FDA.reportPublic FDA data

Abrysvo

Product NDC
0069-0344
11-digit product format
000690344
Labeler code
0069
Product ID
0069-0344_22c6b04d-858c-4a16-9593-5643aabb0da9
Type
VACCINE
Nonproprietary name
Respiratory Syncytial Virus Vaccine
Dosage form
KIT
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
BLA125769
Marketing category
BLA
Marketing start
2023-07-12
Marketing end
2026-05-31
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0069-0344DDiscontinued by firm2026-07-31
excluded packagepackage0069-03440069-0344-01DDiscontinued by firm2026-07-31
excluded packagepackage0069-03440069-0344-05DDiscontinued by firm2026-07-31
excluded packagepackage0069-03440069-0344-10DDiscontinued by firm2026-07-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-0207-01Abrysvo0.5 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,0.5 mL0.06 mg in 0.5mL14
0069-0344-01Abrysvo1 in 1 CARTONKIT114
0069-0344-05Abrysvo5 in 1 CARTONKIT514
0069-0344-10Abrysvo10 in 1 CARTONKIT1014
0069-0344-21Abrysvo1 in 1 TRAYKIT114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0344-01EA - Each0069-0344fd89b19c-d8ae-4405-ab45-870a65613c0412023-08-08
0069-0344-05EA - Each0069-0344e1c89da6-283d-4c49-857f-705b1112c16a12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0344ABRYSVO (RESPIRATORY SYNCYTIAL VIRUS VACCINE) KIT ABRYSVO (RESPIRATORY SYNCYTIAL VIRUS VACCINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]11Current NDC, 5 package rows20250112_be18292e-b1a2-4815-a0ed-003efaa6bea3.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125769AbrysvoRespiratory Syncytial Virus Vaccine351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2642148ABRYSVO 60 MCG / 60 MCG in 0.5 ML InjectionPSNbe18292e-b1a2-4815-a0ed-003efaa6bea314
2642142respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 60 MCG / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 60 MCG in 0.5 ML InjectionPSNbe18292e-b1a2-4815-a0ed-003efaa6bea314
26421480.5 ML respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 0.12 MG/ML / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 0.12 MG/ML Injection [Abrysvo]SBDbe18292e-b1a2-4815-a0ed-003efaa6bea314
26421420.5 ML respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 0.12 MG/ML / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 0.12 MG/ML InjectionSCDbe18292e-b1a2-4815-a0ed-003efaa6bea314
2642148Abrysvo 60 MCG / 60 MCG per 0.5 ML InjectionSYbe18292e-b1a2-4815-a0ed-003efaa6bea314
2642142respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 60 MCG / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 60 MCG per 0.5 ML InjectionSYbe18292e-b1a2-4815-a0ed-003efaa6bea314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0069-0207-01000690207010.5 mL in 1 VIAL, GLASS0.5 mlHistorical
0069-0344-01000690344011 TRAY in 1 CARTON (0069-0344-01) / 1 KIT in 1 TRAY (0069-0344-21) * .5 mL in 1 VIAL, GLASS (0069-0207-01) * .69 mL in 1 SYRINGE, GLASS (0069-0250-01) 1 tray2023-07-122026-05-31NoNoHistorical
0069-0344-05000690344055 TRAY in 1 CARTON (0069-0344-05) / 1 KIT in 1 TRAY (0069-0344-21) * .5 mL in 1 VIAL, GLASS (0069-0207-01) * .69 mL in 1 SYRINGE, GLASS (0069-0250-01) 5 tray2023-07-122026-05-31NoNoHistorical
0069-0344-100006903441010 TRAY in 1 CARTON (0069-0344-10) / 1 KIT in 1 TRAY (0069-0344-21) * .5 mL in 1 VIAL, GLASS (0069-0207-01) * .69 mL in 1 SYRINGE, GLASS (0069-0250-01) 10 tray2023-07-122026-05-31NoNoHistorical
0069-0344-21000690344211 in 1 TRAYHistorical