EMGALITY
These highlights do not include all the information needed to use EMGALITY safely and effectively. See full prescribing information for EMGALITY.EMGALITY (galcanezumab-gnlm) injection, for subcutaneous useInitial U.S. Approval: 2018
Approved
Approval ID
33a147be-233a-40e8-a55e-e40936e28db0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 11, 2021
Manufacturers
FDA
Eli Lilly and Company
DUNS: 006421325
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
galcanezumab-gnlm
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0002-3115
Application NumberBLA761063
Product Classification
M
Marketing Category
C73585
G
Generic Name
galcanezumab-gnlm
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateSeptember 28, 2020
FDA Product Classification
INGREDIENTS (6)
galcanezumabActive
Quantity: 100 mg in 1 mL
Code: 55KHL3P693
Classification: ACTIB
HistidineInactive
Quantity: 0.5 mg in 1 mL
Code: 4QD397987E
Classification: IACT
Histidine Monohydrochloride MonohydrateInactive
Quantity: 1.5 mg in 1 mL
Code: X573657P6P
Classification: IACT
Sodium ChlorideInactive
Quantity: 8.8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Polysorbate 80Inactive
Quantity: 0.5 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
galcanezumab-gnlm
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0002-2377
Application NumberBLA761063
Product Classification
M
Marketing Category
C73585
G
Generic Name
galcanezumab-gnlm
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateSeptember 28, 2020
FDA Product Classification
INGREDIENTS (6)
Polysorbate 80Inactive
Quantity: 0.5 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
Histidine Monohydrochloride MonohydrateInactive
Quantity: 1.5 mg in 1 mL
Code: X573657P6P
Classification: IACT
galcanezumabActive
Quantity: 120 mg in 1 mL
Code: 55KHL3P693
Classification: ACTIB
HistidineInactive
Quantity: 0.5 mg in 1 mL
Code: 4QD397987E
Classification: IACT
Sodium ChlorideInactive
Quantity: 8.8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
galcanezumab-gnlm
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0002-1436
Application NumberBLA761063
Product Classification
M
Marketing Category
C73585
G
Generic Name
galcanezumab-gnlm
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateSeptember 28, 2020
FDA Product Classification
INGREDIENTS (6)
galcanezumabActive
Quantity: 120 mg in 1 mL
Code: 55KHL3P693
Classification: ACTIB
HistidineInactive
Quantity: 0.5 mg in 1 mL
Code: 4QD397987E
Classification: IACT
Sodium ChlorideInactive
Quantity: 8.8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
Histidine Monohydrochloride MonohydrateInactive
Quantity: 1.5 mg in 1 mL
Code: X573657P6P
Classification: IACT
Polysorbate 80Inactive
Quantity: 0.5 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT