Metronidazole

Product NDC
0781-7080
11-digit product format
007817080
Labeler code
0781
Product ID
0781-7080_327f4ef7-b4c7-4e46-8ee4-e4a78f95ff76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
GEL
Route
TOPICAL
Labeler
Sandoz Inc.
Application
ANDA090903
Marketing category
ANDA
Marketing start
2013-07-01
Marketing end
0000-00-00
Substance
METRONIDAZOLE
Active strength
10 mg/g
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
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
0781-7080-35007817080351 TUBE in 1 CARTON (0781-7080-35) > 60 g in 1 TUBE1 tube2013-07-010000-00-00NoNoCurrent
0781-7080-55007817080551 BOTTLE, PUMP in 1 CARTON (0781-7080-55) > 55 g in 1 BOTTLE, PUMP2013-07-010000-00-00NoNoCurrent