Cubicin
These highlights do not include all the information needed to use CUBICIN safely and effectively. See full prescribing information for CUBICIN. CUBICIN (daptomycin for injection), for Intravenous UseInitial U.S. Approval: 2003
Approved
Approval ID
a7975871-46a6-4e9b-a8b5-38bfcb465f0e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 2023
Manufacturers
FDA
Merck Sharp & Dohme LLC
DUNS: 118446553
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Daptomycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67919-011
Application NumberNDA021572
Product Classification
M
Marketing Category
C73594
G
Generic Name
Daptomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 22, 2022
FDA Product Classification
INGREDIENTS (2)
DaptomycinActive
Quantity: 500 mg in 10 mL
Code: NWQ5N31VKK
Classification: ACTIB
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT