FDA.reportPublic FDA data

PAVBLU

Product NDC
55513-065
11-digit product format
555130065
Labeler code
55513
Product ID
55513-065_04e11a27-3d29-4776-bd2f-139a952423fe
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

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
55513-065-01PAVBLU0.05 mL in 1 VIALINJECTION, SOLUTION0.059
55513-065-01PAVBLU1 in 1 CARTONINJECTION, SOLUTION19
55513-065-96PAVBLU1 in 1 CARTONINJECTION, SOLUTION19
55513-065-96PAVBLU0.05 mL in 1 VIALINJECTION, SOLUTION0.059

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-065-01ML - Milliliter55513-0655eff44a7-ba70-413f-8464-8bedb3d091c012024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-065PAVBLU (AFLIBERCEPT-AYYH) INJECTION, SOLUTION [AMGEN, INC]6Current NDC, 4 package rows20250309_c61062f3-80ec-4a20-8c28-46e468592a06.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
PAVBLUAFLIBERCEPT-AYYHAmgen, Incc61062f3-80ec-4a20-8c28-46e468592a062026-05-10Warnings, Adverse reactionsExact identifier
application number: BLA761298
ndc (product): 55513-065

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761298Pavbluaflibercept-ayyh351(k) BiosimilarRx2026-06-01

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
55513-065-01555130065011 VIAL in 1 CARTON (55513-065-01) / .05 mL in 1 VIAL1 vial2024-10-28NoNoCurrent
55513-065-96555130065961 VIAL in 1 CARTON (55513-065-96) / .05 mL in 1 VIAL1 vial2024-10-28NoNoCurrent