NDC 52565-093

AquaMEPHYTON

Phytonadione

AquaMEPHYTON is a Intramuscular; Intravenous; Subcutaneous Injection, Emulsion in the Human Prescription Drug category. It is labeled and distributed by Teligent Pharma, Inc.. The primary component is Phytonadione.

Product ID52565-093_2eb2025f-7602-4f3c-be99-547033e04ad7
NDC52565-093
Product TypeHuman Prescription Drug
Proprietary NameAquaMEPHYTON
Generic NamePhytonadione
Dosage FormInjection, Emulsion
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2018-03-07
Marketing CategoryNDA / NDA
Application NumberNDA012223
Labeler NameTeligent Pharma, Inc.
Substance NamePHYTONADIONE
Active Ingredient Strength10 mg/mL
Pharm ClassesIncreased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [CS],Vitamin K [EPC],Warfarin Reversal Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52565-093-05

5 AMPULE in 1 TRAY (52565-093-05) > 1 mL in 1 AMPULE
Marketing Start Date2018-03-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52565-093-01 [52565009301]

AquaMEPHYTON INJECTION, EMULSION
Marketing CategoryNDA
Application NumberNDA012223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-25
Marketing End Date2019-02-22

NDC 52565-093-05 [52565009305]

AquaMEPHYTON INJECTION, EMULSION
Marketing CategoryNDA
Application NumberNDA012223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-07
Marketing End Date2019-10-17

Drug Details

Active Ingredients

IngredientStrength
PHYTONADIONE10 mg/mL

OpenFDA Data

SPL SET ID:202757c7-caf6-44f5-9701-b89e4871df59
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1923617
  • 1670192
  • 1923622
  • 312424
  • Pharmacological Class

    • Increased Prothrombin Activity [PE]
    • Reversed Anticoagulation Activity [PE]
    • Vitamin K [CS]
    • Vitamin K [EPC]
    • Warfarin Reversal Agent [EPC]

    NDC Crossover Matching brand name "AquaMEPHYTON" or generic name "Phytonadione"

    NDCBrand NameGeneric Name
    52565-092AquaMEPHYTONphytonadione
    52565-093AquaMEPHYTONPHYTONADIONE
    0187-1704Mephytonphytonadione
    21695-168MEPHYTONphytonadione
    50090-1753Mephytonphytonadione
    0404-9935PHYTONADIONEphytonadione
    0404-9969PHYTONADIONEphytonadione
    0904-6882PhytonadionePhytonadione
    16714-973PhytonadionePhytonadione
    43598-405PHYTONADIONEPHYTONADIONE
    50268-661Phytonadionephytonadione
    52565-142Phytonadionephytonadione
    52565-143PhytonadionePHYTONADIONE
    52584-043PHYTONADIONEphytonadione
    52584-046PHYTONADIONEphytonadione
    0409-9157Vitamin K1PHYTONADIONE
    0409-9158Vitamin K1PHYTONADIONE
    50090-4521Vitamin K1PHYTONADIONE
    50090-4523Vitamin K1PHYTONADIONE

    Trademark Results [AquaMEPHYTON]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AQUAMEPHYTON
    AQUAMEPHYTON
    87924986 not registered Dead/Abandoned
    Teligent, Inc.
    2018-05-17
    AQUAMEPHYTON
    AQUAMEPHYTON
    86494924 not registered Dead/Abandoned
    TELIGENT, INC.
    2015-01-05
    AQUAMEPHYTON
    AQUAMEPHYTON
    85051622 not registered Dead/Abandoned
    Aton Pharma, Inc
    2010-06-01
    AQUAMEPHYTON
    AQUAMEPHYTON
    72071135 0689024 Dead/Expired
    MERCK & CO., INC.
    1959-04-08

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