NDC 52565-143

Phytonadione

Phytonadione

Phytonadione 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 ID52565-143_b613e06c-a234-48eb-84f0-f85923a15a9e
NDC52565-143
Product TypeHuman Prescription Drug
Proprietary NamePhytonadione
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 Through2020-12-31

Packaging

NDC 52565-143-25

5 AMPULE in 1 TRAY (52565-143-25) > 1 mL in 1 AMPULE
Marketing Start Date2018-03-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52565-143-25 [52565014325]

Phytonadione INJECTION, EMULSION
Marketing CategoryNDA
Application NumberNDA012223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-07
Marketing End Date2020-05-20

Drug Details

Active Ingredients

IngredientStrength
PHYTONADIONE10 mg/mL

Pharmacological Class

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