Nutropin AQ NuSpin 5
These highlights do not include all the information needed to use Nutropin AQ safely and effectively. See full prescribing information for Nutropin AQ. Nutropin AQ (somatropin) injection, for subcutaneous use Initial U.S. Approval: 1987
Approved
Approval ID
139d2038-e6a9-4ab1-ab00-aa7d8aa8df5f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2021
Manufacturers
FDA
Genentech, Inc.
DUNS: 080129000
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
somatropin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50242-075
Application NumberBLA020522
Product Classification
M
Marketing Category
C73585
G
Generic Name
somatropin
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 22, 2016
FDA Product Classification
INGREDIENTS (5)
SOMATROPINActive
Quantity: 5 mg in 2 mL
Code: NQX9KB6PCL
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 17.4 mg in 2 mL
Code: 451W47IQ8X
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 4 mg in 2 mL
Code: 7T1F30V5YH
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Quantity: 10 mmol in 2 mL
Code: 1Q73Q2JULR
Classification: IACT
PHENOLInactive
Quantity: 5 mg in 2 mL
Code: 339NCG44TV
Classification: IACT
somatropin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50242-076
Application NumberBLA020522
Product Classification
M
Marketing Category
C73585
G
Generic Name
somatropin
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 22, 2016
FDA Product Classification
INGREDIENTS (5)
SOMATROPINActive
Quantity: 20 mg in 2 mL
Code: NQX9KB6PCL
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 17.4 mg in 2 mL
Code: 451W47IQ8X
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 4 mg in 2 mL
Code: 7T1F30V5YH
Classification: IACT
PHENOLInactive
Quantity: 5 mg in 2 mL
Code: 339NCG44TV
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Quantity: 10 mmol in 2 mL
Code: 1Q73Q2JULR
Classification: IACT
somatropin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50242-074
Application NumberBLA020522
Product Classification
M
Marketing Category
C73585
G
Generic Name
somatropin
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 22, 2016
FDA Product Classification
INGREDIENTS (5)
SOMATROPINActive
Quantity: 10 mg in 2 mL
Code: NQX9KB6PCL
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 17.4 mg in 2 mL
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Quantity: 5 mg in 2 mL
Code: 339NCG44TV
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 4 mg in 2 mL
Code: 7T1F30V5YH
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Quantity: 10 mmol in 2 mL
Code: 1Q73Q2JULR
Classification: IACT