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To Be Discontinued Tablet Gastroenterology

Obeticholic Acid Tablet

This drug is currently listed as to be discontinued by the FDA. Affected manufacturer: Intercept Pharmaceuticals.

Active FDA Drug Shortage

Contact your pharmacist if you are affected. They can check availability from other manufacturers or suggest alternatives.

Shortage Details

Generic Name
Obeticholic Acid Tablet
Manufacturer
Intercept Pharmaceuticals
Dosage Form
Tablet
Presentation
Ocaliva, Tablet, 5 mg (NDC 69516-005-30)
Package NDC
69516-005-30

Status & Timeline

Status
To Be Discontinued
First Reported
Sep 19, 2025
Last Updated
Sep 19, 2025
Therapeutic Category
Gastroenterology

Shortage Reason

Business decision. Products will not be available after November 14, 2025.

Nearby — Other Obeticholic Shortage Records

Frequently Asked Questions

Why is Obeticholic in shortage?
According to FDA data: Business decision. Products will not be available after November 14, 2025.
What can I do if my medication is in shortage?
Contact your pharmacist — they can check availability across suppliers or suggest an equivalent from a different manufacturer. Your prescriber may also recommend a therapeutic substitute from the same drug class.
How often is this data updated?
Shortage data comes from the FDA Drug Shortages Database via openFDA. The database is updated regularly as manufacturers report changes to the FDA.

What This Obeticholic Shortage Record Means

The FDA Drug Shortages database lists this record for Obeticholic Acid Tablet from Intercept Pharmaceuticals with a current status of To Be Discontinued. The affected dosage form is Tablet, presented as Ocaliva, Tablet, 5 mg (NDC 69516-005-30). Shortages are tracked at the manufacturer and presentation level — other manufacturers or formulations of the same generic may remain available, which is why pharmacists often can source a working substitute even when one record is flagged.

This shortage was first reported on Sep 19, 2025 and was last updated Sep 19, 2025. The FDA cites the following reason: Business decision. There is 1 other current record in this database covering the same generic, which gives a fuller picture of how disruption is playing out across manufacturers and dosage forms.

A shortage listing is a supply-side signal, not a patient-level instruction. Access can vary dramatically by pharmacy, region, hospital system, and insurance formulary — local pharmacists have real-time visibility that a national database cannot provide. Therapeutic substitutes often exist in the same class, but switching decisions belong with your prescriber, who weighs efficacy, dosing conversion, interaction profile, and personal history. This page summarizes public FDA data for educational reference only and is not medical advice. If your medication is affected, contact your pharmacist and prescriber to plan an appropriate response.

Disclaimer: This information comes from the FDA Drug Shortages Database and is for educational purposes only. It is not medical advice. Do not stop or change any medication without consulting your healthcare provider or pharmacist. Shortage status can change rapidly — always verify current availability with your pharmacist.