topiramate

Generic: topiramate

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

topiramate 50 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0214
Product ID 80425-0214_2a9aa671-d0a0-2254-e063-6294a90a9f79
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090162
Listing Expiration 2026-12-31
Marketing Start 2023-01-03

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 804250214
Hyphenated Format 80425-0214

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
  • 30 TABLET, FILM COATED in 1 BOTTLE (80425-0214-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (80425-0214-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (80425-0214-3)
source: ndc

Packages (3)

80425-0214-1 30 TABLET, FILM COATED in 1 BOTTLE (80425-0214-1) 80425-0214-2 60 TABLET, FILM COATED in 1 BOTTLE (80425-0214-2) 80425-0214-3 90 TABLET, FILM COATED in 1 BOTTLE (80425-0214-3)

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": "2a9aa671-d0a0-2254-e063-6294a90a9f79", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["151226"], "spl_set_id": ["f16065c0-9949-9ac4-e053-2995a90a3b02"], "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": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0214-1)", "package_ndc": "80425-0214-1", "marketing_start_date": "20230103"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0214-2)", "package_ndc": "80425-0214-2", "marketing_start_date": "20230103"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (80425-0214-3)", "package_ndc": "80425-0214-3", "marketing_start_date": "20230103"}], "brand_name": "Topiramate", "product_id": "80425-0214_2a9aa671-d0a0-2254-e063-6294a90a9f79", "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": "80425-0214", "generic_name": "Topiramate", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "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": "20230103", "listing_expiration_date": "20261231"}