FDA.reportPublic FDA data

Evkeeza

Product NDC
61755-010
Requested package NDC
61755-010-01
11-digit product format
617550010
Labeler code
61755
Product ID
61755-010_d95d8409-4a39-4b82-954d-e055409fa892
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
evinacumab
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Regeneron Pharmaceuticals, Inc.
Application
BLA761181
Marketing category
BLA
Marketing start
2021-02-11
Substance
EVINACUMAB
Active strength
150 mg/mL
Pharmacologic classes
Angiopoietin-like 3 Inhibitor [EPC], Angiopoietin-like 3 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61755-01061755-010-01IInactivated by FDA2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61755-01061755-010-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
315cab88-8f17-412f-a6e8-5e4cdfc4d40fProduct name120210727
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
61755-010-01Evkeeza8 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION, CONCENTRATE85
61755-010-01Evkeeza1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61755-010-01ML - Milliliter61755-01050d9ae0f-ba30-4a33-8e70-ccf16253b43f12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61755-010EVKEEZA (EVINACUMAB) INJECTION, SOLUTION, CONCENTRATE [REGENERON PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20250115_73412138-6d8f-4ea6-bb72-a740190470ff.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761181Evkeezaevinacumab-dgnb351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2478731evinacumab-dgnb 1200 MG in 8 ML InjectionPSN73412138-6d8f-4ea6-bb72-a740190470ff5
2478648evinacumab-dgnb 345 MG in 2.3 ML InjectionPSN73412138-6d8f-4ea6-bb72-a740190470ff5
2478732Evkeeza 1200 MG in 8 ML InjectionPSN73412138-6d8f-4ea6-bb72-a740190470ff5
2478650Evkeeza 345 MG in 2.3 ML InjectionPSN73412138-6d8f-4ea6-bb72-a740190470ff5
24786502.3 ML evinacumab-dgnb 150 MG/ML Injection [Evkeeza]SBD73412138-6d8f-4ea6-bb72-a740190470ff5
24787328 ML evinacumab-dgnb 150 MG/ML Injection [Evkeeza]SBD73412138-6d8f-4ea6-bb72-a740190470ff5
24786482.3 ML evinacumab-dgnb 150 MG/ML InjectionSCD73412138-6d8f-4ea6-bb72-a740190470ff5
24787318 ML evinacumab-dgnb 150 MG/ML InjectionSCD73412138-6d8f-4ea6-bb72-a740190470ff5
24787328 ML Evkeeza 150 MG/ML InjectionSY73412138-6d8f-4ea6-bb72-a740190470ff5
2478731evinacumab-dgnb 1200 MG per 8 ML InjectionSY73412138-6d8f-4ea6-bb72-a740190470ff5
2478648evinacumab-dgnb 345 MG per 2.3 ML InjectionSY73412138-6d8f-4ea6-bb72-a740190470ff5
2478732Evkeeza 1200 MG per 8 ML InjectionSY73412138-6d8f-4ea6-bb72-a740190470ff5
2478650Evkeeza 345 MG per 2.3 ML InjectionSY73412138-6d8f-4ea6-bb72-a740190470ff5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61755-010-01617550010011 VIAL, SINGLE-USE in 1 CARTON (61755-010-01) / 8 mL in 1 VIAL, SINGLE-USE2021-02-110000-00-00NoNoCurrent