ursodiol

Generic: ursodiol

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ursodiol
Generic Name ursodiol
Labeler bryant ranch prepack
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

ursodiol 300 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-1173
Product ID 63629-1173_c663fa8c-ef49-4375-a30c-1a546735ac77
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212452
Listing Expiration 2026-12-31
Marketing Start 2020-02-05

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 636291173
Hyphenated Format 63629-1173

Supplemental Identifiers

RxCUI
858747
UNII
724L30Y2QR
NUI
N0000175802 M0002475

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 ANDA212452 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (63629-1173-1)
source: ndc

Packages (1)

63629-1173-1 100 CAPSULE in 1 BOTTLE (63629-1173-1)

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": "c663fa8c-ef49-4375-a30c-1a546735ac77", "openfda": {"nui": ["N0000175802", "M0002475"], "unii": ["724L30Y2QR"], "rxcui": ["858747"], "spl_set_id": ["0198041e-9ecd-4f80-8950-39bccaeea155"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (63629-1173-1)", "package_ndc": "63629-1173-1", "marketing_start_date": "20200914"}], "brand_name": "Ursodiol", "product_id": "63629-1173_c663fa8c-ef49-4375-a30c-1a546735ac77", "dosage_form": "CAPSULE", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "63629-1173", "generic_name": "Ursodiol", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ursodiol", "active_ingredients": [{"name": "URSODIOL", "strength": "300 mg/1"}], "application_number": "ANDA212452", "marketing_category": "ANDA", "marketing_start_date": "20200205", "listing_expiration_date": "20261231"}