PHYTONADIONE

Product NDC
52584-046
11-digit product format
525840046
Labeler code
52584
Product ID
52584-046_ed5403c8-e4f3-406d-bb2c-26d7864246e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phytonadione
Dosage form
INJECTION, EMULSION
Route
PARENTERAL
Labeler
General Injectables & Vaccines, Inc
Application
ANDA083722
Marketing category
ANDA
Marketing start
2014-01-06
Marketing end
2023-08-31
Substance
PHYTONADIONE
Active strength
1 mg/.5mL
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52584-046-01525840046011 BOX in 1 BAG (52584-046-01) > 1 SYRINGE in 1 BOX > .5 mL in 1 SYRINGE1 box2014-01-060000-00-00NoNoCurrent