Prescription drug · BLA
Hepcludex (bulevirtide) NDC 61958-3104
Bulevirtide acetate 8.5 mg/1 · Injection, Powder, Lyophilized, For solution · Subcutaneous · Gilead Sciences, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61958-3104-1 | 61958310401 | 30 VIAL, SINGLE-DOSE in 1 CARTON (61958-3104-1) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (61958-3104-2)Marketed from May 22, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Hepcludex
- Generic name (nonproprietary)
- bulevirtide
- Active ingredients
- Bulevirtide acetate — 8.5 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Subcutaneous
- Labeler
- Gilead Sciences, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761468
- Marketing start
- Listing expires
- Identifiers
- Product ID 61958-3104_11157b93-ad66-4935-8d4a-b0829c809187SPL ID 11157b93-ad66-4935-8d4a-b0829c809187SPL set ID 12391cc2-38c2-4cf5-86d3-2be9370127fcRxCUI 2743611, 2743617UNII LLM855Y3S3
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N461958310401followed by a unit qualifier and the quantityPackage 61958-3104-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization [see Clinical Studies (14) ] . An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). HEPCLUDEX is a sodium taurocholate co-transporting polypeptide (NTCP)-directed HDV attachment inhibitor indicated for the treatment of chronic HDV infection in adults w…
Excerpt only. Read the full label for complete information.