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
97c47c18-985d-4373-88f7-a86ec591ea44
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2023
Manufacturers
FDA
Xellia Pharmaceuticals USA LLC
DUNS: 116768762
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 Code70594-053
Application NumberNDA209949
Product Classification
M
Marketing Category
C73594
G
Generic Name
Daptomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 11, 2023
FDA Product Classification
INGREDIENTS (2)
DAPTOMYCINActive
Quantity: 350 mg in 7 mL
Code: NWQ5N31VKK
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT