SOGROYA
These highlights do not include all the information needed to use SOGROYA safely and effectively. See full prescribing information for SOGROYA.SOGROYA (somapacitan-beco) injection, for subcutaneous useInitial U.S. Approval: 2020
Approved
Approval ID
eadd03b4-adc3-4b88-8a24-9d205c5b85aa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2023
Manufacturers
FDA
Novo Nordisk
DUNS: 622920320
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
somapacitan-beco
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-2035
Application NumberBLA761156
Product Classification
M
Marketing Category
C73585
G
Generic Name
somapacitan-beco
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateApril 28, 2023
FDA Product Classification
INGREDIENTS (8)
SOMAPACITANActive
Quantity: 3.3 mg in 1 mL
Code: 8FOJ430U94
Classification: ACTIB
HISTIDINEInactive
Quantity: 0.68 mg in 1 mL
Code: 4QD397987E
Classification: IACT
MANNITOLInactive
Quantity: 44 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
PHENOLInactive
Quantity: 4 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
POLOXAMER 188Inactive
Quantity: 1 mg in 1 mL
Code: LQA7B6G8JG
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
somapacitan-beco
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-2037
Application NumberBLA761156
Product Classification
M
Marketing Category
C73585
G
Generic Name
somapacitan-beco
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateApril 28, 2023
FDA Product Classification
INGREDIENTS (8)
SOMAPACITANActive
Quantity: 10 mg in 1 mL
Code: 8FOJ430U94
Classification: ACTIB
HISTIDINEInactive
Quantity: 0.68 mg in 1 mL
Code: 4QD397987E
Classification: IACT
MANNITOLInactive
Quantity: 44 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
POLOXAMER 188Inactive
Quantity: 1 mg in 1 mL
Code: LQA7B6G8JG
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM
PHENOLInactive
Quantity: 4 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
somapacitan-beco
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-2030
Application NumberBLA761156
Product Classification
M
Marketing Category
C73585
G
Generic Name
somapacitan-beco
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateApril 28, 2023
FDA Product Classification
INGREDIENTS (8)
HISTIDINEInactive
Quantity: 0.68 mg in 1 mL
Code: 4QD397987E
Classification: IACT
SOMAPACITANActive
Quantity: 6.7 mg in 1 mL
Code: 8FOJ430U94
Classification: ACTIB
MANNITOLInactive
Quantity: 44 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM
PHENOLInactive
Quantity: 4 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
POLOXAMER 188Inactive
Quantity: 1 mg in 1 mL
Code: LQA7B6G8JG
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM