topiramate

Generic: topiramate

Labeler: advagen pharma ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler advagen pharma ltd
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

topiramate 25 mg/1

Manufacturer
Advagen Pharma Ltd

Identifiers & Regulatory

Product NDC 72888-229
Product ID 72888-229_382d2706-227f-1962-e063-6394a90a147b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216683
Listing Expiration 2026-12-31
Marketing Start 2025-05-27

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 72888229
Hyphenated Format 72888-229

Supplemental Identifiers

RxCUI
205315 205316 252413
UPC
0372888228051 0372888230672 0372888228679 0372888229126 0372888229676 0372888230054 0372888228129 0372888228303 0372888229607 0372888230122 0372888228600 0372888229058 0372888230603 0372888230306
UNII
0H73WJJ391
NUI
N0000008486 N0000185506 N0000182140

Packaging Origin

Original Packager
true

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 ANDA216683 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (72888-229-05)
  • 120 CAPSULE in 1 BOTTLE (72888-229-12)
  • 30 CAPSULE in 1 BOTTLE (72888-229-30)
  • 60 CAPSULE in 1 BOTTLE (72888-229-60)
  • 240 CAPSULE in 1 BOTTLE (72888-229-67)
source: ndc

Packages (5)

72888-229-05 500 CAPSULE in 1 BOTTLE (72888-229-05) 72888-229-12 120 CAPSULE in 1 BOTTLE (72888-229-12) 72888-229-30 30 CAPSULE in 1 BOTTLE (72888-229-30) 72888-229-60 60 CAPSULE in 1 BOTTLE (72888-229-60) 72888-229-67 240 CAPSULE in 1 BOTTLE (72888-229-67)

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": "382d2706-227f-1962-e063-6394a90a147b", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0372888228051", "0372888230672", "0372888228679", "0372888229126", "0372888229676", "0372888230054", "0372888228129", "0372888228303", "0372888229607", "0372888230122", "0372888228600", "0372888229058", "0372888230603", "0372888230306"], "unii": ["0H73WJJ391"], "rxcui": ["205315", "205316", "252413"], "spl_set_id": ["48169bbc-4fb2-4bc4-9bdd-de71bf7722df"], "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": ["Advagen Pharma Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (72888-229-05)", "package_ndc": "72888-229-05", "marketing_start_date": "20250527"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (72888-229-12)", "package_ndc": "72888-229-12", "marketing_start_date": "20250527"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (72888-229-30)", "package_ndc": "72888-229-30", "marketing_start_date": "20250527"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (72888-229-60)", "package_ndc": "72888-229-60", "marketing_start_date": "20250527"}, {"sample": false, "description": "240 CAPSULE in 1 BOTTLE (72888-229-67)", "package_ndc": "72888-229-67", "marketing_start_date": "20250527"}], "brand_name": "Topiramate", "product_id": "72888-229_382d2706-227f-1962-e063-6394a90a147b", "dosage_form": "CAPSULE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72888-229", "generic_name": "Topiramate", "labeler_name": "Advagen Pharma Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "25 mg/1"}], "application_number": "ANDA216683", "marketing_category": "ANDA", "marketing_start_date": "20250527", "listing_expiration_date": "20261231"}