topiramate

Generic: topiramate

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

topiramate 25 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6928
Product ID 0904-6928_f0ebb44e-f201-4e78-9bfd-76bbd1ff8828
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 09046928
Hyphenated Format 0904-6928

Supplemental Identifiers

RxCUI
199888 199889
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
  • 25 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-6928-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6928-61 100 BLISTER PACK in 1 CARTON (0904-6928-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "f0ebb44e-f201-4e78-9bfd-76bbd1ff8828", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["199888", "199889"], "spl_set_id": ["6fb00bd8-c49e-46ef-9d6b-1b602e1d11d8"], "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": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6928-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6928-61", "marketing_start_date": "20090327"}], "brand_name": "topiramate", "product_id": "0904-6928_f0ebb44e-f201-4e78-9bfd-76bbd1ff8828", "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": "0904-6928", "generic_name": "topiramate", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "25 mg/1"}], "application_number": "ANDA078235", "marketing_category": "ANDA", "marketing_start_date": "20090327", "listing_expiration_date": "20261231"}