topiramate

Generic: topiramate

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

topiramate 100 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-004
Product ID 72789-004_37663bc9-c517-c973-e063-6394a90aed91
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090278
Listing Expiration 2026-12-31
Marketing Start 2014-12-15

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 72789004
Hyphenated Format 72789-004

Supplemental Identifiers

RxCUI
199889
UPC
0372789004303
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 ANDA090278 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-004-21)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-004-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-004-60)
source: ndc

Packages (3)

72789-004-21 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-004-21) 72789-004-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-004-30) 72789-004-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-004-60)

Ingredients (1)

topiramate (100 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": "37663bc9-c517-c973-e063-6394a90aed91", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "upc": ["0372789004303"], "unii": ["0H73WJJ391"], "rxcui": ["199889"], "spl_set_id": ["e846124d-e9e6-42c7-83f1-5df170d3f70b"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-004-21)", "package_ndc": "72789-004-21", "marketing_start_date": "20190820"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-004-30)", "package_ndc": "72789-004-30", "marketing_start_date": "20190820"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-004-60)", "package_ndc": "72789-004-60", "marketing_start_date": "20200317"}], "brand_name": "Topiramate", "product_id": "72789-004_37663bc9-c517-c973-e063-6394a90aed91", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "72789-004", "generic_name": "Topiramate", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "100 mg/1"}], "application_number": "ANDA090278", "marketing_category": "ANDA", "marketing_start_date": "20141215", "listing_expiration_date": "20261231"}