FDA.reportPublic FDA data

Topiramate

Product NDC
51655-609
11-digit product format
516550609
Labeler code
51655
Product ID
51655-609_397d5ce6-59c1-4b03-be16-dc55f8be0f94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA077627
Marketing category
ANDA
Marketing start
2014-11-06
Marketing end
0000-00-00
Substance
TOPIRAMATE
Active strength
50 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-609-262026-01-02C16284748780-19d75b9d0-2d73-f424-e053-dadaa90a57ce13648371-f6c0-4567-a641-b074280edc96
51655-609-522026-01-02C16284748780-19d75b9d0-2d73-f424-e053-dadaa90a57ce13648371-f6c0-4567-a641-b074280edc96
51655-609-262020-01-31C16284748780-19d75b9d0-2d73-f424-e053-dadaa90a57ce13648371-f6c0-4567-a641-b074280edc96
51655-609-522020-01-31C16284748780-19d75b9d0-2d73-f424-e053-dadaa90a57ce13648371-f6c0-4567-a641-b074280edc96

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]2
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-609TOPIRAMATE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]2Legacy NDC20150319_13648371-f6c0-4567-a641-b074280edc96.zip