Norditropin
These highlights do not include all the information needed to use Norditropin Cartridges safely and effectively. See full prescribing information for Norditropin Cartridges. Norditropin Cartridges [somatropin (rDNA origin) injection], for subcutaneous useInitial U.S. Approval: 1987
Approved
Approval ID
aa9d3467-a450-4b06-885a-7d834dcbddff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 2, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
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 Code54868-6146
Application NumberNDA021148
Product Classification
M
Marketing Category
C73594
G
Generic Name
somatropin
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 11, 2010
FDA Product Classification
INGREDIENTS (8)
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
HISTIDINEInactive
Quantity: 1 mg in 1.5 mL
Code: 4QD397987E
Classification: IACT
SOMATROPINActive
Quantity: 5 mg in 1.5 mL
Code: NQX9KB6PCL
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
MANNITOLInactive
Quantity: 60 mg in 1.5 mL
Code: 3OWL53L36A
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT