MedPath

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

b1569dbe-7876-481e-bc1c-9c9dd85c4973

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 13, 2023

Manufacturers
FDA

Civica, Inc.

DUNS: 081373942

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 Code72572-102
Application NumberANDA206005
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateNovember 13, 2023
Generic NameDaptomycin

INGREDIENTS (2)

DAPTOMYCINActive
Quantity: 500 mg in 10 mL
Code: NWQ5N31VKK
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Daptomycin - FDA Drug Approval Details