ENBREL

Product NDC: 50090-3531
Requested package NDC: 50090-3531-0
11-digit product format: 500903531
Labeler code: 50090
Product ID: 50090-3531_50bf9d27-2733-4e71-8393-94a0fc532692
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: etanercept
Dosage form: SOLUTION
Route: SUBCUTANEOUS
Labeler: A-S Medication Solutions
Application: BLA103795
Marketing category: BLA
Marketing start: 2005-11-10
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-3531	50090-3531-0	I	Inactivated by FDA		2026-09-14

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 · 17 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2020-12-18 03:04 UTC · source 2020-12-17	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0697f697-4635-4024-bcc8-bd30a9e66f12	Product name	1	20161228
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-3531-0	2023-01-30	C162847	48780-1	9d75b9d0-0ad2-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. ENBREL ® (etanercept) injection, for subcutaneous use ENBREL ® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 1998
50090-3531-0	2021-03-01	C162847	48780-1	9d75b9d0-0ad2-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. ENBREL ® (etanercept) injection, for subcutaneous use ENBREL ® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 1998
50090-3531-0	2020-01-31	C162847	48780-1	9d75b9d0-0ad2-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. ENBREL ® (etanercept) injection, for subcutaneous use ENBREL ® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-3531-0	ENBREL	1 mL in 1 KIT	SOLUTION	1		11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3531	ENBREL (ETANERCEPT) SOLUTION [A-S MEDICATION SOLUTIONS]	11	Legacy NDC, 1 package rows	20210617_74bead6e-b746-4134-817f-0c053ef9e451.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

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	2026-08-01

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
1653225	Enbrel 50 MG in 1 mL Auto-Injector	PSN	74bead6e-b746-4134-817f-0c053ef9e451	11
1653223	etanercept 50 MG in 1 mL Auto-Injector	PSN	74bead6e-b746-4134-817f-0c053ef9e451	11
1653225	1 ML etanercept 50 MG/ML Auto-Injector [Enbrel]	SBD	74bead6e-b746-4134-817f-0c053ef9e451	11
1653223	1 ML etanercept 50 MG/ML Auto-Injector	SCD	74bead6e-b746-4134-817f-0c053ef9e451	11
1653225	1 ML Enbrel 50 MG/ML Auto-Injector	SY	74bead6e-b746-4134-817f-0c053ef9e451	11
1653223	etanercept 50 MG per 1 ML Auto-Injector	SY	74bead6e-b746-4134-817f-0c053ef9e451	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3531-0	50090353100	1 mL in 1 KIT (50090-3531-0)	1 ml	2018-08-01	0000-00-00	No	No	Current