FDA.reportPublic FDA data

WINREVAIR

Product NDC
0006-5090
11-digit product format
000065090
Labeler code
0006
Product ID
0006-5090_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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WINREVAIRSOTATERCEPT-CSRKMerck Sharp & Dohme LLC21693ee2-cd23-4137-ac67-066bb3a4a9b72026-06-17Warnings, Adverse reactionsExact identifier
application number: BLA761363
ndc (product): 0006-5090

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
0006-5068-99WINREVAIR1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1 mL45 mg in 1mL8
0006-5079-89WINREVAIR1 mL in 1 SYRINGEINJECTION, SOLUTION1 mL1 mL in 1mL8
0006-5090-01WINREVAIR1 in 1 CARTONKIT18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-5090-01EA - Each0006-509002d7ac46-9f5b-4c7b-ad06-a3533ddae37712024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-5090WINREVAIR (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
0006-5068-99000065068991 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
0006-5079-89000065079891 mL in 1 SYRINGE1 mlHistorical
0006-5090-01000065090011 KIT in 1 CARTON (0006-5090-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0006-5068-99) * 1 mL in 1 SYRINGE (0006-5079-89) 1 kit2024-03-26NoNoCurrent