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AIMOVIG

These highlights do not include all the information needed to use AIMOVIG safely and effectively. See full prescribing information for AIMOVIG. AIMOVIG (erenumab-aooe) injection, for subcutaneous use Initial U.S. Approval: 2018

Approved
Approval ID

b998ed05-94b0-47fd-b28f-cddd1e128fd8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 16, 2023

Manufacturers
FDA

Amgen Inc

DUNS: 039976196

Products 4

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

erenumab-aooe

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55513-841
Application NumberBLA761077
Product Classification
M
Marketing Category
C73585
G
Generic Name
erenumab-aooe
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMay 16, 2023
FDA Product Classification

INGREDIENTS (4)

ERENUMABActive
Quantity: 70 mg in 1 mL
Code: I5I8VB78VT
Classification: ACTIB
ACETATE IONInactive
Quantity: 1.5 mg in 1 mL
Code: 569DQM74SC
Classification: IACT
SUCROSEInactive
Quantity: 73 mg in 1 mL
Code: C151H8M554
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.1 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT

erenumab-aooe

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55513-843
Application NumberBLA761077
Product Classification
M
Marketing Category
C73585
G
Generic Name
erenumab-aooe
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMay 16, 2023
FDA Product Classification

INGREDIENTS (4)

ERENUMABActive
Quantity: 140 mg in 1 mL
Code: I5I8VB78VT
Classification: ACTIB
SUCROSEInactive
Quantity: 65 mg in 1 mL
Code: C151H8M554
Classification: IACT
ACETATE IONInactive
Quantity: 2 mg in 1 mL
Code: 569DQM74SC
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.1 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT

erenumab-aooe

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55513-840
Application NumberBLA761077
Product Classification
M
Marketing Category
C73585
G
Generic Name
erenumab-aooe
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMay 16, 2023
FDA Product Classification

INGREDIENTS (4)

SUCROSEInactive
Quantity: 73 mg in 1 mL
Code: C151H8M554
Classification: IACT
ERENUMABActive
Quantity: 70 mg in 1 mL
Code: I5I8VB78VT
Classification: ACTIB
ACETATE IONInactive
Quantity: 1.5 mg in 1 mL
Code: 569DQM74SC
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.1 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT

erenumab-aooe

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55513-842
Application NumberBLA761077
Product Classification
M
Marketing Category
C73585
G
Generic Name
erenumab-aooe
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMay 16, 2023
FDA Product Classification

INGREDIENTS (4)

ERENUMABActive
Quantity: 140 mg in 1 mL
Code: I5I8VB78VT
Classification: ACTIB
ACETATE IONInactive
Quantity: 2 mg in 1 mL
Code: 569DQM74SC
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.1 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
SUCROSEInactive
Quantity: 65 mg in 1 mL
Code: C151H8M554
Classification: IACT

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