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
Routes
ORAL
Active Ingredients

topiramate 50 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-3461
Product ID 50090-3461_c3bc6965-397a-4657-ae62-c05a29568265
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 500903461
Hyphenated Format 50090-3461

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (50090-3461-0)
  • 90 TABLET in 1 BOTTLE (50090-3461-1)
  • 120 TABLET in 1 BOTTLE (50090-3461-2)
  • 180 TABLET in 1 BOTTLE (50090-3461-3)
source: ndc

Packages (4)

50090-3461-0 60 TABLET in 1 BOTTLE (50090-3461-0) 50090-3461-1 90 TABLET in 1 BOTTLE (50090-3461-1) 50090-3461-2 120 TABLET in 1 BOTTLE (50090-3461-2) 50090-3461-3 180 TABLET in 1 BOTTLE (50090-3461-3)

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": "c3bc6965-397a-4657-ae62-c05a29568265", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["151226", "199889"], "spl_set_id": ["f16b14a2-297f-4adb-8d7a-5f43785faef7"], "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 in 1 BOTTLE (50090-3461-0)", "package_ndc": "50090-3461-0", "marketing_start_date": "20180522"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (50090-3461-1)", "package_ndc": "50090-3461-1", "marketing_start_date": "20180523"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (50090-3461-2)", "package_ndc": "50090-3461-2", "marketing_start_date": "20180604"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (50090-3461-3)", "package_ndc": "50090-3461-3", "marketing_start_date": "20231120"}], "brand_name": "Topiramate", "product_id": "50090-3461_c3bc6965-397a-4657-ae62-c05a29568265", "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": "50090-3461", "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": "ANDA076343", "marketing_category": "ANDA", "marketing_start_date": "20140612", "listing_expiration_date": "20261231"}