Vitamin K1

Product NDC
52584-158
11-digit product format
525840158
Labeler code
52584
Product ID
52584-158_016ebb3e-b2f6-4c73-954c-35fdba962a3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phytonadione
Dosage form
INJECTION, EMULSION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
General Injectables & Vaccines, Inc
Application
ANDA087955
Marketing category
ANDA
Marketing start
2010-09-01
Marketing end
2020-02-01
Substance
PHYTONADIONE
Active strength
10 mg/mL
Pharmacologic classes
Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [CS],Vitamin K [EPC],Warfarin Reversal Agent [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record