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 200 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-7568
Product ID 68788-7568_d2a8ffb0-833e-40eb-b7d0-6a0d71e2d671
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078235
Listing Expiration 2026-12-31
Marketing Start 2009-03-27

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 687887568
Hyphenated Format 68788-7568

Supplemental Identifiers

RxCUI
199890
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 ANDA078235 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-7568-3)
  • 15 TABLET, FILM COATED in 1 BOTTLE (68788-7568-5)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-7568-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-7568-9)
source: ndc

Packages (4)

68788-7568-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-7568-3) 68788-7568-5 15 TABLET, FILM COATED in 1 BOTTLE (68788-7568-5) 68788-7568-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-7568-6) 68788-7568-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-7568-9)

Ingredients (1)

topiramate (200 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": "d2a8ffb0-833e-40eb-b7d0-6a0d71e2d671", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["199890"], "spl_set_id": ["2b6b0642-fb91-4641-9c51-d3be2021992b"], "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": "30 TABLET, FILM COATED in 1 BOTTLE (68788-7568-3)", "package_ndc": "68788-7568-3", "marketing_start_date": "20191227"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (68788-7568-5)", "package_ndc": "68788-7568-5", "marketing_start_date": "20191227"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-7568-6)", "package_ndc": "68788-7568-6", "marketing_start_date": "20191227"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-7568-9)", "package_ndc": "68788-7568-9", "marketing_start_date": "20191227"}], "brand_name": "topiramate", "product_id": "68788-7568_d2a8ffb0-833e-40eb-b7d0-6a0d71e2d671", "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": "68788-7568", "generic_name": "topiramate", "labeler_name": "Preferred Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "200 mg/1"}], "application_number": "ANDA078235", "marketing_category": "ANDA", "marketing_start_date": "20090327", "listing_expiration_date": "20261231"}