NDC 65293-015

Orbactiv

Oritavancin

Orbactiv is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by The Medicines Company. The primary component is Oritavancin.

Product ID65293-015_60ef4da8-d132-f2fe-e053-2a91aa0a4005
NDC65293-015
Product TypeHuman Prescription Drug
Proprietary NameOrbactiv
Generic NameOritavancin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-09-01
Marketing End Date2021-06-30
Marketing CategoryNDA / NDA
Application NumberNDA206334
Labeler NameThe Medicines Company
Substance NameORITAVANCIN
Active Ingredient Strength400 mg/1
Pharm ClassesLipoglycopeptide Antibacterial [EPC],Lipoglycopeptides [EXT],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA]
NDC Exclude FlagN

Packaging

NDC 65293-015-03

3 VIAL, GLASS in 1 CARTON (65293-015-03) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (65293-015-01)
Marketing Start Date2014-09-01
Marketing End Date2021-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65293-015-01 [65293001501]

Orbactiv INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA206334
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-01
Marketing End Date2021-06-30

NDC 65293-015-03 [65293001503]

Orbactiv INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA206334
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-01
Marketing End Date2021-06-30
Inactivation Date2020-01-31
Reactivation Date2020-02-11

Drug Details

Active Ingredients

IngredientStrength
ORITAVANCIN400 mg/1

OpenFDA Data

SPL SET ID:085d6d1a-21c2-11e4-8c21-0800200c9a66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1547620
  • 1547615
  • UPC Code
  • 0365293015019
  • Pharmacological Class

    • Lipoglycopeptide Antibacterial [EPC]
    • Lipoglycopeptides [EXT]
    • Cytochrome P450 2C19 Inhibitors [MoA]
    • Cytochrome P450 2C9 Inhibitors [MoA]
    • Cytochrome P450 3A4 Inducers [MoA]
    • Cytochrome P450 2D6 Inducers [MoA]

    NDC Crossover Matching brand name "Orbactiv" or generic name "Oritavancin"

    NDCBrand NameGeneric Name
    65293-015Orbactivoritavancin
    70842-140Orbactivoritavancin

    Trademark Results [Orbactiv]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ORBACTIV
    ORBACTIV
    86120316 4664703 Live/Registered
    MELINTA THERAPEUTICS, INC.
    2013-11-15

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