NDC 52584-240

Phytonadione

Phytonadione

Phytonadione is a Parenteral Injection, Emulsion in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Phytonadione.

Product ID52584-240_19c78682-1798-4ce4-a251-e5bdc57821df
NDC52584-240
Product TypeHuman Prescription Drug
Proprietary NamePhytonadione
Generic NamePhytonadione
Dosage FormInjection, Emulsion
Route of AdministrationPARENTERAL
Marketing Start Date2012-09-14
Marketing CategoryANDA / ANDA
Application NumberANDA083722
Labeler NameGeneral Injectables & Vaccines, Inc
Substance NamePHYTONADIONE
Active Ingredient Strength1 mg/.5mL
Pharm ClassesIncreased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [CS],Vitamin K [EPC],Warfarin Reversal Agent [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC SPL Data Element Entries

NDC 52584-240-00 [52584024000]

Phytonadione INJECTION, EMULSION
Marketing CategoryANDA
Application NumberANDA083722
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-09-14
Marketing End Date2013-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PHYTONADIONE1 mg/.5mL

OpenFDA Data

SPL SET ID:c89a776d-7886-42fe-afcb-5842eb893c23
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 727625
  • 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 "Phytonadione" or generic name "Phytonadione"

    NDCBrand NameGeneric Name
    0404-9935PHYTONADIONEphytonadione
    0404-9969PHYTONADIONEphytonadione
    0904-6882PhytonadionePhytonadione
    16714-973PhytonadionePhytonadione
    43598-405PHYTONADIONEPHYTONADIONE
    50268-661Phytonadionephytonadione
    52565-142Phytonadionephytonadione
    52565-143PhytonadionePHYTONADIONE
    52584-043PHYTONADIONEphytonadione
    52584-046PHYTONADIONEphytonadione
    68682-170PhytonadionePhytonadione
    69238-1051PhytonadionePhytonadione
    70710-1014PhytonadionePhytonadione
    70771-1318PhytonadionePhytonadione
    76329-1240PhytonadionePhytonadione
    52584-240PhytonadionePhytonadione
    60687-381PhytonadionePhytonadione
    52584-405PHYTONADIONEPHYTONADIONE
    52565-092AquaMEPHYTONphytonadione
    52565-093AquaMEPHYTONPHYTONADIONE
    0187-1704Mephytonphytonadione
    21695-168MEPHYTONphytonadione
    50090-1753Mephytonphytonadione
    0409-9157Vitamin K1PHYTONADIONE
    0409-9158Vitamin K1PHYTONADIONE
    50090-4521Vitamin K1PHYTONADIONE
    50090-4523Vitamin K1PHYTONADIONE

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