ENBREL

Product NDC: 58406-456
Requested package NDC: 58406-456-04
11-digit product format: 584060456
Labeler code: 58406
Product ID: 58406-456_e4897db8-5f5d-4216-b8ac-dbada29e8709
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: etanercept
Dosage form: SOLUTION
Route: SUBCUTANEOUS
Labeler: Immunex Corporation
Application: BLA103795
Marketing category: BLA
Marketing start: 2017-09-29
Marketing end: 0000-00-00
Substance: ETANERCEPT
Active strength: 50 mg/mL
Pharmacologic classes: Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	58406-456	58406-456-04	D	Discontinued by firm		2026-08-03

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58406-456-01	ML - Milliliter	58406-456	f0192342-79e4-4e02-9c2a-b9eab3c62a05	1	2017-11-06
58406-456-04	ML - Milliliter	58406-456	2107f3ee-0a44-4fdc-80c5-723a922f52eb	1	2017-11-06

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	2026-06-01

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58406-456-04	58406045604	4 CARTRIDGE in 1 CARTON (58406-456-04) > 1 mL in 1 CARTRIDGE (58406-456-01)	4 cartridge	2017-09-29	0000-00-00	No	No	Current