Levemir
Levemir (insulin detemir [rDNA origin] injection)
Approved
Approval ID
2b8d9730-686b-444b-9941-7b5877255924
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 2011
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
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 Code68258-8977
Application NumberNDA021536
Product Classification
M
Marketing Category
C73594
G
Generic Name
insulin detemir
Product Specifications
Route of AdministrationSOFT TISSUE
Effective DateSeptember 14, 2011
FDA Product Classification
INGREDIENTS (9)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
GLYCERINInactive
Quantity: 16 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
INSULIN DETEMIRActive
Quantity: 14.2 mg in 1 mL
Code: 4FT78T86XV
Classification: ACTIB
METACRESOLInactive
Quantity: 2.06 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 1.17 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Quantity: 1.8 mg in 1 mL
Code: 339NCG44TV
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