zonisamide

Generic: zonisamide

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zonisamide
Generic Name zonisamide
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

zonisamide 100 mg/1

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0392
Product ID 80425-0392_19b070b3-73b3-4f4a-e063-6294a90af594
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077625
Listing Expiration 2026-12-31
Marketing Start 2024-05-23

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]
Mechanism of Action
carbonic anhydrase inhibitors [moa] p-glycoprotein inhibitors [moa]
Chemical Structure
sulfonamides [cs]
Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250392
Hyphenated Format 80425-0392

Supplemental Identifiers

RxCUI
314285
UNII
459384H98V
NUI
N0000175753 N0000008486 M0020790 N0000000235 N0000185503

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 zonisamide (source: ndc)
Generic Name zonisamide (source: ndc)
Application Number ANDA077625 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (80425-0392-1)
  • 60 CAPSULE in 1 BOTTLE (80425-0392-2)
source: ndc

Packages (2)

80425-0392-1 30 CAPSULE in 1 BOTTLE (80425-0392-1) 80425-0392-2 60 CAPSULE in 1 BOTTLE (80425-0392-2)

Ingredients (1)

zonisamide (100 mg/1)

Linked Drug Pages (1)

Zonisamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "19b070b3-73b3-4f4a-e063-6294a90af594", "openfda": {"nui": ["N0000175753", "N0000008486", "M0020790", "N0000000235", "N0000185503"], "unii": ["459384H98V"], "rxcui": ["314285"], "spl_set_id": ["19b059f0-a08a-f75a-e063-6294a90a57db"], "pharm_class_cs": ["Sulfonamides [CS]"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "pharm_class_moa": ["Carbonic Anhydrase Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (80425-0392-1)", "package_ndc": "80425-0392-1", "marketing_start_date": "20240523"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (80425-0392-2)", "package_ndc": "80425-0392-2", "marketing_start_date": "20240523"}], "brand_name": "Zonisamide", "product_id": "80425-0392_19b070b3-73b3-4f4a-e063-6294a90af594", "dosage_form": "CAPSULE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "P-Glycoprotein Inhibitors [MoA]", "Sulfonamides [CS]"], "product_ndc": "80425-0392", "generic_name": "Zonisamide", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zonisamide", "active_ingredients": [{"name": "ZONISAMIDE", "strength": "100 mg/1"}], "application_number": "ANDA077625", "marketing_category": "ANDA", "marketing_start_date": "20240523", "listing_expiration_date": "20261231"}