Metronidazole

Product NDC
58118-0527
11-digit product format
581180527
Labeler code
58118
Product ID
58118-0527_b025a838-2ba7-8983-e053-2a95a90a9c2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA203458
Marketing category
ANDA
Marketing start
2014-06-01
Marketing end
0000-00-00
Substance
METRONIDAZOLE
Active strength
500 mg/1
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58118-0527-82024-01-30C16284748780-11030e365-016c-111a-e063-dadaa90a10e2ac6c19c2-db32-45a3-8a34-a5f459640935

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-0527METRONIDAZOLE TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE, LLC]6Legacy NDC20200926_ac6c19c2-db32-45a3-8a34-a5f459640935.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58118-0527-85811805270830 TABLET, FILM COATED in 1 BLISTER PACK (58118-0527-8) 2017-04-180000-00-00NoNoCurrent