topiramate

Generic: topiramate

Labeler: xlcare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler xlcare pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

topiramate 200 mg/1

Manufacturer
XLCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72865-316
Product ID 72865-316_297988b4-69fb-4691-92e0-ee5da80b0125
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215414
Listing Expiration 2026-12-31
Marketing Start 2025-07-10

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 72865316
Hyphenated Format 72865-316

Supplemental Identifiers

RxCUI
151226 199888 199889 199890
UPC
0372865314104 0372865315606 0372865313602 0372865315101 0372865313107 0372865316108 0372865314609 0372865316603
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 ANDA215414 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (72865-316-10)
  • 60 TABLET in 1 BOTTLE (72865-316-60)
source: ndc

Packages (2)

72865-316-10 1000 TABLET in 1 BOTTLE (72865-316-10) 72865-316-60 60 TABLET in 1 BOTTLE (72865-316-60)

Ingredients (1)

topiramate (200 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": "297988b4-69fb-4691-92e0-ee5da80b0125", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0372865314104", "0372865315606", "0372865313602", "0372865315101", "0372865313107", "0372865316108", "0372865314609", "0372865316603"], "unii": ["0H73WJJ391"], "rxcui": ["151226", "199888", "199889", "199890"], "spl_set_id": ["546103e1-ea6e-466b-b0de-b1ff8c494512"], "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": ["XLCare Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (72865-316-10)", "package_ndc": "72865-316-10", "marketing_start_date": "20250710"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (72865-316-60)", "package_ndc": "72865-316-60", "marketing_start_date": "20250710"}], "brand_name": "TOPIRAMATE", "product_id": "72865-316_297988b4-69fb-4691-92e0-ee5da80b0125", "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": "72865-316", "generic_name": "Topiramate", "labeler_name": "XLCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOPIRAMATE", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "200 mg/1"}], "application_number": "ANDA215414", "marketing_category": "ANDA", "marketing_start_date": "20250710", "listing_expiration_date": "20261231"}