Insulin Glargine
These highlights do not include all the information needed to use INSULIN GLARGINE safely and effectively. See full prescribing information for INSULIN GLARGINE. INSULIN GLARGINE injection, for subcutaneous use Initial U.S. Approval: 2000 This product is LANTUS (insulin glargine).
Approved
Approval ID
406883ea-7f97-4eff-8d43-0bab004654f1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2024
Manufacturers
FDA
Winthrop U.S.
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 Code0955-1728
Application NumberBLA021081
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin glargine
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 3, 2024
FDA Product Classification
INGREDIENTS (7)
INSULIN GLARGINEActive
Quantity: 100 [iU] in 1 mL
Code: 2ZM8CX04RZ
Classification: ACTIB
ZINCInactive
Quantity: 30 ug in 1 mL
Code: J41CSQ7QDS
Classification: IACT
GLYCERINInactive
Quantity: 20 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
METACRESOLInactive
Quantity: 2.7 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
insulin glargine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0955-1729
Application NumberBLA021081
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin glargine
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 3, 2024
FDA Product Classification
INGREDIENTS (8)
INSULIN GLARGINEActive
Quantity: 100 [iU] in 1 mL
Code: 2ZM8CX04RZ
Classification: ACTIB
ZINCInactive
Quantity: 30 ug in 1 mL
Code: J41CSQ7QDS
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 20 ug in 1 mL
Code: 7T1F30V5YH
Classification: IACT
METACRESOLInactive
Quantity: 2.7 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
GLYCERINInactive
Quantity: 20 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT