topiramate

Generic: topiramate

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

topiramate 25 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-485
Product ID 71610-485_875c3303-147e-4bdf-98f2-8355c056e18f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079162
Listing Expiration 2026-12-31
Marketing Start 2020-09-07

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 71610485
Hyphenated Format 71610-485

Supplemental Identifiers

RxCUI
151226 199888 199889 199890
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 ANDA079162 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-485-30)
  • 90 TABLET in 1 BOTTLE (71610-485-60)
  • 120 TABLET in 1 BOTTLE (71610-485-70)
  • 180 TABLET in 1 BOTTLE (71610-485-80)
source: ndc

Packages (4)

71610-485-30 30 TABLET in 1 BOTTLE (71610-485-30) 71610-485-60 90 TABLET in 1 BOTTLE (71610-485-60) 71610-485-70 120 TABLET in 1 BOTTLE (71610-485-70) 71610-485-80 180 TABLET in 1 BOTTLE (71610-485-80)

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": "875c3303-147e-4bdf-98f2-8355c056e18f", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["151226", "199888", "199889", "199890"], "spl_set_id": ["3b18b43c-0de2-4acf-b0d5-f1b601d496de"], "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": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-485-30)", "package_ndc": "71610-485-30", "marketing_start_date": "20201110"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-485-60)", "package_ndc": "71610-485-60", "marketing_start_date": "20201110"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (71610-485-70)", "package_ndc": "71610-485-70", "marketing_start_date": "20201110"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-485-80)", "package_ndc": "71610-485-80", "marketing_start_date": "20201110"}], "brand_name": "Topiramate", "product_id": "71610-485_875c3303-147e-4bdf-98f2-8355c056e18f", "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": "71610-485", "generic_name": "Topiramate", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "25 mg/1"}], "application_number": "ANDA079162", "marketing_category": "ANDA", "marketing_start_date": "20200907", "listing_expiration_date": "20261231"}