Metronidazole

Product NDC
53002-7340
11-digit product format
530027340
Labeler code
53002
Product ID
53002-7340_2cc04b8c-3001-40dd-a52b-793736241b61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
GEL
Route
VAGINAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA077264
Marketing category
ANDA
Marketing start
2006-10-31
Marketing end
0000-00-00
Substance
METRONIDAZOLE
Active strength
8 mg/g
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-7340-1530027340011 TUBE, WITH APPLICATOR in 1 CARTON (53002-7340-1) > 70 g in 1 TUBE, WITH APPLICATOR2018-10-010000-00-00NoNoCurrent