topiramate

Generic: topiramate

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

topiramate 50 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-758
Product ID 63187-758_f4311c55-f736-4e0d-a743-0b6fdd1395b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076343
Listing Expiration 2026-12-31
Marketing Start 2014-06-12

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 63187758
Hyphenated Format 63187-758

Supplemental Identifiers

RxCUI
151226
UPC
0363187758905
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 ANDA076343 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (63187-758-30)
  • 60 TABLET in 1 BOTTLE (63187-758-60)
  • 90 TABLET in 1 BOTTLE (63187-758-90)
source: ndc

Packages (3)

63187-758-30 30 TABLET in 1 BOTTLE (63187-758-30) 63187-758-60 60 TABLET in 1 BOTTLE (63187-758-60) 63187-758-90 90 TABLET in 1 BOTTLE (63187-758-90)

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": "f4311c55-f736-4e0d-a743-0b6fdd1395b2", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0363187758905"], "unii": ["0H73WJJ391"], "rxcui": ["151226"], "spl_set_id": ["57ac12ed-27f0-4f5c-96ae-a7433714b429"], "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": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (63187-758-30)", "package_ndc": "63187-758-30", "marketing_start_date": "20161003"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63187-758-60)", "package_ndc": "63187-758-60", "marketing_start_date": "20161003"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (63187-758-90)", "package_ndc": "63187-758-90", "marketing_start_date": "20161003"}], "brand_name": "Topiramate", "product_id": "63187-758_f4311c55-f736-4e0d-a743-0b6fdd1395b2", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "63187-758", "generic_name": "Topiramate", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "50 mg/1"}], "application_number": "ANDA076343", "marketing_category": "ANDA", "marketing_start_date": "20140612", "listing_expiration_date": "20261231"}