NDC 76329-1240

Phytonadione

Phytonadione

Phytonadione is a Intramuscular; Intravenous; Subcutaneous Injection, Emulsion in the Human Prescription Drug category. It is labeled and distributed by International Medication Systems, Limited. The primary component is Phytonadione.

Product ID76329-1240_6ae3bac4-5a2a-47ff-b613-2014518a8365
NDC76329-1240
Product TypeHuman Prescription Drug
Proprietary NamePhytonadione
Generic NamePhytonadione
Dosage FormInjection, Emulsion
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2003-04-18
Marketing CategoryANDA / ANDA
Application NumberANDA083722
Labeler NameInternational Medication Systems, Limited
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 FlagN
Listing Certified Through2022-12-31

Packaging

NDC 76329-1240-1

1 SYRINGE in 1 CARTON (76329-1240-1) > .5 mL in 1 SYRINGE
Marketing Start Date2003-04-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76329-1240-1 [76329124001]

Phytonadione INJECTION, EMULSION
Marketing CategoryANDA
Application NumberANDA083722
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2003-04-18

NDC 76329-1240-5 [76329124005]

Phytonadione INJECTION, EMULSION
Marketing CategoryANDA
Application NumberANDA083722
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2003-04-18
Marketing End Date2015-04-16

Drug Details

Active Ingredients

IngredientStrength
PHYTONADIONE1 mg/.5mL

OpenFDA Data

SPL SET ID:e0b0c8f1-75be-4f25-898a-7b97b608c615
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]