Norditropin
These highlights do not include all the information needed to use NORDITROPIN safely and effectively. See full prescribing information for NORDITROPIN. NORDITROPIN (somatropin) injection, for subcutaneous useInitial U.S. Approval: 1987
Approved
Approval ID
1058e17c-9261-459c-a3e6-fae38d196c14
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 9, 2020
Manufacturers
FDA
Novo Nordisk
DUNS: 622920320
Products 4
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 Code0169-7708
Application NumberBLA021148
Product Classification
M
Marketing Category
C73585
G
Generic Name
somatropin
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 9, 2020
FDA Product Classification
INGREDIENTS (8)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SOMATROPINActive
Quantity: 15 mg in 1.5 mL
Code: NQX9KB6PCL
Classification: ACTIB
HISTIDINEInactive
Quantity: 1.7 mg in 1.5 mL
Code: 4QD397987E
Classification: IACT
MANNITOLInactive
Quantity: 58 mg in 1.5 mL
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Quantity: 4.5 mg in 1.5 mL
Code: 339NCG44TV
Classification: IACT
POLOXAMER 188Inactive
Quantity: 4.5 mg in 1.5 mL
Code: LQA7B6G8JG
Classification: IACT
somatropin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-7705
Application NumberBLA021148
Product Classification
M
Marketing Category
C73585
G
Generic Name
somatropin
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 9, 2020
FDA Product Classification
INGREDIENTS (8)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PHENOLInactive
Quantity: 4.5 mg in 1.5 mL
Code: 339NCG44TV
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SOMATROPINActive
Quantity: 10 mg in 1.5 mL
Code: NQX9KB6PCL
Classification: ACTIB
HISTIDINEInactive
Quantity: 1 mg in 1.5 mL
Code: 4QD397987E
Classification: IACT
MANNITOLInactive
Quantity: 60 mg in 1.5 mL
Code: 3OWL53L36A
Classification: IACT
POLOXAMER 188Inactive
Quantity: 4.5 mg in 1.5 mL
Code: LQA7B6G8JG
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
somatropin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-7703
Application NumberBLA021148
Product Classification
M
Marketing Category
C73585
G
Generic Name
somatropin
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 9, 2020
FDA Product Classification
INGREDIENTS (8)
SOMATROPINActive
Quantity: 30 mg in 3 mL
Code: NQX9KB6PCL
Classification: ACTIB
PHENOLInactive
Quantity: 9 mg in 3 mL
Code: 339NCG44TV
Classification: IACT
HISTIDINEInactive
Quantity: 3.3 mg in 3 mL
Code: 4QD397987E
Classification: IACT
POLOXAMER 188Inactive
Quantity: 9 mg in 3 mL
Code: LQA7B6G8JG
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MANNITOLInactive
Quantity: 117 mg in 3 mL
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
somatropin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-7704
Application NumberBLA021148
Product Classification
M
Marketing Category
C73585
G
Generic Name
somatropin
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 9, 2020
FDA Product Classification
INGREDIENTS (8)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SOMATROPINActive
Quantity: 5 mg in 1.5 mL
Code: NQX9KB6PCL
Classification: ACTIB
HISTIDINEInactive
Quantity: 1 mg in 1.5 mL
Code: 4QD397987E
Classification: IACT
MANNITOLInactive
Quantity: 60 mg in 1.5 mL
Code: 3OWL53L36A
Classification: IACT
PHENOLInactive
Quantity: 4.5 mg in 1.5 mL
Code: 339NCG44TV
Classification: IACT
POLOXAMER 188Inactive
Quantity: 4.5 mg in 1.5 mL
Code: LQA7B6G8JG
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT