FDA.reportPublic FDA data

NDC 0006-5080 - WINREVAIR

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
0006-5080
Package NDCs from labels
0006-5080-89
Manufacturer
Merck Sharp & Dohme LLC
Effective date
2026-09-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
WINREVAIR - Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC2026-09-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-5080-89WINREVAIR1.3 mL in 1 SYRINGEINJECTION, SOLUTION2.6 mL1.3 mL in 1.3mL8
0006-5080-89WINREVAIR1.3 mL in 1 SYRINGEINJECTION, SOLUTION1.3 mL1.3 mL in 1.3mL8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-5080WINREVAIR (SOTATERCEPT-CSRK) KIT [MERCK SHARP & DOHME LLC]4Unmatched20250507_21693ee2-cd23-4137-ac67-066bb3a4a9b7.zip

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 3 of 16 · 305 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticoagulant Sodium CitrateTRISODIUM CITRATE DIHYDRATELABORATORIOS GRIFOLS SAdb8334be-5b8b-4811-811a-efbe32b6d1472026-04-14WarningsExact identifier
unii: B22547B95K
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.4a8be3aa-9bd9-4bb1-af98-a940c13b2bd02026-04-10WarningsExact identifier
unii: C151H8M554
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.214eb19a-e7a2-421c-9f34-724ce430185c2026-04-10WarningsExact identifier
unii: C151H8M554
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
unii: 2968PHW8QP
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Drop20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Pick Enterprises Corpbaa96813-dc95-472e-a834-880a0cd484a72026-03-13WarningsExact identifier
unii: C151H8M554
Appetrol 20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Carbalor LLCd66234a3-2477-42be-8f7b-283e3a5f87ed2026-03-12WarningsExact identifier
unii: C151H8M554
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
TricitratesTRICITRATESChartwell Governmental & Specialty RX, LLC.c4ff0407-3930-4c48-afd4-d2cb3e1b18f42026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC.fd57a176-7faf-4053-b348-6ba5f192f05a2026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
unii: B22547B95K
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SWISS BLEU Relief-Calm Antimicrobial Skin CreamLACTOBACILLUS FERMENT LYSATE, LEONTOPODIUM ALPINUM, CALENDULA OFFICINALIS FLOWER EXTRACT, EVENING PRIMROSE FLOWER EXTRACT, CITRIC ACIDNanjing Hongruixing Biological Technology Co., Ltd487d3c2c-ce28-f7a1-e063-6294a90a5ec62026-01-16WarningsExact identifier
unii: 2968PHW8QP
WALGREENS UPSET STOMACH and NAUSEA RELIEFSODIUM CITRATE DIHYDRATEWALGREENS CO.2de7ff66-af75-4d9d-b493-29b37dadc5d82026-01-15WarningsExact identifier
unii: B22547B95K
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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