ENBREL

Product NDC: 58406-425
11-digit product format: 584060425
Labeler code: 58406
Product ID: 58406-425_e4897db8-5f5d-4216-b8ac-dbada29e8709
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: etanercept
Dosage form: KIT
Labeler: Immunex Corporation
Application: BLA103795
Marketing category: BLA
Marketing start: 2003-01-02
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	58406-425		D	Discontinued by firm		2026-08-17
excluded package	package	58406-425	58406-425-34	D	Discontinued by firm		2026-08-17

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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58406-425-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58406-425-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58406-425-34	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58406-425-34	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58406-425-34	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58406-425-34	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58406-425-34	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58406-425-34	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58406-425-34	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58406-425-34	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58406-425-34	`367a005e9d99…`	`383a685ebd0f…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
0697f697-4635-4024-bcc8-bd30a9e66f12	Product name	1	20161228
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58406-424-01	ENBREL	1 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	1 mL	25 mg in 1mL	218
58406-425-34	ENBREL	4 in 1 CARTON	KIT	4		218
58406-425-41	ENBREL	1 in 1 KIT	KIT	1		218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58406-425-34	EA - Each	58406-425	3d0f753a-b49f-4237-a137-981415eee59e	1	2012-07-24
58406-425-41	EA - Each	58406-425	64f02147-c3ef-4cac-8c49-896631535cff	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETANERCEPT	ACTIVE INGREDIENT	OP401G7OJC	ENBREL (ETANERCEPT) SOLUTION ENBREL (ETANERCEPT) KIT [IMMUNEX CORPORATION]	165
ETANERCEPT	ACTIVE MOIETY	OP401G7OJC	ENBREL (ETANERCEPT) SOLUTION ENBREL (ETANERCEPT) KIT [IMMUNEX CORPORATION]	165
ARGININE HYDROCHLORIDE	INACTIVE INGREDIENT	F7LTH1E20Y	ENBREL (ETANERCEPT) SOLUTION ENBREL (ETANERCEPT) KIT [IMMUNEX CORPORATION]	165
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ENBREL (ETANERCEPT) SOLUTION ENBREL (ETANERCEPT) KIT [IMMUNEX CORPORATION]	165
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ENBREL (ETANERCEPT) SOLUTION ENBREL (ETANERCEPT) KIT [IMMUNEX CORPORATION]	165
SODIUM PHOSPHATE	INACTIVE INGREDIENT	SE337SVY37	ENBREL (ETANERCEPT) SOLUTION ENBREL (ETANERCEPT) KIT [IMMUNEX CORPORATION]	165
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ENBREL (ETANERCEPT) SOLUTION ENBREL (ETANERCEPT) KIT [IMMUNEX CORPORATION]	165
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	ENBREL (ETANERCEPT) SOLUTION ENBREL (ETANERCEPT) KIT [IMMUNEX CORPORATION]	165

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58406-425	ENBREL (ETANERCEPT) KIT ENBREL (ETANERCEPT) SOLUTION [IMMUNEX CORPORATION]	211	Legacy NDC, 3 package rows	20250305_a002b40c-097d-47a5-957f-7a7b1807af7f.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
ENBREL	ETANERCEPT	Immunex Corporation	a002b40c-097d-47a5-957f-7a7b1807af7f	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA103795 ndc (product): 58406-425

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103795	Enbrel	etanercept	351(a)	Disc	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
OP401G7OJC	ETANERCEPT	185243-69-0	etanercept

