ursodiol

Generic: ursodiol

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ursodiol
Generic Name ursodiol
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ursodiol 250 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 70710-1127
Product ID 70710-1127_a9c504cd-4b4b-4de5-af5a-70117f04e4ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211145
Listing Expiration 2026-12-31
Marketing Start 2018-11-07

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 707101127
Hyphenated Format 70710-1127

Supplemental Identifiers

RxCUI
858733 858751
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 ANDA211145 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70710-1127-1)
  • 500 TABLET in 1 BOTTLE (70710-1127-5)
source: ndc

Packages (2)

70710-1127-1 100 TABLET in 1 BOTTLE (70710-1127-1) 70710-1127-5 500 TABLET in 1 BOTTLE (70710-1127-5)

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": "a9c504cd-4b4b-4de5-af5a-70117f04e4ea", "openfda": {"nui": ["N0000175802", "M0002475"], "unii": ["724L30Y2QR"], "rxcui": ["858733", "858751"], "spl_set_id": ["55c1556b-8b47-479a-979b-fd61bdd27c7f"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70710-1127-1)", "package_ndc": "70710-1127-1", "marketing_start_date": "20181107"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70710-1127-5)", "package_ndc": "70710-1127-5", "marketing_start_date": "20181107"}], "brand_name": "Ursodiol", "product_id": "70710-1127_a9c504cd-4b4b-4de5-af5a-70117f04e4ea", "dosage_form": "TABLET", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "70710-1127", "generic_name": "Ursodiol", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ursodiol", "active_ingredients": [{"name": "URSODIOL", "strength": "250 mg/1"}], "application_number": "ANDA211145", "marketing_category": "ANDA", "marketing_start_date": "20181107", "listing_expiration_date": "20261231"}