FDA.reportPublic FDA data

Metronidazole

Product NDC
51655-190
11-digit product format
516550190
Labeler code
51655
Product ID
51655-190_f8bf4db8-de89-4b75-b97e-b31d9b59fbd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA079067
Marketing category
ANDA
Marketing start
2015-01-15
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
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-190-202026-01-09C16284748780-19d75b9d0-cbc2-f424-e053-dadaa90a57ce1857fabd-a09d-409b-9d74-46fb82e5bb6c
51655-190-842026-01-09C16284748780-19d75b9d0-cbc2-f424-e053-dadaa90a57ce1857fabd-a09d-409b-9d74-46fb82e5bb6c
51655-190-202020-01-31C16284748780-19d75b9d0-cbc2-f424-e053-dadaa90a57ce1857fabd-a09d-409b-9d74-46fb82e5bb6c
51655-190-842020-01-31C16284748780-19d75b9d0-cbc2-f424-e053-dadaa90a57ce1857fabd-a09d-409b-9d74-46fb82e5bb6c

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [NORTHWIND PHARMACEUTICALS]2
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [NORTHWIND PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-190METRONIDAZOLE TABLET [NORTHWIND PHARMACEUTICALS]2Legacy NDC20150402_1857fabd-a09d-409b-9d74-46fb82e5bb6c.zip