NDC 52565-093

AquaMEPHYTON

Phytonadione

AquaMEPHYTON 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 ID: 52565-093_2eb2025f-7602-4f3c-be99-547033e04ad7
• NDC: 52565-093
• Product Type: Human Prescription Drug
• Proprietary Name: AquaMEPHYTON
• Generic Name: Phytonadione
• Dosage Form: Injection, Emulsion
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 2018-03-07
• Marketing Category: NDA / NDA
• Application Number: NDA012223
• Labeler Name: Teligent Pharma, Inc.
• Substance Name: PHYTONADIONE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [CS],Vitamin K [EPC],Warfarin Reversal Agent [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 52565-093-05

5 AMPULE in 1 TRAY (52565-093-05) > 1 mL in 1 AMPULE

• Marketing Start Date: 2018-03-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52565-093-01 [52565009301]

AquaMEPHYTON INJECTION, EMULSION

• Marketing Category: NDA
• Application Number: NDA012223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-05-25
• Marketing End Date: 2019-02-22

NDC 52565-093-05 [52565009305]

AquaMEPHYTON INJECTION, EMULSION

• Marketing Category: NDA
• Application Number: NDA012223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-03-07
• Marketing End Date: 2019-10-17

Drug Details

Active Ingredients

Ingredient	Strength
PHYTONADIONE	10 mg/mL

OpenFDA Data

• SPL SET ID: 202757c7-caf6-44f5-9701-b89e4871df59
• Manufacturer:
  • Teligent Pharma, Inc.
• UNII:
  • A034SE7857
• RxNorm Concept Unique ID - RxCUI:
  • 1923617
  • 1670192
  • 1923622
  • 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 "AquaMEPHYTON" or generic name "Phytonadione"

NDC	Brand Name	Generic Name
52565-092	AquaMEPHYTON	phytonadione
52565-093	AquaMEPHYTON	PHYTONADIONE
0187-1704	Mephyton	phytonadione
21695-168	MEPHYTON	phytonadione
50090-1753	Mephyton	phytonadione
0404-9935	PHYTONADIONE	phytonadione
0404-9969	PHYTONADIONE	phytonadione
0904-6882	Phytonadione	Phytonadione
16714-973	Phytonadione	Phytonadione
43598-405	PHYTONADIONE	PHYTONADIONE
50268-661	Phytonadione	phytonadione
52565-142	Phytonadione	phytonadione
52565-143	Phytonadione	PHYTONADIONE
52584-043	PHYTONADIONE	phytonadione
52584-046	PHYTONADIONE	phytonadione
0409-9157	Vitamin K1	PHYTONADIONE
0409-9158	Vitamin K1	PHYTONADIONE
50090-4521	Vitamin K1	PHYTONADIONE
50090-4523	Vitamin K1	PHYTONADIONE