Insulin glargine U-300
These highlights do not include all the information needed to use INSULIN GLARGINE U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE U-300. INSULIN GLARGINE U-300 (insulin glargine) injection, for subcutaneous use Initial U.S. Approval: 2015
Approved
Approval ID
99ea856d-9562-443a-9422-1006a3cff2f4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2023
Manufacturers
FDA
Winthrop U.S, a business of sanofi-aventis U.S. LLC
DUNS: 824676584
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
insulin glargine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0955-2900
Application NumberBLA206538
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin glargine
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 7, 2023
FDA Product Classification
INGREDIENTS (7)
METACRESOLInactive
Quantity: 2.7 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
ZINCInactive
Quantity: 90 ug in 1 mL
Code: J41CSQ7QDS
Classification: IACT
GLYCERINInactive
Quantity: 20 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
INSULIN GLARGINEActive
Quantity: 300 [iU] in 1 mL
Code: 2ZM8CX04RZ
Classification: ACTIB
insulin glargine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0955-3900
Application NumberBLA206538
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin glargine
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 7, 2023
FDA Product Classification
INGREDIENTS (7)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GLYCERINInactive
Quantity: 20 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
INSULIN GLARGINEActive
Quantity: 300 [iU] in 1 mL
Code: 2ZM8CX04RZ
Classification: ACTIB
ZINCInactive
Quantity: 90 ug in 1 mL
Code: J41CSQ7QDS
Classification: IACT
METACRESOLInactive
Quantity: 2.7 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT