Lantus
These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injectionInitial U.S. Approval: 2000
Approved
Approval ID
f2149727-c2df-41b0-97f1-45ea75e0aa1a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 20, 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 glargine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55045-3685
Application NumberNDA021081
Product Classification
M
Marketing Category
C73594
G
Generic Name
insulin glargine
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateSeptember 20, 2011
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