KEVZARA

Product NDC: 0024-5920
11-digit product format: 000245920
Labeler code: 0024
Product ID: 0024-5920_b1eeca31-be2b-4c68-a7c0-220256a2b906
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sarilumab
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Sanofi-Aventis U.S. LLC
Application: BLA761037
Marketing category: BLA
Marketing start: 2017-05-22
Substance: SARILUMAB
Active strength: 150 mg/1.14mL
Pharmacologic classes: Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: KEVZARA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SARILUMAB	150 mg/1.14mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NU90V55F8I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1923333	Internal RxNorm lookup
1923338	Internal RxNorm lookup
1923345	Internal RxNorm lookup
1923347	Internal RxNorm lookup
2003755	Internal RxNorm lookup
2003757	Internal RxNorm lookup
2003766	Internal RxNorm lookup
2003767	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
827bc01c-d379-4266-a18c-c7f904b76af3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
729dde70-00cc-4ad7-bfd2-1334695b7e99	Product name	1	20170719
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0024-5920-00	KEVZARA	1.14 mL in 1 SYRINGE	INJECTION, SOLUTION	1.14	15
0024-5920-01	KEVZARA	2 in 1 PACKAGE	INJECTION, SOLUTION	2	15
0024-5920-02	KEVZARA	2 in 1 PACKAGE	INJECTION, SOLUTION	2	15
0024-5920-02	KEVZARA	1.14 mL in 1 SYRINGE	INJECTION, SOLUTION	1.14	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0024-5920-01	ML - Milliliter	0024-5920	4f81e871-5d16-4243-8d69-a0d16b8c2d25	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0024-5920	KEVZARA (SARILUMAB) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]	14	Current NDC, Legacy NDC, 4 package rows	20250523_827bc01c-d379-4266-a18c-c7f904b76af3.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KEVZARA	SARILUMAB	Sanofi-Aventis U.S. LLC	827bc01c-d379-4266-a18c-c7f904b76af3	2026-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA761037 ndc (product): 0024-5920

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761037	Kevzara	sarilumab	351(a)	Rx	2026-06-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NU90V55F8I	SARILUMAB	1189541-98-7	SARILUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2003757	KEVZARA 150 MG in 1.14 mL Auto-Injector	PSN	827bc01c-d379-4266-a18c-c7f904b76af3	15
1923338	KEVZARA 150 MG in 1.14 mL Prefilled Syringe	PSN	827bc01c-d379-4266-a18c-c7f904b76af3	15
2003767	KEVZARA 200 MG in 1.14 mL Auto-Injector	PSN	827bc01c-d379-4266-a18c-c7f904b76af3	15
1923347	KEVZARA 200 MG in 1.14 mL Prefilled Syringe	PSN	827bc01c-d379-4266-a18c-c7f904b76af3	15
2003755	sarilumab 150 MG in 1.14 ML Auto-Injector	PSN	827bc01c-d379-4266-a18c-c7f904b76af3	15
1923333	sarilumab 150 MG in 1.14 mL Prefilled Syringe	PSN	827bc01c-d379-4266-a18c-c7f904b76af3	15
2003766	sarilumab 200 MG in 1.14 mL Auto-Injector	PSN	827bc01c-d379-4266-a18c-c7f904b76af3	15
1923345	sarilumab 200 MG in 1.14 mL Prefilled Syringe	PSN	827bc01c-d379-4266-a18c-c7f904b76af3	15
2003757	1.14 ML sarilumab 132 MG/ML Auto-Injector [Kevzara]	SBD	827bc01c-d379-4266-a18c-c7f904b76af3	15
1923338	1.14 ML sarilumab 132 MG/ML Prefilled Syringe [Kevzara]	SBD	827bc01c-d379-4266-a18c-c7f904b76af3	15
2003767	1.14 ML sarilumab 175 MG/ML Auto-Injector [Kevzara]	SBD	827bc01c-d379-4266-a18c-c7f904b76af3	15
1923347	1.14 ML sarilumab 175 MG/ML Prefilled Syringe [Kevzara]	SBD	827bc01c-d379-4266-a18c-c7f904b76af3	15
2003755	1.14 ML sarilumab 132 MG/ML Auto-Injector	SCD	827bc01c-d379-4266-a18c-c7f904b76af3	15
1923333	1.14 ML sarilumab 132 MG/ML Prefilled Syringe	SCD	827bc01c-d379-4266-a18c-c7f904b76af3	15
2003766	1.14 ML sarilumab 175 MG/ML Auto-Injector	SCD	827bc01c-d379-4266-a18c-c7f904b76af3	15
1923345	1.14 ML sarilumab 175 MG/ML Prefilled Syringe	SCD	827bc01c-d379-4266-a18c-c7f904b76af3	15
2003757	1.14 ML Kevzara 132 MG/ML Auto-Injector	SY	827bc01c-d379-4266-a18c-c7f904b76af3	15
1923338	1.14 ML Kevzara 132 MG/ML Prefilled Syringe	SY	827bc01c-d379-4266-a18c-c7f904b76af3	15
2003767	1.14 ML Kevzara 175 MG/ML Auto-Injector	SY	827bc01c-d379-4266-a18c-c7f904b76af3	15
1923347	1.14 ML Kevzara 175 MG/ML Prefilled Syringe	SY	827bc01c-d379-4266-a18c-c7f904b76af3	15
2003757	Kevzara 150 MG per 1.14 ML Auto-Injector	SY	827bc01c-d379-4266-a18c-c7f904b76af3	15
1923338	Kevzara 150 MG per 1.14 ML Prefilled Syringe	SY	827bc01c-d379-4266-a18c-c7f904b76af3	15
2003767	Kevzara 200 MG per 1.14 ML Auto-Injector	SY	827bc01c-d379-4266-a18c-c7f904b76af3	15
1923347	Kevzara 200 MG per 1.14 ML Prefilled Syringe	SY	827bc01c-d379-4266-a18c-c7f904b76af3	15
2003755	sarilumab 150 MG per 1.14 ML Auto-Injector	SY	827bc01c-d379-4266-a18c-c7f904b76af3	15
1923333	sarilumab 150 MG per 1.14 ML Prefilled Syringe	SY	827bc01c-d379-4266-a18c-c7f904b76af3	15
2003766	sarilumab 200 MG in 1.14 mL Auto-Injector	SY	827bc01c-d379-4266-a18c-c7f904b76af3	15
1923345	sarilumab 200 MG per 1.14 ML Prefilled Syringe	SY	827bc01c-d379-4266-a18c-c7f904b76af3	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0024-5920-00	00024592000	1.14 mL in 1 SYRINGE	1.14 ml					Historical
0024-5920-01	00024592001	2 SYRINGE in 1 PACKAGE (0024-5920-01) / 1.14 mL in 1 SYRINGE (0024-5920-00)	2 syringe	2018-04-13	0000-00-00	No	No	Current
0024-5920-02	00024592002	2 SYRINGE in 1 PACKAGE (0024-5920-02) / 1.14 mL in 1 SYRINGE	2 syringe	2018-04-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KEVZARA	Sanofi-Aventis U.S. LLC \| Sanofi Winthrop Industrie \| Sanofi-Aventis Deutschland GmbH \| Regeneron Pharmaceuticals, Inc. \| Genzyme Corporation \| Genzyme Ireland Limited \| Nelson Laboratories, LLC	2026-02-27	HUMAN PRESCRIPTION DRUG LABEL	15