377-00 100 TABLET in 1 BOTTLE (68001-377-00)

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": "faf3de2a-e9da-091a-e053-6394a90ae498", "openfda": {"nui": ["N0000175802", "M0002475"], "upc": ["0368001378000", "0368001377003"], "unii": ["724L30Y2QR"], "rxcui": ["858733", "858751"], "spl_set_id": ["a3c98080-0a4d-4a93-8dcb-02ab8533050b"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68001-377-00)", "package_ndc": "68001-377-00", "marketing_start_date": "20190226"}], "brand_name": "Ursodiol", "product_id": "68001-377_faf3de2a-e9da-091a-e053-6394a90ae498", "dosage_form": "TABLET", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "68001-377", "generic_name": "Ursodiol", "labeler_name": "BluePoint Laboratories", "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": "20190226", "listing_expiration_date": "20261231"}