Phytonadione

Product NDC
69097-540
11-digit product format
690970540
Labeler code
69097
Product ID
69097-540_01387312-f1a6-483a-8d2e-3c604864c2e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phytonadione
Dosage form
INJECTION, EMULSION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Cipla USA Inc.
Application
ANDA212424
Marketing category
ANDA
Marketing start
2022-04-23
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-540-49690970540495 TRAY in 1 CARTON (69097-540-49) > 5 AMPULE in 1 TRAY (69097-540-30) > .5 mL in 1 AMPULE5 tray2022-04-230000-00-00NoNoCurrent