Drugplain

HEPCLUDEX 8.5 mg/1

BULEVIRTIDE · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Gilead Sciences, Inc.

No Recall History
Plain English

Hepcludex (bulevirtide) is a prescription injection used to treat chronic hepatitis D infection in adults. It is given as a subcutaneous injection and works by blocking the entry of the hepatitis D virus into liver cells.

Key Facts

Brand Name
HEPCLUDEX
Generic Name
BULEVIRTIDE
NDC Code (Product)
61958-3104
Manufacturer
Gilead Sciences, Inc.
Strength
8.5 mg/1
Dosage Form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
SUBCUTANEOUS
Marketing Status
Application #
BLA761468
Marketing Start
05/22/2026

Recall History

No Recall History

Frequently Asked Questions

What is HEPCLUDEX used for?

Hepcludex (bulevirtide) is a prescription injection used to treat chronic hepatitis D infection in adults. It is given as a subcutaneous injection and works by blocking the entry of the hepatitis D virus into liver cells.

Is HEPCLUDEX a controlled substance?

HEPCLUDEX is not classified as a controlled substance by the DEA.

What is the generic name for HEPCLUDEX?

The generic name for HEPCLUDEX is BULEVIRTIDE. There are no other listed brand versions of BULEVIRTIDE.

What is the NDC code for HEPCLUDEX 8.5 mg/1?

The NDC (National Drug Code) for HEPCLUDEX 8.5 mg/1 is 61958-3104, listed by Gilead Sciences, Inc..

Product NDC

61958-3104

Package NDC

61958-3104-1

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)