METRONIDAZOLE

Product NDC
52584-811
11-digit product format
525840811
Labeler code
52584
Product ID
52584-811_2f91b278-94b7-4d14-9add-dbeba67c3015
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METRONIDAZOLE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
General Injectables and Vaccines, Inc.
Application
NDA018890
Marketing category
NDA
Marketing start
2018-07-02
Marketing end
0000-00-00
Substance
METRONIDAZOLE
Active strength
500 mg/100mL
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52584-811-24525840811241 BAG in 1 BAG (52584-811-24) > 100 mL in 1 BAG1 bag2018-07-020000-00-00NoNoCurrent