NDC 0409-9157

Vitamin K1

Phytonadione

Vitamin K1 is a Intramuscular; Intravenous; Subcutaneous Injection, Emulsion in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Phytonadione.

Product ID0409-9157_508953cc-85bf-4dac-9641-9dfb34de8a1f
NDC0409-9157
Product TypeHuman Prescription Drug
Proprietary NameVitamin K1
Generic NamePhytonadione
Dosage FormInjection, Emulsion
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2005-06-22
Marketing CategoryANDA / ANDA
Application NumberANDA087954
Labeler NameHospira, Inc.
Substance NamePHYTONADIONE
Active Ingredient Strength2 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 Through2020-12-31

Packaging

NDC 0409-9157-01

5 TRAY in 1 CONTAINER (0409-9157-01) > 5 AMPULE in 1 TRAY (0409-9157-50) > .5 mL in 1 AMPULE (0409-9157-31)
Marketing Start Date2005-06-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-9157-50 [00409915750]

Vitamin K1 INJECTION, EMULSION
Marketing CategoryANDA
Application NumberANDA087954
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-06-22

NDC 0409-9157-25 [00409915725]

Vitamin K1 INJECTION, EMULSION
Marketing CategoryANDA
Application NumberANDA087954
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-06-26
Marketing End Date2019-11-01

NDC 0409-9157-31 [00409915731]

Vitamin K1 INJECTION, EMULSION
Marketing CategoryANDA
Application NumberANDA087954
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-06-22

NDC 0409-9157-01 [00409915701]

Vitamin K1 INJECTION, EMULSION
Marketing CategoryANDA
Application NumberANDA087954
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-06-22

Drug Details

Active Ingredients

IngredientStrength
PHYTONADIONE2 mg/mL

OpenFDA Data

SPL SET ID:e8808230-2c44-44c6-8cab-8f29b6b34051
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1670192
  • 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 "Vitamin K1" or generic name "Phytonadione"

    NDCBrand NameGeneric Name
    0409-9157Vitamin K1PHYTONADIONE
    0409-9158Vitamin K1PHYTONADIONE
    50090-4521Vitamin K1PHYTONADIONE
    50090-4523Vitamin K1PHYTONADIONE
    52584-158Vitamin K1Vitamin K1
    55154-2388Vitamin K1Vitamin K1
    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
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