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Ursodiol 400 mg

Ursodiol · Capsule

Prescription ANDA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Ursodiol 400 mg
Generic name
Ursodiol
Dosage form
Capsule
Route
Oral
Marketing category
ANDA · ANDA
Labeler
FH2 Pharma LLC
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Ursodiol 400 mg/1 858747 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule
Route of administration
Oral
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Bile Acid [EPC] EPC 6 members — no class page
Bile Acids and Salts [CS] CS 6 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
205789
Application type
ANDA · Abbreviated New Drug Application
Approval date
May 8, 2020
Sponsor
LGM PHARMA
Products on application
2
Submissions recorded
1
Products approved under application 205789.
Product Trade name Form Strength Ingredient Status TE Flags
205789-001 URSODIOL CAPSULE URSODIOL Prescription —
205789-002 URSODIOL CAPSULE URSODIOL Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 205789.
Type No. Action Status Date Review
Original application 1 Approved May 8, 2020 Standard

Review documents

  • 0 · Original application · June 4, 2020

Adverse event reports

Source: openFDA FAERS
21,652
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: URSODIOL. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
72887-144-06 72887-144 FH2 Pharma LLC 60 CAPSULE in 1 BOTTLE (72887-144-06) November 18, 2021
79739-7144-1 79739-7144 LGM PHARMA SOLUTIONS, LLC 100 CAPSULE in 1 BOTTLE (79739-7144-1) July 1, 2020
72887-144 72887-144 FH2 Pharma LLC — November 18, 2021
79739-7144 79739-7144 LGM PHARMA SOLUTIONS, LLC — July 1, 2020

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 9 sections on this page.