TOPIRAMATE

Product NDC: 51655-032
11-digit product format: 516550032
Labeler code: 51655
Product ID: 51655-032_28d953fd-d53b-421c-8728-d39d007a327c
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: 2015-02-10
Marketing end: 0000-00-00
Substance: TOPIRAMATE
Active strength: 25 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: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-032-52	2026-01-02	C162847	48780-1	9d75b9d0-b2c3-f424-e053-dadaa90a57ce	d3854fff-98ac-40a9-9929-7c4fdd223e82
51655-032-52	2020-01-31	C162847	48780-1	9d75b9d0-b2c3-f424-e053-dadaa90a57ce	d3854fff-98ac-40a9-9929-7c4fdd223e82

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
TOPIRAMATE	ACTIVE INGREDIENT	0H73WJJ391	TOPIRAMATE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	1
TOPIRAMATE	ACTIVE MOIETY	0H73WJJ391	TOPIRAMATE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-032	TOPIRAMATE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	1	Legacy NDC	20150325_d3854fff-98ac-40a9-9929-7c4fdd223e82.zip