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
5e1f739a-eb81-43d8-9a14-89f32b7e1ba1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2023
Manufacturers
FDA
Xellia Pharmaceuticals USA LLC
DUNS: 116768762
Products 2
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 Code70594-066
Application NumberNDA217415
Product Classification
M
Marketing Category
C73594
G
Generic Name
daptomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (5)
DAPTOMYCINActive
Quantity: 350 mg in 7 mL
Code: NWQ5N31VKK
Classification: ACTIB
ARGININEInactive
Quantity: 188.1 mg in 7 mL
Code: 94ZLA3W45F
Classification: IACT
ISOLEUCINEInactive
Quantity: 28.3 mg in 7 mL
Code: 04Y7590D77
Classification: IACT
HISTIDINEInactive
Quantity: 100.5 mg in 7 mL
Code: 4QD397987E
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
daptomycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70594-060
Application NumberNDA217415
Product Classification
M
Marketing Category
C73594
G
Generic Name
daptomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (5)
DAPTOMYCINActive
Quantity: 500 mg in 10 mL
Code: NWQ5N31VKK
Classification: ACTIB
HISTIDINEInactive
Quantity: 143.6 mg in 10 mL
Code: 4QD397987E
Classification: IACT
ARGININEInactive
Quantity: 268.7 mg in 10 mL
Code: 94ZLA3W45F
Classification: IACT
ISOLEUCINEInactive
Quantity: 40.5 mg in 10 mL
Code: 04Y7590D77
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT