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

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2678937Internal RxNorm lookup
2678943Internal RxNorm lookup
2678945Internal RxNorm lookup
2678947Internal RxNorm lookup
2678948Internal RxNorm lookup
2678949Internal RxNorm lookup
2678950Internal RxNorm lookup
2678951Internal RxNorm lookup

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

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
WINREVAIRSOTATERCEPT-CSRKMerck Sharp & Dohme LLC21693ee2-cd23-4137-ac67-066bb3a4a9b72026-06-17Warnings, Adverse reactionsExact identifier
application number: BLA761363
ndc (product): 0006-5091

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761363Winrevairsotatercept-csrk351(a)Rx2026-08-01

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