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 useInitial U.S. Approval: 2003
Approved
Approval ID
4a0ad110-e55e-4d3b-84f8-dd0b924fe2f6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 17, 2022
Manufacturers
FDA
Sagent Pharmaceuticals
DUNS: 080579617
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Daptomycin
PRODUCT DETAILS
NDC Product Code25021-179
Application NumberNDA208385
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJune 17, 2022
Generic NameDaptomycin
INGREDIENTS (2)
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
DaptomycinActive
Quantity: 350 mg in 7 mL
Code: NWQ5N31VKK
Classification: ACTIB