FDA.reportPublic FDA data

WINREVAIR

Product NDC
0006-5088
11-digit product format
000065088
Labeler code
0006
Product ID
0006-5088_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 Identifiers#

Field, Values table
FieldValues
Rxcui2678937, 2678943, 2678945, 2678947, 2678948, 2678949, 2678950, 2678951

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,2 mL60 mg in 1mL8
0006-5080-89WINREVAIR1.3 mL in 1 SYRINGEINJECTION, SOLUTION2.6 mL1.3 mL in 1.3mL8
0006-5088-01WINREVAIR1 in 1 CARTONKIT18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-5088-01EA - Each0006-5088d8239845-7dba-4151-a09b-5757537b99a512024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-5088WINREVAIR (SOTATERCEPT-CSRK) KIT [MERCK SHARP & DOHME LLC]4Current NDC, 3 package rows20250507_21693ee2-cd23-4137-ac67-066bb3a4a9b7.zip

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
0006-5088-01000065088011 KIT in 1 CARTON (0006-5088-01) * 1 mL in 1 VIAL, SINGLE-DOSE (0006-5069-99) * 1.3 mL in 1 SYRINGE (0006-5080-89) 1 kit2024-03-26NoNoHistorical