Evkeeza

Product NDC: 61755-013
11-digit product format: 617550013
Labeler code: 61755
Product ID: 61755-013_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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
EVINACUMAB	150 mg/mL

Field, Values table
Field	Values
Unii	T8B2ORP1DW
Rxcui	2478648, 2478650, 2478731, 2478732

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
315cab88-8f17-412f-a6e8-5e4cdfc4d40f	Product name	1	20210727
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61755-013-01	Evkeeza	1 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	1		5
61755-013-01	Evkeeza	2.3 mL in 1 VIAL, SINGLE-USE	INJECTION, SOLUTION, CONCENTRATE	2.3		5

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61755-013-01	ML - Milliliter	61755-013	a2f5c7b3-87d8-4d9f-ac8f-9e1b562c9b6d	1	2021-03-02

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61755-013	EVKEEZA (EVINACUMAB) INJECTION, SOLUTION, CONCENTRATE [REGENERON PHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20250115_73412138-6d8f-4ea6-bb72-a740190470ff.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
T8B2ORP1DW	EVINACUMAB	1446419-85-7	EVINACUMAB

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2478731	evinacumab-dgnb 1200 MG in 8 ML Injection	PSN	73412138-6d8f-4ea6-bb72-a740190470ff	5
2478648	evinacumab-dgnb 345 MG in 2.3 ML Injection	PSN	73412138-6d8f-4ea6-bb72-a740190470ff	5
2478732	Evkeeza 1200 MG in 8 ML Injection	PSN	73412138-6d8f-4ea6-bb72-a740190470ff	5
2478650	Evkeeza 345 MG in 2.3 ML Injection	PSN	73412138-6d8f-4ea6-bb72-a740190470ff	5
2478650	2.3 ML evinacumab-dgnb 150 MG/ML Injection [Evkeeza]	SBD	73412138-6d8f-4ea6-bb72-a740190470ff	5
2478732	8 ML evinacumab-dgnb 150 MG/ML Injection [Evkeeza]	SBD	73412138-6d8f-4ea6-bb72-a740190470ff	5
2478648	2.3 ML evinacumab-dgnb 150 MG/ML Injection	SCD	73412138-6d8f-4ea6-bb72-a740190470ff	5
2478731	8 ML evinacumab-dgnb 150 MG/ML Injection	SCD	73412138-6d8f-4ea6-bb72-a740190470ff	5
2478732	8 ML Evkeeza 150 MG/ML Injection	SY	73412138-6d8f-4ea6-bb72-a740190470ff	5
2478731	evinacumab-dgnb 1200 MG per 8 ML Injection	SY	73412138-6d8f-4ea6-bb72-a740190470ff	5
2478648	evinacumab-dgnb 345 MG per 2.3 ML Injection	SY	73412138-6d8f-4ea6-bb72-a740190470ff	5
2478732	Evkeeza 1200 MG per 8 ML Injection	SY	73412138-6d8f-4ea6-bb72-a740190470ff	5
2478650	Evkeeza 345 MG per 2.3 ML Injection	SY	73412138-6d8f-4ea6-bb72-a740190470ff	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61755-013-01	61755001301	1 VIAL, SINGLE-USE in 1 CARTON (61755-013-01) / 2.3 mL in 1 VIAL, SINGLE-USE	2021-02-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Evkeeza	Regeneron Pharmaceuticals, Inc. \| Regn Ireland DAC	2025-09-25	HUMAN PRESCRIPTION DRUG LABEL	5