NDC 58406-021

ENBREL

Etanercept

ENBREL is a Subcutaneous Solution in the Human Prescription Drug category. It is labeled and distributed by Immunex Corporation. The primary component is Etanercept.

• Product ID: 58406-021_1bac748e-3ec9-4007-bd9a-541067a7567a
• NDC: 58406-021
• Product Type: Human Prescription Drug
• Proprietary Name: ENBREL
• Generic Name: Etanercept
• Dosage Form: Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2019-06-07
• Marketing Category: BLA / BLA
• Application Number: BLA103795
• Labeler Name: Immunex Corporation
• Substance Name: ETANERCEPT
• Active Ingredient Strength: 50 mg/mL
• Pharm Classes: Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 58406-021-04

4 SYRINGE in 1 CARTON (58406-021-04) > 1 mL in 1 SYRINGE (58406-021-01)

• Marketing Start Date: 2019-06-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58406-021-04 [58406002104]

ENBREL SOLUTION

• Marketing Category: BLA
• Application Number: BLA103795
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-06-07

NDC 58406-021-01 [58406002101]

ENBREL SOLUTION

• Marketing Category: BLA
• Application Number: BLA103795
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-06-07

Drug Details

Active Ingredients

Ingredient	Strength
ETANERCEPT	50 mg/mL

OpenFDA Data

• SPL SET ID: a002b40c-097d-47a5-957f-7a7b1807af7f
• Manufacturer:
  • Immunex Corporation
• UNII:
  • OP401G7OJC
• RxNorm Concept Unique ID - RxCUI:
  • 802652
  • 1653225
  • 809159
  • 809158
  • 261105
  • 253014
  • 1653223
  • 727757

Pharmacological Class

• Tumor Necrosis Factor Blocker [EPC]
• Tumor Necrosis Factor Receptor Blocking Activity [MoA]

NDC Crossover Matching brand name "ENBREL" or generic name "Etanercept"

NDC	Brand Name	Generic Name
50090-3531	ENBREL	etanercept
50090-4490	ENBREL	etanercept
50090-4590	ENBREL	etanercept
58406-010	ENBREL	etanercept
58406-021	ENBREL	etanercept
58406-032	ENBREL	etanercept
58406-044	ENBREL	etanercept
58406-455	ENBREL	ENBREL
58406-456	ENBREL	ENBREL
58406-425	ENBREL	ENBREL
58406-435	ENBREL	ENBREL
58406-445	ENBREL	ENBREL
58406-446	ENBREL	ENBREL
58406-055	ENBREL	ENBREL