topiramate

Generic: topiramate

Labeler: vitruvias therapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler vitruvias therapeutics, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

topiramate 100 mg/1

Manufacturer
Vitruvias Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 69680-179
Product ID 69680-179_320e2f48-a1d3-42c0-a482-c6982f9ef1ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215638
Listing Expiration 2026-12-31
Marketing Start 2025-04-07

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 69680179
Hyphenated Format 69680-179

Supplemental Identifiers

RxCUI
1494769 1812419 1812421 1812425 1812427
UPC
0369680179308 0369680177304 0369680178301 0369680181301 0369680180304
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 ANDA215638 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-179-30)
source: ndc

Packages (1)

69680-179-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-179-30)

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": "320e2f48-a1d3-42c0-a482-c6982f9ef1ea", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0369680179308", "0369680177304", "0369680178301", "0369680181301", "0369680180304"], "unii": ["0H73WJJ391"], "rxcui": ["1494769", "1812419", "1812421", "1812425", "1812427"], "spl_set_id": ["a9d7c5ef-daf9-4f97-8673-7f4a2007f408"], "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": ["Vitruvias Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-179-30)", "package_ndc": "69680-179-30", "marketing_start_date": "20250407"}], "brand_name": "Topiramate", "product_id": "69680-179_320e2f48-a1d3-42c0-a482-c6982f9ef1ea", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "69680-179", "generic_name": "Topiramate", "labeler_name": "Vitruvias Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "100 mg/1"}], "application_number": "ANDA215638", "marketing_category": "ANDA", "marketing_start_date": "20250407", "listing_expiration_date": "20261231"}