FDA.reportPublic FDA data

WINREVAIR

Product NDC
0006-5091
11-digit product format
000065091
Labeler code
0006
Product ID
0006-5091_8527c7f5-21e5-4965-8b9b-3fe0880a36f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SOTATERCEPT-CSRK
Dosage form
KIT
Labeler
Merck Sharp & Dohme LLC
Application
BLA761363
Marketing category
BLA
Marketing start
2024-03-26
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 16 · 305 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
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
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
WINREVAIRSOTATERCEPT-CSRKMerck Sharp & Dohme LLC21693ee2-cd23-4137-ac67-066bb3a4a9b72026-06-17Warnings, Adverse reactionsExact identifier
application number: BLA761363
ndc (package): 0006-5091-01
ndc (package): 0006-5080-89
ndc (package): 0006-5088-01
ndc (package): 0006-5068-99
ndc (package): 0006-5069-99
ndc (package): 0006-5079-89
ndc (package): 0006-5087-01
ndc (package): 0006-5090-01
ndc (product): 0006-5090
ndc (product): 0006-5087
ndc (product): 0006-5091
ndc (product): 0006-5088
spl id: 110e81ef-3051-43aa-a3ee-0542f3076cc5
spl set id: 21693ee2-cd23-4137-ac67-066bb3a4a9b7
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
unii: B22547B95K
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
GUNA-CELLACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINCGuna spa90db80ed-c037-4e8f-a7f6-304a65f9fe222026-06-11WarningsExact identifier
unii: 2968PHW8QP
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
GUNA-FLAMACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENKEFALIN - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - TRANSFORMING GROWTH FACTOR BETA-1 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -Guna spa7bda7eb0-8fd5-42d9-b336-39920bfc964d2026-06-10WarningsExact identifier
unii: 2968PHW8QP

Additional Listing Data#

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
21693ee2-cd23-4137-ac67-066bb3a4a9b7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efefd1cb-59f3-4fb7-8d07-82504ac8e9c7Product name120250128

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-5069-99WINREVAIR1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1 mL60 mg in 1mL8
0006-5080-89WINREVAIR1.3 mL in 1 SYRINGEINJECTION, SOLUTION1.3 mL1.3 mL in 1.3mL8
0006-5091-01WINREVAIR1 in 1 CARTONKIT18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-5091-01EA - Each0006-509146b6163f-1de2-4573-aa9e-3c9c949ee48512024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-5091WINREVAIR (SOTATERCEPT-CSRK) KIT [MERCK SHARP & DOHME LLC]4Current NDC, 3 package rows20250507_21693ee2-cd23-4137-ac67-066bb3a4a9b7.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761363Winrevairsotatercept-csrk351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2678949{2 (sotatercept-csrk 45 MG Injection [Winrevair]) } Pack [Winrevair 45 MG, 2 Vial Kit]BPCK21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678951{2 (sotatercept-csrk 60 MG Injection [Winrevair]) } Pack [Winrevair 60 MG, 2 Vial Kit]BPCK21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678948{2 (sotatercept-csrk 45 MG Injection) } PackGPCK21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678950{2 (sotatercept-csrk 60 MG Injection) } PackGPCK21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678937sotatercept-csrk 45 MG InjectionPSN21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678948sotatercept-csrk 45 MG, 2 Vial KitPSN21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678945sotatercept-csrk 60 MG InjectionPSN21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678950sotatercept-csrk 60 MG, 2 Vial KitPSN21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678943WINREVAIR 45 MG InjectionPSN21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678949Winrevair 45 MG, 2 Vial KitPSN21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678947WINREVAIR 60 MG InjectionPSN21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678951Winrevair 60 MG, 2 Vial KitPSN21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678943sotatercept-csrk 45 MG Injection [Winrevair]SBD21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678947sotatercept-csrk 60 MG Injection [Winrevair]SBD21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678937sotatercept-csrk 45 MG InjectionSCD21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678945sotatercept-csrk 60 MG InjectionSCD21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678948sotatercept-csrk 45 MG, 2 Vial KitSY21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678950sotatercept-csrk 60 MG, 2 Vial KitSY21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678943Winrevair 45 MG InjectionSY21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678949Winrevair 45 MG, 2 Vial KitSY21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678947Winrevair 60 MG InjectionSY21693ee2-cd23-4137-ac67-066bb3a4a9b78
2678951Winrevair 60 MG, 2 Vial KitSY21693ee2-cd23-4137-ac67-066bb3a4a9b78

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0006-5069-99000065069991 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
0006-5080-89000065080891.3 mL in 1 SYRINGE1.3 mlHistorical
0006-5091-01000065091011 KIT in 1 CARTON (0006-5091-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0006-5069-99) * 1.3 mL in 1 SYRINGE (0006-5080-89) 1 kit2024-03-26NoNoCurrent