topiramate

Generic: topiramate

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler zydus lifesciences limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

topiramate 25 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 65841-647
Product ID 65841-647_85c62092-3b8c-43af-a980-e2d959e0c341
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 65841647
Hyphenated Format 65841-647

Supplemental Identifiers

RxCUI
151226 199888 199889 199890
UPC
0368382141149 0368382139146
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 ANDA078235 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65841-647-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65841-647-05)
  • 60 TABLET, FILM COATED in 1 BOTTLE (65841-647-14)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65841-647-16)
source: ndc

Packages (4)

65841-647-01 100 TABLET, FILM COATED in 1 BOTTLE (65841-647-01) 65841-647-05 500 TABLET, FILM COATED in 1 BOTTLE (65841-647-05) 65841-647-14 60 TABLET, FILM COATED in 1 BOTTLE (65841-647-14) 65841-647-16 90 TABLET, FILM COATED in 1 BOTTLE (65841-647-16)

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": "85c62092-3b8c-43af-a980-e2d959e0c341", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0368382141149", "0368382139146"], "unii": ["0H73WJJ391"], "rxcui": ["151226", "199888", "199889", "199890"], "spl_set_id": ["57016639-89fe-43ad-89c4-5e7a756dddec"], "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": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65841-647-01)", "package_ndc": "65841-647-01", "marketing_start_date": "20090327"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65841-647-05)", "package_ndc": "65841-647-05", "marketing_start_date": "20090327"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (65841-647-14)", "package_ndc": "65841-647-14", "marketing_start_date": "20090327"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65841-647-16)", "package_ndc": "65841-647-16", "marketing_start_date": "20090327"}], "brand_name": "topiramate", "product_id": "65841-647_85c62092-3b8c-43af-a980-e2d959e0c341", "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": "65841-647", "generic_name": "topiramate", "labeler_name": "Zydus Lifesciences Limited", "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"}