Insulin Glargine
These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN. INSULIN GLARGINE-YFGN injection, for subcutaneous useInitial U.S. Approval: 2021
Approved
Approval ID
3ac85ebb-5594-59c8-77fd-df254329d151
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 28, 2023
Manufacturers
FDA
Biocon Biologics Inc.
DUNS: 117609395
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
insulin Glargine-yfgn
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83257-015
Application NumberBLA761201
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin Glargine-yfgn
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 28, 2023
FDA Product Classification
INGREDIENTS (7)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT
ZINC CHLORIDEInactive
Code: 86Q357L16B
Classification: IACT
INSULIN GLARGINEActive
Quantity: 100 [iU] in 1 mL
Code: 2ZM8CX04RZ
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
insulin Glargine-yfgn
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83257-014
Application NumberBLA761201
Product Classification
M
Marketing Category
C73585
G
Generic Name
insulin Glargine-yfgn
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 28, 2023
FDA Product Classification
INGREDIENTS (8)
INSULIN GLARGINEActive
Quantity: 100 [iU] in 1 mL
Code: 2ZM8CX04RZ
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ZINC CHLORIDEInactive
Code: 86Q357L16B
Classification: IACT