NDC 52584-405

PHYTONADIONE

Phytonadione

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

Product ID52584-405_0c5cfa9f-d9ef-4994-a46c-89d15224cca5
NDC52584-405
Product TypeHuman Prescription Drug
Proprietary NamePHYTONADIONE
Generic NamePhytonadione
Dosage FormInjection, Emulsion
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2019-08-20
Marketing CategoryANDA / ANDA
Application NumberANDA207719
Labeler NameGeneral Injectables & Vaccines, 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 Through2022-12-31

Packaging

NDC 52584-405-11

1 AMPULE in 1 BAG (52584-405-11) > 1 mL in 1 AMPULE
Marketing Start Date2019-08-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-405-11 [52584040511]

PHYTONADIONE INJECTION, EMULSION
Marketing CategoryANDA
Application NumberANDA207719
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-20

Drug Details

Active Ingredients

IngredientStrength
PHYTONADIONE10 mg/mL

OpenFDA Data

SPL SET ID:902eb3ff-4b34-4b2b-9a64-7f206ebfed90
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1670192
  • 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
    52584-240PhytonadionePhytonadione
    52584-405PHYTONADIONEphytonadione
    68682-170PhytonadionePhytonadione
    69238-1051PhytonadionePhytonadione
    70710-1014PhytonadionePhytonadione
    70771-1318PhytonadionePhytonadione
    76329-1240PhytonadionePhytonadione
    60687-381PhytonadionePhytonadione
    52565-092AquaMEPHYTONphytonadione
    52565-093AquaMEPHYTONPHYTONADIONE
    0187-1704Mephytonphytonadione
    21695-168MEPHYTONphytonadione
    50090-1753Mephytonphytonadione
    0409-9157Vitamin K1PHYTONADIONE
    0409-9158Vitamin K1PHYTONADIONE
    50090-4521Vitamin K1PHYTONADIONE
    50090-4523Vitamin K1PHYTONADIONE
    52584-158Vitamin K1Phytonadione

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