FDA.reportPublic FDA data

PAVBLU

Product NDC
55513-056
11-digit product format
555130056
Labeler code
55513
Product ID
55513-056_1c5a6878-6bc7-47c3-8d97-39c466cbab1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aflibercept-ayyh
Dosage form
INJECTION, SOLUTION
Route
INTRAVITREAL
Labeler
Amgen, Inc
Application
BLA761298
Marketing category
BLA
Marketing start
2024-10-28
Substance
AFLIBERCEPT
Active strength
2 mg/.05mL
Pharmacologic classes
Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AFLIBERCEPT2 mg/.05mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15C2VL427DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2696260Internal RxNorm lookup
2696267Internal RxNorm lookup
2696270Internal RxNorm lookup
2696274Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c61062f3-80ec-4a20-8c28-46e468592a06Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45d073be-8495-4765-a25a-358ca5c6ee13Product name120250516
f7afb9c5-b366-4c4e-a112-2c667c0bcd8eProduct name120190807
71c97ffd-612a-44e6-8307-e1fe87b9db9cProduct name120150923

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-056-01PAVBLU0.05 mL in 1 SYRINGEINJECTION, SOLUTION0.059
55513-056-01PAVBLU1 in 1 CARTONINJECTION, SOLUTION19
55513-056-96PAVBLU1 in 1 CARTONINJECTION, SOLUTION19
55513-056-96PAVBLU0.05 mL in 1 SYRINGEINJECTION, SOLUTION0.059

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-056-01ML - Milliliter55513-05609c7c078-be29-4f62-b062-3357449c55f712024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-056PAVBLU (AFLIBERCEPT-AYYH) INJECTION, SOLUTION [AMGEN, INC]6Current NDC, 4 package rows20250309_c61062f3-80ec-4a20-8c28-46e468592a06.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761298Pavbluaflibercept-ayyh351(k) InterchangeableRx2026-10-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2696270aflibercept-ayyh 2 MG in 0.05 ML InjectionPSNc61062f3-80ec-4a20-8c28-46e468592a069
2696260aflibercept-ayyh 2 MG in 0.05 ML Prefilled SyringePSNc61062f3-80ec-4a20-8c28-46e468592a069
2696274PAVBLU 2 MG in 0.05 ML InjectionPSNc61062f3-80ec-4a20-8c28-46e468592a069
2696267PAVBLU 2 MG in 0.05 ML Prefilled SyringePSNc61062f3-80ec-4a20-8c28-46e468592a069
26962740.05 ML aflibercept-ayyh 40 MG/ML Injection [Pavblu]SBDc61062f3-80ec-4a20-8c28-46e468592a069
26962670.05 ML aflibercept-ayyh 40 MG/ML Prefilled Syringe [Pavblu]SBDc61062f3-80ec-4a20-8c28-46e468592a069
26962700.05 ML aflibercept-ayyh 40 MG/ML InjectionSCDc61062f3-80ec-4a20-8c28-46e468592a069
26962600.05 ML aflibercept-ayyh 40 MG/ML Prefilled SyringeSCDc61062f3-80ec-4a20-8c28-46e468592a069
26962740.05 ML Pavblu 40 MG/ML InjectionSYc61062f3-80ec-4a20-8c28-46e468592a069
26962670.05 ML Pavblu 40 MG/ML Prefilled SyringeSYc61062f3-80ec-4a20-8c28-46e468592a069
2696270aflibercept-ayyh 2 MG per 0.05 ML InjectionSYc61062f3-80ec-4a20-8c28-46e468592a069
2696260aflibercept-ayyh 2 MG per 0.05 ML Prefilled SyringeSYc61062f3-80ec-4a20-8c28-46e468592a069
2696274Pavblu 2 MG per 0.05 ML InjectionSYc61062f3-80ec-4a20-8c28-46e468592a069
2696267Pavblu 2 MG per 0.05 ML Prefilled SyringeSYc61062f3-80ec-4a20-8c28-46e468592a069

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55513-056-01555130056011 SYRINGE in 1 CARTON (55513-056-01) / .05 mL in 1 SYRINGE1 syringe2024-10-28NoNoCurrent
55513-056-96555130056961 SYRINGE in 1 CARTON (55513-056-96) / .05 mL in 1 SYRINGE1 syringe2024-10-28NoNoCurrent