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 [rDNA origin] injection) solution for subcutaneous injectionInitial U.S. Approval: 2005
Approved
Approval ID
eae6fcac-02a9-4d7c-8445-03a647b6b59b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 2, 2012
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.
insulin detemir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5883
Application NumberNDA021536
Product Classification
M
Marketing Category
C73594
G
Generic Name
insulin detemir
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 2, 2012
FDA Product Classification
INGREDIENTS (9)
INSULIN DETEMIRActive
Quantity: 14.2 mg in 1 mL
Code: 4FT78T86XV
Classification: ACTIB
GLYCERINInactive
Quantity: 16.0 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
METACRESOLInactive
Quantity: 2.06 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
PHENOLInactive
Quantity: 1.80 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 1.17 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 0.89 mg in 1 mL
Code: 94255I6E2T
Classification: IACT
ZINCInactive
Quantity: 65.4 ug in 1 mL
Code: J41CSQ7QDS
Classification: IACT