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 25 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4614
Product ID 50090-4614_3c2cea8a-2805-4919-80f5-0bb2a6d12229
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076343
Listing Expiration 2027-12-31
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 500904614
Hyphenated Format 50090-4614

Supplemental Identifiers

RxCUI
199888
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
  • 25 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (50090-4614-0)
  • 90 TABLET in 1 BOTTLE (50090-4614-1)
  • 30 TABLET in 1 BOTTLE (50090-4614-2)
source: ndc

Packages (3)

50090-4614-0 60 TABLET in 1 BOTTLE (50090-4614-0) 50090-4614-1 90 TABLET in 1 BOTTLE (50090-4614-1) 50090-4614-2 30 TABLET in 1 BOTTLE (50090-4614-2)

Ingredients (1)

topiramate (25 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": "3c2cea8a-2805-4919-80f5-0bb2a6d12229", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["199888"], "spl_set_id": ["7f1e4475-6326-47a3-a317-b04b74b7c109"], "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 (50090-4614-0)", "package_ndc": "50090-4614-0", "marketing_start_date": "20191016"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (50090-4614-1)", "package_ndc": "50090-4614-1", "marketing_start_date": "20191016"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-4614-2)", "package_ndc": "50090-4614-2", "marketing_start_date": "20191016"}], "brand_name": "Topiramate", "product_id": "50090-4614_3c2cea8a-2805-4919-80f5-0bb2a6d12229", "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": "50090-4614", "generic_name": "Topiramate", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "25 mg/1"}], "application_number": "ANDA076343", "marketing_category": "ANDA", "marketing_start_date": "20140612", "listing_expiration_date": "20271231"}