ursodiol 400 mg

Generic: ursodiol

Labeler: fh2 pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ursodiol 400 mg
Generic Name ursodiol
Labeler fh2 pharma llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

ursodiol 400 mg/1

Manufacturer
FH2 Pharma LLC

Identifiers & Regulatory

Product NDC 72887-144
Product ID 72887-144_c28d41e2-14c2-4401-87ab-49b32239caba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205789
Listing Expiration 2026-12-31
Marketing Start 2021-11-18

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 72887144
Hyphenated Format 72887-144

Supplemental Identifiers

RxCUI
412174 2376942
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 400 mg (source: ndc)
Generic Name ursodiol (source: ndc)
Application Number ANDA205789 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (72887-144-06)
source: ndc

Packages (1)

72887-144-06 60 CAPSULE in 1 BOTTLE (72887-144-06)

Ingredients (1)

ursodiol (400 mg/1)

Linked Drug Pages (1)

Ursodiol 200 mg, Ursodiol 400 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c28d41e2-14c2-4401-87ab-49b32239caba", "openfda": {"nui": ["N0000175802", "M0002475"], "unii": ["724L30Y2QR"], "rxcui": ["412174", "2376942"], "spl_set_id": ["476179dc-b410-4305-881b-470511765647"], "pharm_class_cs": ["Bile Acids and Salts [CS]"], "pharm_class_epc": ["Bile Acid [EPC]"], "manufacturer_name": ["FH2 Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (72887-144-06)", "package_ndc": "72887-144-06", "marketing_start_date": "20211118"}], "brand_name": "Ursodiol 400 mg", "product_id": "72887-144_c28d41e2-14c2-4401-87ab-49b32239caba", "dosage_form": "CAPSULE", "pharm_class": ["Bile Acid [EPC]", "Bile Acids and Salts [CS]"], "product_ndc": "72887-144", "generic_name": "Ursodiol", "labeler_name": "FH2 Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ursodiol 400 mg", "active_ingredients": [{"name": "URSODIOL", "strength": "400 mg/1"}], "application_number": "ANDA205789", "marketing_category": "ANDA", "marketing_start_date": "20211118", "listing_expiration_date": "20261231"}