NDC 70594-053

Daptomycin

Daptomycin

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

Product ID70594-053_0f048116-fbbd-4b91-ae1f-e11abebf0f3e
NDC70594-053
Product TypeHuman Prescription Drug
Proprietary NameDaptomycin
Generic NameDaptomycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-03-15
Marketing CategoryNDA / NDA
Application NumberNDA209949
Labeler NameXellia Pharmaceuticals USA LLC
Substance NameDAPTOMYCIN
Active Ingredient Strength350 mg/7mL
Pharm ClassesLipopeptide Antibacterial [EPC],Lipopeptides [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70594-053-01

1 VIAL, GLASS in 1 CARTON (70594-053-01) > 7 mL in 1 VIAL, GLASS
Marketing Start Date2019-03-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70594-053-01 [70594005301]

Daptomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA209949
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-15

Drug Details

Active Ingredients

IngredientStrength
DAPTOMYCIN350 mg/7mL

OpenFDA Data

SPL SET ID:97c47c18-985d-4373-88f7-a86ec591ea44
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1996246
  • 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

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