ursodiol

Generic: ursodiol

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name ursodiol
Generic Name ursodiol
Labeler avkare
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

ursodiol 300 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-923
Product ID 42291-923_48bfa576-f7b2-85ff-e063-6394a90a0504
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA019594
Listing Expiration 2027-12-31
Marketing Start 2023-07-18

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 42291923
Hyphenated Format 42291-923

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 NDA019594 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (42291-923-01)
source: ndc

Packages (1)

42291-923-01 100 CAPSULE in 1 BOTTLE (42291-923-01)

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": "48bfa576-f7b2-85ff-e063-6394a90a0504", "openfda": {"nui": ["N0000175802", "M0002475"], "unii": ["724L30Y2QR"], "rxcui": ["858747"], "spl_set_id": ["00c47258-aef0-53f6-e063-6294a90af96f"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (42291-923-01)", "package_ndc": "42291-923-01", "marketing_start_date": "20230718"}], "brand_name": "Ursodiol", "product_id": "42291-923_48bfa576-f7b2-85ff-e063-6394a90a0504", "dosage_form": "CAPSULE", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "42291-923", "generic_name": "Ursodiol", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ursodiol", "active_ingredients": [{"name": "URSODIOL", "strength": "300 mg/1"}], "application_number": "NDA019594", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20230718", "listing_expiration_date": "20271231"}