ENBREL

Product NDC: 50090-3531
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

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

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

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

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

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

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

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