NDC 52584-158

Vitamin K1

Phytonadione

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

• Product ID: 52584-158_016ebb3e-b2f6-4c73-954c-35fdba962a3c
• NDC: 52584-158
• Product Type: Human Prescription Drug
• Proprietary Name: Vitamin K1
• Generic Name: Phytonadione
• Dosage Form: Injection, Emulsion
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 2010-09-01
• Marketing End Date: 2020-02-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA087955
• Labeler Name: General Injectables & Vaccines, 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

Packaging

NDC 52584-158-01

1 AMPULE in 1 BAG (52584-158-01) > 1 mL in 1 AMPULE

• Marketing Start Date: 2010-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52584-158-01 [52584015801]

Vitamin K1 INJECTION, EMULSION

• Marketing Category: ANDA
• Application Number: ANDA087955
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-09-01
• Marketing End Date: 2020-02-01

Drug Details

Active Ingredients

Ingredient	Strength
PHYTONADIONE	10 mg/mL

OpenFDA Data

• SPL SET ID: ad54cca8-db8a-4cd7-aff9-464ccdda6950
• Manufacturer:
  • General Injectables & Vaccines, Inc
• UNII:
  • A034SE7857
• RxNorm Concept Unique ID - RxCUI:
  • 1670192

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"

NDC	Brand Name	Generic Name
0409-9157	Vitamin K1	PHYTONADIONE
0409-9158	Vitamin K1	PHYTONADIONE
50090-4521	Vitamin K1	PHYTONADIONE
50090-4523	Vitamin K1	PHYTONADIONE
52584-158	Vitamin K1	Vitamin K1
55154-2388	Vitamin K1	Vitamin K1
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