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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

bcacf746-a3ee-48b5-bfbe-6a2b548ad24c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 12, 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 Code72572-100
Application NumberNDA209949
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateOctober 12, 2023
Generic NameDaptomycin

INGREDIENTS (2)

DAPTOMYCINActive
Quantity: 350 mg in 7 mL
Code: NWQ5N31VKK
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

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Daptomycin - FDA Drug Approval Details