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. Initial U.S. Approval: 2003
Approved
Approval ID
6ec53f7e-9a5f-4b24-84e9-c94325750e32
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 14, 2023
Manufacturers
FDA
Hainan Poly Pharm., Co., Ltd.
DUNS: 654561638
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 Code14335-120
Application NumberANDA215890
Product Classification
M
Marketing Category
C73584
G
Generic Name
daptomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 14, 2023
FDA Product Classification
INGREDIENTS (1)
DAPTOMYCINActive
Quantity: 500 mg in 20 mL
Code: NWQ5N31VKK
Classification: ACTIB