MedPath

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

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Levemir - FDA Drug Approval Details