FDA.reportPublic FDA data

NDC 61958-3104-2 - HEPCLUDEX

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
61958-3104
Requested NDC
61958-3104-2
Package NDCs from labels
61958-3104-2, 61958-3104-1
Manufacturer
Gilead Sciences, Inc.
Effective date
2026-05-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HEPCLUDEX - Gilead Sciences, Inc.Gilead Sciences, Inc.2026-05-22HUMAN PRESCRIPTION DRUG LABEL

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

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 2 of 21 · 402 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
NitrogenNITROGENMaine Oxy-Acetylene Supply Company652ecc66-c6bb-40a3-a12f-64c7a4cdaca82026-06-18Exact identifier
unii: N762921K75
NitrogenNITROGENArcet Equipment Company dba Arc3 Gases Northff2ba9fb-e58a-4e57-8e96-b7e90cc6e2a82026-06-18Exact identifier
unii: N762921K75
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NITROGEN Compressed, NFNITROGENAIRGAS USA, LLC6638a09f-7d87-48ce-934b-5edb3891ad612026-06-15Exact identifier
unii: N762921K75
Nitrogen, RefrigeratedNITROGEN, REFRIGERATEDAirgas Usa, LLC9c536407-8936-4a32-91c2-22712ae2c1f22026-06-15Exact identifier
unii: N762921K75
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
NitrogenNITROGENTerry Supply Company Inc52e5a40a-e974-929e-e063-6294a90aa5772026-05-28Exact identifier
unii: N762921K75
HEPCLUDEXBULEVIRTIDEGilead Sciences, Inc.12391cc2-38c2-4cf5-86d3-2be9370127fc2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761468
ndc (package): 61958-3104-2
ndc (package): 61958-3104-1
ndc (product): 61958-3104
ndc11 (package): 61958310402
rxcui: 2743617
rxcui: 2743611
spl id: 11157b93-ad66-4935-8d4a-b0829c809187
spl set id: 12391cc2-38c2-4cf5-86d3-2be9370127fc
unii: LLM855Y3S3
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NitrogenNITROGENNexAir, LLC4da119c6-59e9-4f95-9c0c-483b5e2162fb2026-05-21Exact identifier
unii: N762921K75
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
NitrogenNITROGENUCG Georgia, LLC7b077025-c8f6-2790-e053-2991aa0aa9c22026-05-11Exact identifier
unii: N762921K75
PlenamineLYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINEB. Braun Medical Inc.a3244d1a-45b0-4e4c-bd96-f0632d761a1f2026-05-08Warnings, Adverse reactionsExact identifier
unii: 4QD397987E

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.