topiramate

Generic: topiramate

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

topiramate 50 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-2203
Product ID 50090-2203_5c0321da-e5aa-4817-bf12-3212f9becaa0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090162
Listing Expiration 2026-12-31
Marketing Start 2013-07-01

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 500902203
Hyphenated Format 50090-2203

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 ANDA090162 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (50090-2203-0)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-2203-1)
  • 120 TABLET, FILM COATED in 1 BOTTLE (50090-2203-2)
  • 180 TABLET, FILM COATED in 1 BOTTLE (50090-2203-3)
source: ndc

Packages (4)

50090-2203-0 60 TABLET, FILM COATED in 1 BOTTLE (50090-2203-0) 50090-2203-1 90 TABLET, FILM COATED in 1 BOTTLE (50090-2203-1) 50090-2203-2 120 TABLET, FILM COATED in 1 BOTTLE (50090-2203-2) 50090-2203-3 180 TABLET, FILM COATED in 1 BOTTLE (50090-2203-3)

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": "5c0321da-e5aa-4817-bf12-3212f9becaa0", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["151226", "199888", "199889"], "spl_set_id": ["a5cffe7a-fdee-487a-bafb-a2d43e76c23c"], "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": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (50090-2203-0)", "package_ndc": "50090-2203-0", "marketing_start_date": "20151029"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-2203-1)", "package_ndc": "50090-2203-1", "marketing_start_date": "20151029"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (50090-2203-2)", "package_ndc": "50090-2203-2", "marketing_start_date": "20151029"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (50090-2203-3)", "package_ndc": "50090-2203-3", "marketing_start_date": "20240202"}], "brand_name": "topiramate", "product_id": "50090-2203_5c0321da-e5aa-4817-bf12-3212f9becaa0", "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": "50090-2203", "generic_name": "topiramate", "labeler_name": "A-S Medication Solutions", "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": "20130701", "listing_expiration_date": "20261231"}