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
d87bd6b5-bf92-49c1-879b-dc2add3deae6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2024
Manufacturers
FDA
MAIA Pharmaceuticals, Inc.
DUNS: 079211845
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 Code70511-181
Application NumberNDA217630
Product Classification
M
Marketing Category
C73594
G
Generic Name
Daptomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 4, 2024
FDA Product Classification
INGREDIENTS (4)
DAPTOMYCINActive
Quantity: 350 mg in 1 1
Code: NWQ5N31VKK
Classification: ACTIB
ARGININE HYDROCHLORIDEInactive
Quantity: 210 mg in 1 1
Code: F7LTH1E20Y
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Daptomycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70511-182
Application NumberNDA217630
Product Classification
M
Marketing Category
C73594
G
Generic Name
Daptomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 4, 2024
FDA Product Classification
INGREDIENTS (4)
ARGININE HYDROCHLORIDEInactive
Quantity: 300 mg in 1 1
Code: F7LTH1E20Y
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
DAPTOMYCINActive
Quantity: 500 mg in 1 1
Code: NWQ5N31VKK
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT