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 100 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5309
Product ID 50090-5309_3a4d1f5a-8e48-45a1-944a-5e49c6db501c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078235
Listing Expiration 2026-12-31
Marketing Start 2009-03-27

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 500905309
Hyphenated Format 50090-5309

Supplemental Identifiers

RxCUI
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 ANDA078235 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (50090-5309-0)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-5309-1)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-5309-2)
  • 180 TABLET, FILM COATED in 1 BOTTLE (50090-5309-3)
source: ndc

Packages (4)

50090-5309-0 60 TABLET, FILM COATED in 1 BOTTLE (50090-5309-0) 50090-5309-1 30 TABLET, FILM COATED in 1 BOTTLE (50090-5309-1) 50090-5309-2 90 TABLET, FILM COATED in 1 BOTTLE (50090-5309-2) 50090-5309-3 180 TABLET, FILM COATED in 1 BOTTLE (50090-5309-3)

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": "3a4d1f5a-8e48-45a1-944a-5e49c6db501c", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["199889"], "spl_set_id": ["674c2c2e-014a-43a1-91a7-7214ffc4b1d7"], "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 (50090-5309-0)", "package_ndc": "50090-5309-0", "marketing_start_date": "20201028"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-5309-1)", "package_ndc": "50090-5309-1", "marketing_start_date": "20201028"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-5309-2)", "package_ndc": "50090-5309-2", "marketing_start_date": "20201028"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (50090-5309-3)", "package_ndc": "50090-5309-3", "marketing_start_date": "20220310"}], "brand_name": "topiramate", "product_id": "50090-5309_3a4d1f5a-8e48-45a1-944a-5e49c6db501c", "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": "50090-5309", "generic_name": "topiramate", "labeler_name": "A-S Medication Solutions", "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": "20090327", "listing_expiration_date": "20261231"}