topiramate

Generic: topiramate

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topiramate
Generic Name topiramate
Labeler quality care products, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

topiramate 25 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 83008-012
Product ID 83008-012_fa8f0050-15cf-4705-a6f0-a24df4210556
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090162
Marketing Start 2023-03-23
Marketing End 2026-03-31

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 83008012
Hyphenated Format 83008-012

Supplemental Identifiers

RxCUI
151226 199888
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 ANDA090162 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (83008-012-60)
source: ndc

Packages (1)

83008-012-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (83008-012-60)

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": "fa8f0050-15cf-4705-a6f0-a24df4210556", "openfda": {"nui": ["N0000008486", "N0000185506", "N0000182140"], "unii": ["0H73WJJ391"], "rxcui": ["151226", "199888"], "spl_set_id": ["f66a529d-ba9d-4c8b-b58e-8fbcbcb8a11b"], "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": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (83008-012-60)", "package_ndc": "83008-012-60", "marketing_end_date": "20260331", "marketing_start_date": "20230509"}], "brand_name": "topiramate", "product_id": "83008-012_fa8f0050-15cf-4705-a6f0-a24df4210556", "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": "83008-012", "generic_name": "topiramate", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "topiramate", "active_ingredients": [{"name": "TOPIRAMATE", "strength": "25 mg/1"}], "application_number": "ANDA090162", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20230323"}