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2392142	Enbrel 25 MG in 0.5 mL Injection	PSN	a002b40c-097d-47a5-957f-7a7b1807af7f	218
809159	Enbrel 25 MG in 0.5 mL Prefilled Syringe	PSN	a002b40c-097d-47a5-957f-7a7b1807af7f	218
261105	Enbrel 25 MG/ML Injectable Solution	PSN	a002b40c-097d-47a5-957f-7a7b1807af7f	218
1653225	Enbrel 50 MG in 1 mL Auto-Injector	PSN	a002b40c-097d-47a5-957f-7a7b1807af7f	218
2182340	Enbrel 50 MG in 1 mL Cartridge	PSN	a002b40c-097d-47a5-957f-7a7b1807af7f	218
802652	Enbrel 50 MG in 1 mL Prefilled Syringe	PSN	a002b40c-097d-47a5-957f-7a7b1807af7f	218
2392140	etanercept 25 MG in 0.5 ML Injection	PSN	a002b40c-097d-47a5-957f-7a7b1807af7f	218
809158	etanercept 25 MG in 0.5 mL Prefilled Syringe	PSN	a002b40c-097d-47a5-957f-7a7b1807af7f	218
253014	etanercept 25 MG/ML Injectable Solution	PSN	a002b40c-097d-47a5-957f-7a7b1807af7f	218
1653223	etanercept 50 MG in 1 mL Auto-Injector	PSN	a002b40c-097d-47a5-957f-7a7b1807af7f	218
2182338	etanercept 50 MG in 1 mL Cartridge	PSN	a002b40c-097d-47a5-957f-7a7b1807af7f	218
2392142	0.5 ML etanercept 50 MG/ML Injection [Enbrel]	SBD	a002b40c-097d-47a5-957f-7a7b1807af7f	218
809159	0.5 ML etanercept 50 MG/ML Prefilled Syringe [Enbrel]	SBD	a002b40c-097d-47a5-957f-7a7b1807af7f	218
1653225	1 ML etanercept 50 MG/ML Auto-Injector [Enbrel]	SBD	a002b40c-097d-47a5-957f-7a7b1807af7f	218
2182340	1 ML etanercept 50 MG/ML Cartridge [Enbrel]	SBD	a002b40c-097d-47a5-957f-7a7b1807af7f	218
802652	1 ML etanercept 50 MG/ML Prefilled Syringe [Enbrel]	SBD	a002b40c-097d-47a5-957f-7a7b1807af7f	218
261105	etanercept 25 MG/ML Injectable Solution [Enbrel]	SBD	a002b40c-097d-47a5-957f-7a7b1807af7f	218
2392140	0.5 ML etanercept 50 MG/ML Injection	SCD	a002b40c-097d-47a5-957f-7a7b1807af7f	218
809158	0.5 ML etanercept 50 MG/ML Prefilled Syringe	SCD	a002b40c-097d-47a5-957f-7a7b1807af7f	218
1653223	1 ML etanercept 50 MG/ML Auto-Injector	SCD	a002b40c-097d-47a5-957f-7a7b1807af7f	218
2182338	1 ML etanercept 50 MG/ML Cartridge	SCD	a002b40c-097d-47a5-957f-7a7b1807af7f	218
727757	1 ML etanercept 50 MG/ML Prefilled Syringe	SCD	a002b40c-097d-47a5-957f-7a7b1807af7f	218
253014	etanercept 25 MG/ML Injectable Solution	SCD	a002b40c-097d-47a5-957f-7a7b1807af7f	218
2392142	0.5 ML Enbrel 50 MG/ML Injection	SY	a002b40c-097d-47a5-957f-7a7b1807af7f	218
809159	0.5 ML Enbrel 50 MG/ML Prefilled Syringe	SY	a002b40c-097d-47a5-957f-7a7b1807af7f	218
1653225	1 ML Enbrel 50 MG/ML Auto-Injector	SY	a002b40c-097d-47a5-957f-7a7b1807af7f	218
2182340	1 ML Enbrel 50 MG/ML Cartridge	SY	a002b40c-097d-47a5-957f-7a7b1807af7f	218
802652	1 ML Enbrel 50 MG/ML Prefilled Syringe	SY	a002b40c-097d-47a5-957f-7a7b1807af7f	218
2392142	Enbrel 25 MG per 0.5 mL Injection	SY	a002b40c-097d-47a5-957f-7a7b1807af7f	218
261105	Enbrel 25 MG/ML Injectable Solution	SY	a002b40c-097d-47a5-957f-7a7b1807af7f	218
2182340	Enbrel 50 MG per 1 ML Cartridge	SY	a002b40c-097d-47a5-957f-7a7b1807af7f	218
2392140	etanercept 25 MG per 0.5 ML Injection	SY	a002b40c-097d-47a5-957f-7a7b1807af7f	218
809158	etanercept 25 MG per 0.5 ML Prefilled Syringe	SY	a002b40c-097d-47a5-957f-7a7b1807af7f	218
1653223	etanercept 50 MG per 1 ML Auto-Injector	SY	a002b40c-097d-47a5-957f-7a7b1807af7f	218
2182338	etanercept 50 MG per 1 ML Cartridge	SY	a002b40c-097d-47a5-957f-7a7b1807af7f	218
809158	etanercept 50 MG/ML per 0.5 ML Prefilled Syringe	SY	a002b40c-097d-47a5-957f-7a7b1807af7f	218

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58406-424-01	58406042401	1 mL in 1 VIAL	1 ml					Historical
58406-425-34	58406042534	4 KIT in 1 CARTON (58406-425-34) > 1 KIT in 1 KIT (58406-425-41) * 1 mL in 1 VIAL (58406-424-01) * 1 mL in 1 SYRINGE (58406-910-01)	4 kit	2003-01-02	0000-00-00	No	No	Current
58406-425-41	58406042541	1 in 1 KIT						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ENBREL	Immunex Corporation \| Amgen Manufacturing Limited LLC	2026-05-11	HUMAN PRESCRIPTION DRUG LABEL	218