FDA.reportPublic FDA data

EYLEA HD

Product NDC
61755-050
11-digit product format
617550050
Labeler code
61755
Product ID
61755-050_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 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2645305Internal RxNorm lookup
2645308Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
86d8848b-111b-4da9-8957-7cccef1b8f66Available 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
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
61755-050-00EYLEA HD0.07 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION0.0712
61755-050-01EYLEA HD1 in 1 CARTONINJECTION, SOLUTION112
61755-050-50EYLEA HD0.07 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION0.0712
61755-050-51EYLEA HD1 in 1 CARTONINJECTION, SOLUTION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61755-050-00ML - Milliliter61755-0506af71344-297b-4902-a07d-a7d80952943512023-10-16
61755-050-01ML - Milliliter61755-05013d0737f-6f7a-4e9b-8c29-96050b35bdc512023-09-05
61755-050-51ML - Milliliter61755-0500adba0e3-198c-45ad-9b56-0103dcb56e7612025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61755-050EYLEA HD (AFLIBERCEPT) INJECTION, SOLUTION [REGENERON PHARMACEUTICALS, INC]9Current NDC, 4 package rows20241024_86d8848b-111b-4da9-8957-7cccef1b8f66.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
EYLEA HDAFLIBERCEPTRegeneron Pharmaceuticals, Inc86d8848b-111b-4da9-8957-7cccef1b8f662026-04-06Warnings, Adverse reactionsExact identifier
application number: BLA761355
ndc (product): 61755-050

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761355Eylea HDaflibercept351(a)Rx2026-06-01

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
61755-050-00617550050000.07 mL in 1 VIAL, SINGLE-DOSE0.07 mlHistorical
61755-050-01617550050011 VIAL, SINGLE-DOSE in 1 CARTON (61755-050-01) / .07 mL in 1 VIAL, SINGLE-DOSE (61755-050-00) 2023-08-18NoNoCurrent
61755-050-50617550050500.07 mL in 1 VIAL, SINGLE-DOSE0.07 mlHistorical
61755-050-51617550050511 VIAL, SINGLE-DOSE in 1 CARTON (61755-050-51) / .07 mL in 1 VIAL, SINGLE-DOSE (61755-050-50) 2023-08-18NoNoCurrent