NDC 71288-018

DAPTOMYCIN

Daptomycin

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

Product ID71288-018_24a6aad9-6faf-4780-b535-9e3998c0b08f
NDC71288-018
Product TypeHuman Prescription Drug
Proprietary NameDAPTOMYCIN
Generic NameDaptomycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-06-26
Marketing End Date2023-09-30
Marketing CategoryANDA / ANDA
Application NumberANDA212513
Labeler NameMeitheal Pharmaceuticals Inc.
Substance NameDAPTOMYCIN
Active Ingredient Strength500 mg/10mL
Pharm ClassesLipopeptide Antibacterial [EPC], Lipopeptides [CS]
NDC Exclude FlagN

Packaging

NDC 71288-018-10

1 VIAL, SINGLE-DOSE in 1 CARTON (71288-018-10) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-06-26
Marketing End Date2023-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71288-018-10 [71288001810]

DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA212513
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-26

Drug Details

Active Ingredients

IngredientStrength
DAPTOMYCIN500 mg/10mL

OpenFDA Data

SPL SET ID:a093a2a2-fbbd-4dac-a6b5-5a32435fa222
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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