ursodiol

Generic: ursodiol

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ursodiol 300 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-797
Product ID 50268-797_48378beb-66aa-975e-e063-6294a90a0aee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211301
Listing Expiration 2027-12-31
Marketing Start 2021-02-19

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 50268797
Hyphenated Format 50268-797

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 ANDA211301 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-797-15) / 1 CAPSULE in 1 BLISTER PACK (50268-797-11)
source: ndc

Packages (1)

50268-797-15 50 BLISTER PACK in 1 BOX (50268-797-15) / 1 CAPSULE in 1 BLISTER PACK (50268-797-11)

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": "48378beb-66aa-975e-e063-6294a90a0aee", "openfda": {"nui": ["N0000175802", "M0002475"], "unii": ["724L30Y2QR"], "rxcui": ["858747"], "spl_set_id": ["bbb1f297-1536-9550-e053-2995a90a0d41"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-797-15)  / 1 CAPSULE in 1 BLISTER PACK (50268-797-11)", "package_ndc": "50268-797-15", "marketing_start_date": "20210219"}], "brand_name": "Ursodiol", "product_id": "50268-797_48378beb-66aa-975e-e063-6294a90a0aee", "dosage_form": "CAPSULE", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "50268-797", "generic_name": "Ursodiol", "labeler_name": "AvPAK", "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": "20210219", "listing_expiration_date": "20271231"}