Daptomycin
These highlights do not include all the information needed to use DAPTOMYCIN FOR INJECTION safely and effectively. See full prescribing information for DAPTOMYCIN FOR INJECTION. DAPTOMYCIN for injection, for Intravenous Use Initial U.S. Approval: 2003
Approved
Approval ID
e6fef9de-e357-4fa3-8839-f483edf1b4d0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 5, 2023
Manufacturers
FDA
Aspiro Pharma Limited
DUNS: 872341023
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 Code72201-1009
Application NumberANDA216413
Product Classification
M
Marketing Category
C73584
G
Generic Name
Daptomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 5, 2023
FDA Product Classification
INGREDIENTS (2)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
DAPTOMYCINActive
Quantity: 500 mg in 10 mL
Code: NWQ5N31VKK
Classification: ACTIB