MedPath
FDA Approval

AIMOVIG

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Amgen Inc
DUNS: 039976196
Effective Date
May 16, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Erenumab(70 mg in 1 mL)

Products4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

AIMOVIG

Product Details

NDC Product Code
55513-841
Application Number
BLA761077
Marketing Category
BLA (C73585)
Route of Administration
SUBCUTANEOUS
Effective Date
May 16, 2023
ErenumabActive
Code: I5I8VB78VTClass: ACTIBQuantity: 70 mg in 1 mL
ACETATE IONInactive
Code: 569DQM74SCClass: IACTQuantity: 1.5 mg in 1 mL
SUCROSEInactive
Code: C151H8M554Class: IACTQuantity: 73 mg in 1 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 0.1 mg in 1 mL

AIMOVIG

Product Details

NDC Product Code
55513-843
Application Number
BLA761077
Marketing Category
BLA (C73585)
Route of Administration
SUBCUTANEOUS
Effective Date
May 16, 2023
ErenumabActive
Code: I5I8VB78VTClass: ACTIBQuantity: 140 mg in 1 mL
SUCROSEInactive
Code: C151H8M554Class: IACTQuantity: 65 mg in 1 mL
ACETATE IONInactive
Code: 569DQM74SCClass: IACTQuantity: 2 mg in 1 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 0.1 mg in 1 mL

AIMOVIG

Product Details

NDC Product Code
55513-840
Application Number
BLA761077
Marketing Category
BLA (C73585)
Route of Administration
SUBCUTANEOUS
Effective Date
May 16, 2023
SUCROSEInactive
Code: C151H8M554Class: IACTQuantity: 73 mg in 1 mL
ErenumabActive
Code: I5I8VB78VTClass: ACTIBQuantity: 70 mg in 1 mL
ACETATE IONInactive
Code: 569DQM74SCClass: IACTQuantity: 1.5 mg in 1 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 0.1 mg in 1 mL

AIMOVIG

Product Details

NDC Product Code
55513-842
Application Number
BLA761077
Marketing Category
BLA (C73585)
Route of Administration
SUBCUTANEOUS
Effective Date
May 16, 2023
ErenumabActive
Code: I5I8VB78VTClass: ACTIBQuantity: 140 mg in 1 mL
ACETATE IONInactive
Code: 569DQM74SCClass: IACTQuantity: 2 mg in 1 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 0.1 mg in 1 mL
SUCROSEInactive
Code: C151H8M554Class: IACTQuantity: 65 mg in 1 mL
© Copyright 2025. All Rights Reserved by MedPath