FDA.reportPublic FDA data

HEPCLUDEX

Product NDC
61958-3104
11-digit product format
619583104
Labeler code
61958
Product ID
61958-3104_11157b93-ad66-4935-8d4a-b0829c809187
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BULEVIRTIDE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
SUBCUTANEOUS
Labeler
Gilead Sciences, Inc.
Application
BLA761468
Marketing category
BLA
Marketing start
2026-05-22
Substance
BULEVIRTIDE ACETATE
Active strength
8.5 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEPCLUDEXBULEVIRTIDEGilead Sciences, Inc.12391cc2-38c2-4cf5-86d3-2be9370127fc2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761468
ndc (product): 61958-3104

Additional Listing Data#

Finished product
Yes
Brand name base
HEPCLUDEX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BULEVIRTIDE ACETATE8.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LLM855Y3S3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2743611Internal RxNorm lookup
2743617Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
12391cc2-38c2-4cf5-86d3-2be9370127fcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-3104-1HEPCLUDEX30 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,301
61958-3104-2HEPCLUDEX1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,11

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761468Hepcludexbulevirtide-gmod351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2743611bulevirtide-gmod 8.5 MG InjectionPSN12391cc2-38c2-4cf5-86d3-2be9370127fc1
2743617HEPCLUDEX 8.5 MG InjectionPSN12391cc2-38c2-4cf5-86d3-2be9370127fc1
2743617bulevirtide-gmod 8.5 MG Injection [Hepcludex]SBD12391cc2-38c2-4cf5-86d3-2be9370127fc1
2743611bulevirtide-gmod 8.5 MG InjectionSCD12391cc2-38c2-4cf5-86d3-2be9370127fc1
2743617Hepcludex 8.5 MG InjectionSY12391cc2-38c2-4cf5-86d3-2be9370127fc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
61958-3104-16195831040130 VIAL, SINGLE-DOSE in 1 CARTON (61958-3104-1) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (61958-3104-2) 2026-05-22NoNoCurrent
61958-3104-2619583104021 in 1 VIAL, SINGLE-DOSEHistorical