zonisamide

Generic: zonisamide

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

Drug Facts

Product Profile

Brand Name zonisamide
Generic Name zonisamide
Labeler exelan pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

zonisamide 25 mg/1

Manufacturer
Exelan Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 76282-226
Product ID 76282-226_5b700833-52ca-46ef-8874-67b56595db24
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077869
Listing Expiration 2026-12-31
Marketing Start 2021-03-15

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 76282226
Hyphenated Format 76282-226

Supplemental Identifiers

RxCUI
314285 403966 403967
UPC
0376282228013 0376282226019 0376282227016
UNII
459384H98V
NUI
N0000175753 N0000008486 M0020790 N0000000235 N0000185503

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 zonisamide (source: ndc)
Generic Name zonisamide (source: ndc)
Application Number ANDA077869 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (76282-226-01)
source: ndc

Packages (1)

76282-226-01 100 CAPSULE in 1 BOTTLE (76282-226-01)

Ingredients (1)

zonisamide (25 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": "5b700833-52ca-46ef-8874-67b56595db24", "openfda": {"nui": ["N0000175753", "N0000008486", "M0020790", "N0000000235", "N0000185503"], "upc": ["0376282228013", "0376282226019", "0376282227016"], "unii": ["459384H98V"], "rxcui": ["314285", "403966", "403967"], "spl_set_id": ["24284954-0c29-458f-a9f8-97a7ad418ca7"], "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": ["Exelan Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (76282-226-01)", "package_ndc": "76282-226-01", "marketing_start_date": "20210315"}], "brand_name": "Zonisamide", "product_id": "76282-226_5b700833-52ca-46ef-8874-67b56595db24", "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": "76282-226", "generic_name": "Zonisamide", "labeler_name": "Exelan Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zonisamide", "active_ingredients": [{"name": "ZONISAMIDE", "strength": "25 mg/1"}], "application_number": "ANDA077869", "marketing_category": "ANDA", "marketing_start_date": "20210315", "listing_expiration_date": "20261231"}