Insulin Degludec
These highlights do not include all the information needed to use INSULIN DEGLUDEC safely and effectively. See full prescribing information for INSULIN DEGLUDEC. INSULIN DEGLUDEC injection, for subcutaneous useInitial U.S. Approval: 2015
Approved
Approval ID
c1be283d-4b1d-4996-b2a7-4488dbff3037
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2022
Manufacturers
FDA
Novo Nordisk Pharma, Inc.
DUNS: 117032563
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
insulin degludec
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73070-503
Application NumberBLA203314
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin degludec
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 1, 2022
FDA Product Classification
INGREDIENTS (8)
ZINCInactive
Quantity: 71.9 ug in 1 mL
Code: J41CSQ7QDS
Classification: IACT
INSULIN DEGLUDECActive
Quantity: 200 U in 1 mL
Code: 54Q18076QB
Classification: ACTIB
PHENOLInactive
Quantity: 1.50 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Quantity: 19.6 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
METACRESOLInactive
Quantity: 1.72 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
insulin degludec
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73070-403
Application NumberBLA203314
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin degludec
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 1, 2022
FDA Product Classification
INGREDIENTS (8)
INSULIN DEGLUDECActive
Quantity: 100 U in 1 mL
Code: 54Q18076QB
Classification: ACTIB
PHENOLInactive
Quantity: 1.50 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Quantity: 19.6 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
ZINCInactive
Quantity: 32.7 ug in 1 mL
Code: J41CSQ7QDS
Classification: IACT
METACRESOLInactive
Quantity: 1.72 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
insulin degludec
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73070-400
Application NumberBLA203314
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin degludec
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 1, 2022
FDA Product Classification
INGREDIENTS (8)
INSULIN DEGLUDECActive
Quantity: 100 U in 1 mL
Code: 54Q18076QB
Classification: ACTIB
PHENOLInactive
Quantity: 1.50 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
METACRESOLInactive
Quantity: 1.72 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
ZINCInactive
Quantity: 32.7 ug in 1 mL
Code: J41CSQ7QDS
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GLYCERINInactive
Quantity: 19.6 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT