What is Reltone 400 mg?

Reltone 400 mg is a brand name of Ursodiol, a prescription medicine. The FDA NDC Directory lists 1 Reltone 400 mg product in 1 strength and form.

Who makes Reltone 400 mg?

LGM Pharma holds the FDA application for Reltone 400 mg (ANDA205789, approved May 8, 2020).

Is there a generic or store brand of Reltone 400 mg?

Yes. The FDA NDC Directory lists 2 other products with the same active ingredients, strength and form as a Reltone 400 mg product, 2 of them generic. Ask your pharmacist whether one is right for you.

Reltone 400 mg (Ursodiol): maker, FDA approval and generic versions

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Reltone 400 mg?: Reltone 400 mg is a brand name of Ursodiol, a prescription medicine. The FDA NDC Directory lists 1 Reltone 400 mg product in 1 strength and form.
Who makes Reltone 400 mg?: LGM Pharma holds the FDA application for Reltone 400 mg (ANDA205789, approved May 8, 2020).
Is there a generic or store brand of Reltone 400 mg?: Yes. The FDA NDC Directory lists 2 other products with the same active ingredients, strength and form as a Reltone 400 mg product, 2 of them generic. Ask your pharmacist whether one is right for you.
Has Reltone 400 mg been recalled?: No recall linked to Reltone 400 mg products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Reltone 400 mg is

Each Reltone 400 mg product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Ursodiol · prescription medicine

Strength and form	Product names	Same medicine, other names	Label
ursodiol 400 mg capsule (oral)	Reltone 400 mg	2 products, 2 companies	DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Ursodiol →

FDA approval

ANDA: Abbreviated New Drug Application: how a generic version is approved.

FDA applications of Reltone 400 mg products (Drugs@FDA)
Application	Holder	First approved	Products
ANDA205789	LGM Pharma	May 8, 2020	1

Companies that list Reltone 400 mg

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Reltone 400 mg products.

Intra-Sana Laboratories1 product

Recalls

No recall linked to Reltone 400 mg products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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Reltone 400 mg