topiramate

Generic: topiramate

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

topiramate 100 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-137
Product ID 82009-137_65647e58-53dd-4a6a-98ce-648258b354c9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078235
Listing Expiration 2026-12-31
Marketing Start 2023-07-24

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 82009137
Hyphenated Format 82009-137

Supplemental Identifiers

RxCUI
151226 199888 199889
UPC
0382009136059
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
  • 100 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (82009-137-05)
source: ndc

Packages (1)

82009-137-05 500 TABLET, FILM COATED in 1 BOTTLE (82009-137-05)

Ingredients (1)

topiramate (100 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": "65647e58-53dd-4a6a-98ce-648258b354c9", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0382009136059"], "unii": ["0H73WJJ391"], "rxcui": ["151226", "199888", "199889"], "spl_set_id": ["9dae6824-6913-42de-b98a-cdcb0d3b4a46"], "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": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (82009-137-05)", "package_ndc": "82009-137-05", "marketing_start_date": "20230724"}], "brand_name": "topiramate", "product_id": "82009-137_65647e58-53dd-4a6a-98ce-648258b354c9", "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": "82009-137", "generic_name": "topiramate", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "100 mg/1"}], "application_number": "ANDA078235", "marketing_category": "ANDA", "marketing_start_date": "20230724", "listing_expiration_date": "20261231"}