NDC 16729-435

DAPTOMYCIN

Daptomycin

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

Product ID16729-435_8c2055b8-c416-6e86-e053-2a95a90a284c
NDC16729-435
Product TypeHuman Prescription Drug
Proprietary NameDAPTOMYCIN
Generic NameDaptomycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-06-24
Marketing CategoryANDA / ANDA
Application NumberANDA211961
Labeler NameAccord Healthcare Inc.
Substance NameDAPTOMYCIN
Active Ingredient Strength500 mg/10mL
Pharm ClassesLipopeptide Antibacterial [EPC],Lipopeptides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 16729-435-05

1 VIAL, SINGLE-DOSE in 1 CARTON (16729-435-05) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-06-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16729-435-05 [16729043505]

DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA211961
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-24

Drug Details

Active Ingredients

IngredientStrength
DAPTOMYCIN500 mg/10mL

OpenFDA Data

SPL SET ID:956b068f-5958-49eb-9c9f-3b6e324e77d2
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

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