Levemir
These highlights do not include all the information needed to use LEVEMIR safely and effectively.See full prescribing information for LEVEMIR. LEVEMIR (insulin detemir) injection, for subcutaneous useInitial U.S. Approval: 2005
Approved
Approval ID
82192527-99aa-4b53-8ce9-9173668d309c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 13, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
insulin detemir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-1276
Application NumberBLA021536
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin detemir
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 8, 2022
FDA Product Classification
INGREDIENTS (9)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
INSULIN DETEMIRActive
Quantity: 100 [iU] in 1 mL
Code: 4FT78T86XV
Classification: ACTIB
PHENOLInactive
Quantity: 1.8 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 1.17 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 0.89 mg in 1 mL
Code: 94255I6E2T
Classification: IACT
GLYCERINInactive
Quantity: 16 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
METACRESOLInactive
Quantity: 2.06 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ZINCInactive
Quantity: 65.4 ug in 1 mL
Code: J41CSQ7QDS
Classification: IACT
insulin detemir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-1475
Application NumberBLA021536
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin detemir
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 8, 2022
FDA Product Classification
INGREDIENTS (10)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ZINCInactive
Code: J41CSQ7QDS
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
INSULIN DETEMIRActive
Quantity: 100 [iU] in 1 mL
Code: 4FT78T86XV
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT