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
NDC Product Code54868-5883
Application NumberNDA021536
Marketing CategoryC73594
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 2, 2012
Generic Nameinsulin detemir
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