NDC 70842-102

Baxdela

Delafloxacin Meglumine

Baxdela is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Melinta Therapeutics, Llc. The primary component is Delafloxacin Meglumine.

Product ID70842-102_1fbc1d58-acc9-496d-b4b1-898da783df93
NDC70842-102
Product TypeHuman Prescription Drug
Proprietary NameBaxdela
Generic NameDelafloxacin Meglumine
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-06-19
Marketing CategoryNDA / NDA
Application NumberNDA208611
Labeler NameMelinta Therapeutics, LLC
Substance NameDELAFLOXACIN MEGLUMINE
Active Ingredient Strength300 mg/10.5mL
Pharm ClassesFluoroquinolone Antibacterial [EPC],Fluoroquinolones [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 70842-102-03

10 VIAL, GLASS in 1 CARTON (70842-102-03) > 10.5 mL in 1 VIAL, GLASS (70842-102-01)
Marketing Start Date2017-06-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70842-102-03 [70842010203]

Baxdela INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA208611
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-19

NDC 70842-102-01 [70842010201]

Baxdela INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA208611
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-09

Drug Details

Active Ingredients

IngredientStrength
DELAFLOXACIN MEGLUMINE300 mg/10.5mL

OpenFDA Data

SPL SET ID:fb77637a-88d9-4aea-958f-e270030ce30d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1927667
  • 1927682
  • 1927672
  • 1927677
  • Pharmacological Class

    • Fluoroquinolone Antibacterial [EPC]
    • Fluoroquinolones [CS]

    NDC Crossover Matching brand name "Baxdela" or generic name "Delafloxacin Meglumine"

    NDCBrand NameGeneric Name
    70842-101Baxdeladelafloxacin meglumine
    70842-102Baxdeladelafloxacin meglumine

    Trademark Results [Baxdela]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BAXDELA
    BAXDELA
    88058147 5725767 Live/Registered
    Melinta Subsidiary Corp.
    2018-07-30
    BAXDELA
    BAXDELA
    86707152 5561401 Live/Registered
    MELINTA SUBSIDIARY CORP.
    2015-07-28

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