NDC 69238-1051

Phytonadione

Phytonadione

Phytonadione is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Ny Llc. The primary component is Phytonadione.

Product ID69238-1051_0f660c0b-8fde-4d4a-a5a3-6495256796c4
NDC69238-1051
Product TypeHuman Prescription Drug
Proprietary NamePhytonadione
Generic NamePhytonadione
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-05-15
Marketing CategoryANDA / ANDA
Application NumberANDA209373
Labeler NameAmneal Pharmaceuticals NY LLC
Substance NamePHYTONADIONE
Active Ingredient Strength5 mg/1
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 69238-1051-1

1 BOTTLE in 1 CARTON (69238-1051-1) > 100 TABLET in 1 BOTTLE
Marketing Start Date2018-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69238-1051-1 [69238105101]

Phytonadione TABLET
Marketing CategoryANDA
Application NumberANDA209373
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-15

NDC 69238-1051-3 [69238105103]

Phytonadione TABLET
Marketing CategoryANDA
Application NumberANDA209373
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-15

Drug Details

Active Ingredients

IngredientStrength
PHYTONADIONE5 mg/1

OpenFDA Data

SPL SET ID:54c1c1df-0e65-4da8-9023-6cbaa0f5bd0d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198102
  • 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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