NDC 67457-813

daptomycin

Daptomycin

daptomycin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Daptomycin.

Product ID67457-813_12984edc-7aa5-4fd9-8c30-249a9f5f5350
NDC67457-813
Product TypeHuman Prescription Drug
Proprietary Namedaptomycin
Generic NameDaptomycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-09-04
Marketing CategoryANDA / ANDA
Application NumberANDA205037
Labeler NameMylan Institutional LLC
Substance NameDAPTOMYCIN
Active Ingredient Strength500 mg/10mL
Pharm ClassesLipopeptide Antibacterial [EPC],Lipopeptides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 67457-813-50

1 VIAL, SINGLE-DOSE in 1 CARTON (67457-813-50) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-09-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-813-50 [67457081350]

daptomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA205037
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-09-04

Drug Details

Active Ingredients

IngredientStrength
DAPTOMYCIN500 mg/10mL

OpenFDA Data

SPL SET ID:b7737862-e783-4af3-9521-ae00ed7a42aa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403920
  • Pharmacological Class

    • 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

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