Omnitrope
These highlights do not include all the information needed to use OMNITROPE® safely and effectively. See full prescribing information for OMNITROPE®.OMNITROPE® (somatropin) injection, for subcutaneous useInitial U.S. Approval: 1987
Approved
Approval ID
58d84ffa-4056-4e36-ad67-7bd4aef444a5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 18, 2019
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
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 Code0781-3001
Application NumberBLA021426
Product Classification
M
Marketing Category
C73585
G
Generic Name
Somatropin
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJune 18, 2019
FDA Product Classification
INGREDIENTS (7)
SOMATROPINActive
Quantity: 5 mg in 1.5 mL
Code: NQX9KB6PCL
Classification: ACTIB
BENZYL ALCOHOLInactive
Quantity: 13.5 mg in 1.5 mL
Code: LKG8494WBH
Classification: IACT
MANNITOLInactive
Quantity: 52.5 mg in 1.5 mL
Code: 3OWL53L36A
Classification: IACT
POLOXAMER 188Inactive
Quantity: 3 mg in 1.5 mL
Code: LQA7B6G8JG
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Quantity: 1.15 mg in 1.5 mL
Code: 70WT22SF4B
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Quantity: 1.67 mg in 1.5 mL
Code: 5QWK665956
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Somatropin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-3004
Application NumberBLA021426
Product Classification
M
Marketing Category
C73585
G
Generic Name
Somatropin
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJune 18, 2019
FDA Product Classification
INGREDIENTS (7)
SOMATROPINActive
Quantity: 10 mg in 1.5 mL
Code: NQX9KB6PCL
Classification: ACTIB
PHENOLInactive
Quantity: 4.5 mg in 1.5 mL
Code: 339NCG44TV
Classification: IACT
GLYCINEInactive
Quantity: 27.75 mg in 1.5 mL
Code: TE7660XO1C
Classification: IACT
POLOXAMER 188Inactive
Quantity: 3 mg in 1.5 mL
Code: LQA7B6G8JG
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Quantity: 1.34 mg in 1.5 mL
Code: 70WT22SF4B
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Quantity: 1.56 mg in 1.5 mL
Code: 5QWK665956
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Somatropin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-4004
Application NumberBLA021426
Product Classification
M
Marketing Category
C73585
G
Generic Name
Somatropin
Product Specifications
Effective DateJune 18, 2019
FDA Product Classification