topiramate

Generic: topiramate

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

topiramate 50 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8139
Product ID 0615-8139_8346efad-e6ee-4384-b042-95683f943e8e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077627
Marketing Start 2009-03-27
Marketing End 2026-06-30

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 06158139
Hyphenated Format 0615-8139

Supplemental Identifiers

RxCUI
151226 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 ANDA077627 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8139-39)
source: ndc

Packages (1)

0615-8139-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8139-39)

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": "8346efad-e6ee-4384-b042-95683f943e8e", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["151226", "199888", "199889"], "spl_set_id": ["b0036d28-ca99-42c6-81ad-3c93f4a844a1"], "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": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8139-39)", "package_ndc": "0615-8139-39", "marketing_end_date": "20260630", "marketing_start_date": "20181207"}], "brand_name": "Topiramate", "product_id": "0615-8139_8346efad-e6ee-4384-b042-95683f943e8e", "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": "0615-8139", "generic_name": "Topiramate", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "50 mg/1"}], "application_number": "ANDA077627", "marketing_category": "ANDA", "marketing_end_date": "20260630", "marketing_start_date": "20090327"}