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, 10 mg (NDC 69516-010-30)
- Package NDC
- 69516-010-30
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
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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, 10 mg (NDC 69516-010-30). 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.
Read our methodology — how this data is sourced, computed, and verified.