NDC 0703-0125

Daptomycin

Daptomycin

Daptomycin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Teva Parenteral Medicines, Inc.. The primary component is Daptomycin.

Product ID0703-0125_1049d724-0edd-4b58-83ce-043978d28d38
NDC0703-0125
Product TypeHuman Prescription Drug
Proprietary NameDaptomycin
Generic NameDaptomycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-09-14
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021572
Labeler NameTeva Parenteral Medicines, Inc.
Substance NameDAPTOMYCIN
Active Ingredient Strength500 mg/10mL
Pharm ClassesLipopeptide Antibacterial [EPC],Lipopeptides [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0703-0125-01

1 VIAL, SINGLE-USE in 1 CARTON (0703-0125-01) > 10 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2016-09-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0703-0125-01 [00703012501]

Daptomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA021572
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-15

Drug Details

Active Ingredients

IngredientStrength
DAPTOMYCIN500 mg/10mL

OpenFDA Data

SPL SET ID:9f5be30b-7f70-4533-b92e-8c15f007b2a4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403920
  • Pharmacological Class

    • Lipopeptide Antibacterial [EPC]
    • Lipopeptides [CS]
    • Lipopeptide Antibacterial [EPC]
    • Lipopeptides [CS]

    NDC Crossover Matching brand name "Daptomycin" or generic name "Daptomycin"

    NDCBrand NameGeneric Name
    0143-9378DaptomycinDaptomycin
    0409-0106DaptomycinDAPTOMYCIN
    0409-0120DaptomycinDAPTOMYCIN
    0409-0122DaptomycinDAPTOMYCIN
    0409-2757DaptomycinDAPTOMYCIN
    0409-5933DaptomycinDaptomycin
    0703-0125DaptomycinDaptomycin
    0781-3295daptomycindaptomycin
    16714-892DaptomycinDaptomycin
    16729-434DaptomycinDaptomycin
    16729-435DAPTOMYCINDaptomycin
    25021-174daptomycindaptomycin
    25021-179DaptomycinDaptomycin
    70594-034DaptomycinDaptomycin
    70594-053DaptomycinDaptomycin
    63323-871DaptomycinDaptomycin
    63323-371DaptomycinDaptomycin
    67457-813daptomycindaptomycin
    43598-413DaptomycinDaptomycin
    68001-376DaptomycinDaptomycin
    63323-585DaptomycinDaptomycin
    71839-107daptomycindaptomycin
    57884-3151DaptomycinDaptomycin
    69097-807DaptomycinDaptomycin
    72572-102DaptomycinDaptomycin
    72572-100DaptomycinDaptomycin
    45932-0039DaptomycinDaptomycin
    71288-018DAPTOMYCINDAPTOMYCIN
    76233-091DaptomycinDaptomycin
    31722-102DaptomycinDaptomycin

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.