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
e32c7141-fbd9-47c8-bd1e-94b880b2c5a6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2021
Manufacturers
FDA
Qilu Pharmaceutical Co., Ltd.
DUNS: 653878256
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 Code67184-0549
Application NumberANDA215316
Product Classification
M
Marketing Category
C73584
G
Generic Name
Daptomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 17, 2021
FDA Product Classification
INGREDIENTS (2)
DaptomycinActive
Quantity: 500 mg in 10 mL
Code: NWQ5N31VKK
Classification: ACTIB
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT