topiramate

Generic: topiramate

Labeler: exelan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler exelan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

topiramate 25 mg/1

Manufacturer
EXELAN PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 76282-278
Product ID 76282-278_9c981813-533d-40b5-b9ea-5648dd7c7da0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079162
Listing Expiration 2026-12-31
Marketing Start 2020-09-07

Pharmacologic Class

Mechanism of Action
cytochrome p450 3a4 inducers [moa] cytochrome p450 2c19 inhibitors [moa]
Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282278
Hyphenated Format 76282-278

Supplemental Identifiers

RxCUI
151226 199888 199889 199890
UPC
0376282279107 0376282280103 0376282278100 0376282281100
UNII
0H73WJJ391
NUI
N0000008486 N0000185506 N0000182140

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name topiramate (source: ndc)
Generic Name topiramate (source: ndc)
Application Number ANDA079162 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (76282-278-10)
  • 60 TABLET in 1 BOTTLE (76282-278-60)
source: ndc

Packages (2)

76282-278-10 1000 TABLET in 1 BOTTLE (76282-278-10) 76282-278-60 60 TABLET in 1 BOTTLE (76282-278-60)

Ingredients (1)

topiramate (25 mg/1)

Linked Drug Pages (1)

Topiramate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9c981813-533d-40b5-b9ea-5648dd7c7da0", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0376282279107", "0376282280103", "0376282278100", "0376282281100"], "unii": ["0H73WJJ391"], "rxcui": ["151226", "199888", "199889", "199890"], "spl_set_id": ["690baf58-1ec9-463e-99b7-d601362ea56b"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_moa": ["Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["EXELAN PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (76282-278-10)", "package_ndc": "76282-278-10", "marketing_start_date": "20200907"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76282-278-60)", "package_ndc": "76282-278-60", "marketing_start_date": "20200907"}], "brand_name": "Topiramate", "product_id": "76282-278_9c981813-533d-40b5-b9ea-5648dd7c7da0", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "76282-278", "generic_name": "Topiramate", "labeler_name": "EXELAN PHARMACEUTICALS INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "25 mg/1"}], "application_number": "ANDA079162", "marketing_category": "ANDA", "marketing_start_date": "20200907", "listing_expiration_date": "20261231"}