topiramate

Generic: topiramate

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

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

topiramate 50 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8828
Product ID 68788-8828_288d6b40-8c87-4f16-85a7-86166b5ac77f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090162
Listing Expiration 2026-12-31
Marketing Start 2025-02-14

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 687888828
Hyphenated Format 68788-8828

Supplemental Identifiers

RxCUI
151226
UNII
0H73WJJ391
NUI
N0000008486 N0000185506 N0000182140

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 ANDA090162 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68788-8828-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8828-3)
  • 15 TABLET, FILM COATED in 1 BOTTLE (68788-8828-5)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8828-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8828-9)
source: ndc

Packages (5)

68788-8828-1 100 TABLET, FILM COATED in 1 BOTTLE (68788-8828-1) 68788-8828-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8828-3) 68788-8828-5 15 TABLET, FILM COATED in 1 BOTTLE (68788-8828-5) 68788-8828-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8828-6) 68788-8828-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8828-9)

Ingredients (1)

topiramate (50 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": "288d6b40-8c87-4f16-85a7-86166b5ac77f", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["151226"], "spl_set_id": ["288d6b40-8c87-4f16-85a7-86166b5ac77f"], "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": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68788-8828-1)", "package_ndc": "68788-8828-1", "marketing_start_date": "20250214"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8828-3)", "package_ndc": "68788-8828-3", "marketing_start_date": "20250214"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (68788-8828-5)", "package_ndc": "68788-8828-5", "marketing_start_date": "20250214"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8828-6)", "package_ndc": "68788-8828-6", "marketing_start_date": "20250214"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8828-9)", "package_ndc": "68788-8828-9", "marketing_start_date": "20250214"}], "brand_name": "topiramate", "product_id": "68788-8828_288d6b40-8c87-4f16-85a7-86166b5ac77f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68788-8828", "generic_name": "topiramate", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "50 mg/1"}], "application_number": "ANDA090162", "marketing_category": "ANDA", "marketing_start_date": "20250214", "listing_expiration_date": "20261231"}