zonegran

Generic: zonisamide

Labeler: advanz pharma (us) corp.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zonegran
Generic Name zonisamide
Labeler advanz pharma (us) corp.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

zonisamide 25 mg/1

Manufacturer
Advanz Pharma (US) Corp.

Identifiers & Regulatory

Product NDC 59212-681
Product ID 59212-681_e3848741-066e-4ee2-bf13-0b4c1d32b3c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020789
Listing Expiration 2026-12-31
Marketing Start 2000-03-27

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 59212681
Hyphenated Format 59212-681

Supplemental Identifiers

RxCUI
284408 314285 403966 404725
UPC
0359212680105
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 zonegran (source: ndc)
Generic Name zonisamide (source: ndc)
Application Number NDA020789 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (59212-681-10)
source: ndc

Packages (1)

59212-681-10 100 CAPSULE in 1 BOTTLE (59212-681-10)

Ingredients (1)

zonisamide (25 mg/1)

Linked Drug Pages (1)

Zonegran ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e3848741-066e-4ee2-bf13-0b4c1d32b3c2", "openfda": {"nui": ["N0000175753", "N0000008486", "M0020790", "N0000000235", "N0000185503"], "upc": ["0359212680105"], "unii": ["459384H98V"], "rxcui": ["284408", "314285", "403966", "404725"], "spl_set_id": ["d12de43e-3ac3-4335-bc85-70d7366a91eb"], "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": ["Advanz Pharma (US) Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (59212-681-10)", "package_ndc": "59212-681-10", "marketing_start_date": "20000327"}], "brand_name": "Zonegran", "product_id": "59212-681_e3848741-066e-4ee2-bf13-0b4c1d32b3c2", "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": "59212-681", "generic_name": "Zonisamide", "labeler_name": "Advanz Pharma (US) Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zonegran", "active_ingredients": [{"name": "ZONISAMIDE", "strength": "25 mg/1"}], "application_number": "NDA020789", "marketing_category": "NDA", "marketing_start_date": "20000327", "listing_expiration_date": "20261231"}