zonisamide

Generic: zonisamide

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zonisamide
Generic Name zonisamide
Labeler avpak
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

zonisamide 100 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-816
Product ID 50268-816_41ac7d6a-8113-6e97-e063-6394a90a088b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077869
Listing Expiration 2026-12-31
Marketing Start 2014-07-02

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 50268816
Hyphenated Format 50268-816

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 ANDA077869 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-816-15) / 1 CAPSULE in 1 BLISTER PACK (50268-816-11)
source: ndc

Packages (1)

50268-816-15 50 BLISTER PACK in 1 BOX (50268-816-15) / 1 CAPSULE in 1 BLISTER PACK (50268-816-11)

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": "41ac7d6a-8113-6e97-e063-6394a90a088b", "openfda": {"nui": ["N0000175753", "N0000008486", "M0020790", "N0000000235", "N0000185503"], "unii": ["459384H98V"], "rxcui": ["314285"], "spl_set_id": ["b20a51ef-255e-1eb0-c0e1-461cde46b887"], "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": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-816-15)  / 1 CAPSULE in 1 BLISTER PACK (50268-816-11)", "package_ndc": "50268-816-15", "marketing_start_date": "20140702"}], "brand_name": "Zonisamide", "product_id": "50268-816_41ac7d6a-8113-6e97-e063-6394a90a088b", "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": "50268-816", "generic_name": "Zonisamide", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zonisamide", "active_ingredients": [{"name": "ZONISAMIDE", "strength": "100 mg/1"}], "application_number": "ANDA077869", "marketing_category": "ANDA", "marketing_start_date": "20140702", "listing_expiration_date": "20261231"}