ursodiol

Generic: ursodiol

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ursodiol
Generic Name ursodiol
Labeler amneal pharmaceuticals ny llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

ursodiol 300 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1540
Product ID 69238-1540_5669f4be-fc2b-4231-b9d2-30159562b284
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211301
Listing Expiration 2026-12-31
Marketing Start 2018-10-22

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 692381540
Hyphenated Format 69238-1540

Supplemental Identifiers

RxCUI
858747
UPC
0369238154016
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 ANDA211301 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (69238-1540-1)
source: ndc

Packages (1)

69238-1540-1 100 CAPSULE in 1 BOTTLE (69238-1540-1)

Ingredients (1)

ursodiol (300 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": "5669f4be-fc2b-4231-b9d2-30159562b284", "openfda": {"nui": ["N0000175802", "M0002475"], "upc": ["0369238154016"], "unii": ["724L30Y2QR"], "rxcui": ["858747"], "spl_set_id": ["1027b933-f64f-4a43-996f-a676b5f72da0"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (69238-1540-1)", "package_ndc": "69238-1540-1", "marketing_start_date": "20181022"}], "brand_name": "Ursodiol", "product_id": "69238-1540_5669f4be-fc2b-4231-b9d2-30159562b284", "dosage_form": "CAPSULE", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "69238-1540", "generic_name": "Ursodiol", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ursodiol", "active_ingredients": [{"name": "URSODIOL", "strength": "300 mg/1"}], "application_number": "ANDA211301", "marketing_category": "ANDA", "marketing_start_date": "20181022", "listing_expiration_date": "20261231"}