FDA.reportPublic FDA data

EYLEA HD

Product NDC
61755-051
11-digit product format
617550051
Labeler code
61755
Product ID
61755-051_c6550964-b64e-42e9-a3b2-dd682b1dfbbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aflibercept
Dosage form
INJECTION, SOLUTION
Route
INTRAVITREAL
Labeler
Regeneron Pharmaceuticals, Inc
Application
BLA761355
Marketing category
BLA
Marketing start
2023-08-18
Substance
AFLIBERCEPT
Active strength
8 mg/.07mL
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
EYLEA HD
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AFLIBERCEPT8 mg/.07mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15C2VL427D
Rxcui2645305, 2645308

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61755-051-00EYLEA HD0.07 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION0.0712
61755-051-01EYLEA HD1 in 1 CARTONINJECTION, SOLUTION112
61755-051-50EYLEA HD0.07 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION0.0712
61755-051-51EYLEA HD1 in 1 CARTONINJECTION, SOLUTION112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61755-051EYLEA HD (AFLIBERCEPT) INJECTION, SOLUTION [REGENERON PHARMACEUTICALS, INC]9Current NDC, 4 package rows20241024_86d8848b-111b-4da9-8957-7cccef1b8f66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2645305aflibercept 8 MG in 0.07 ML InjectionPSN86d8848b-111b-4da9-8957-7cccef1b8f6612
2645308EYLEA HD 8 MG in 0.07 ML InjectionPSN86d8848b-111b-4da9-8957-7cccef1b8f6612
26453080.07 ML aflibercept 114 MG/ML Injection [Eylea]SBD86d8848b-111b-4da9-8957-7cccef1b8f6612
26453050.07 ML aflibercept 114 MG/ML InjectionSCD86d8848b-111b-4da9-8957-7cccef1b8f6612
2645305aflibercept 114.3 MG/ML per 0.07 ML InjectionSY86d8848b-111b-4da9-8957-7cccef1b8f6612
2645305aflibercept 8 MG per 0.07 ML InjectionSY86d8848b-111b-4da9-8957-7cccef1b8f6612
2645308Eylea 114.3 MG/ML per 0.07 ML InjectionSY86d8848b-111b-4da9-8957-7cccef1b8f6612
2645308Eylea 8 MG per 0.07 ML InjectionSY86d8848b-111b-4da9-8957-7cccef1b8f6612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61755-051-00617550051000.07 mL in 1 VIAL, SINGLE-DOSE0.07 mlHistorical
61755-051-01617550051011 VIAL, SINGLE-DOSE in 1 CARTON (61755-051-01) / .07 mL in 1 VIAL, SINGLE-DOSE (61755-051-00) 2023-08-18NoNoCurrent
61755-051-50617550051500.07 mL in 1 VIAL, SINGLE-DOSE0.07 mlHistorical
61755-051-51617550051511 VIAL, SINGLE-DOSE in 1 CARTON (61755-051-51) / .07 mL in 1 VIAL, SINGLE-DOSE (61755-051-50) 2023-08-18NoNoCurrent