topiramate

Generic: topiramate

Labeler: golden state medical supply, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler golden state medical supply, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

topiramate 25 mg/1

Manufacturer
Golden State Medical Supply, Inc.

Identifiers & Regulatory

Product NDC 51407-894
Product ID 51407-894_2f8ccf6c-5e9f-383e-e063-6394a90ad933
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217694
Listing Expiration 2026-12-31
Marketing Start 2023-12-05

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 51407894
Hyphenated Format 51407-894

Supplemental Identifiers

RxCUI
205315 205316
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 ANDA217694 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (51407-894-60)
source: ndc

Packages (1)

51407-894-60 60 CAPSULE in 1 BOTTLE, PLASTIC (51407-894-60)

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": "2f8ccf6c-5e9f-383e-e063-6394a90ad933", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["205315", "205316"], "spl_set_id": ["163e9f2d-27be-6d3f-e063-6394a90a5884"], "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": ["Golden State Medical Supply, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (51407-894-60)", "package_ndc": "51407-894-60", "marketing_start_date": "20240319"}], "brand_name": "Topiramate", "product_id": "51407-894_2f8ccf6c-5e9f-383e-e063-6394a90ad933", "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": "51407-894", "generic_name": "Topiramate", "labeler_name": "Golden State Medical Supply, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "25 mg/1"}], "application_number": "ANDA217694", "marketing_category": "ANDA", "marketing_start_date": "20231205", "listing_expiration_date": "20261231"}