zonisade

Generic: zonisamide

Labeler: azurity pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zonisade
Generic Name zonisamide
Labeler azurity pharmaceuticals, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

zonisamide 100 mg/5mL

Manufacturer
Azurity Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 52652-8001
Product ID 52652-8001_063fd04f-90bf-4b1f-99fe-4e2cdb5b1eea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214273
Listing Expiration 2026-12-31
Marketing Start 2022-07-15

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 526528001
Hyphenated Format 52652-8001

Supplemental Identifiers

RxCUI
2606782 2606788
UPC
0352652800119
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 zonisade (source: ndc)
Generic Name zonisamide (source: ndc)
Application Number NDA214273 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (52652-8001-1) / 150 mL in 1 BOTTLE
source: ndc

Packages (1)

52652-8001-1 1 BOTTLE in 1 CARTON (52652-8001-1) / 150 mL in 1 BOTTLE

Ingredients (1)

zonisamide (100 mg/5mL)

Linked Drug Pages (1)

ZONISADE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "063fd04f-90bf-4b1f-99fe-4e2cdb5b1eea", "openfda": {"nui": ["N0000175753", "N0000008486", "M0020790", "N0000000235", "N0000185503"], "upc": ["0352652800119"], "unii": ["459384H98V"], "rxcui": ["2606782", "2606788"], "spl_set_id": ["ac16fa15-32e9-4f92-8bc6-d8d41ae002c6"], "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": ["Azurity Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (52652-8001-1)  / 150 mL in 1 BOTTLE", "package_ndc": "52652-8001-1", "marketing_start_date": "20220715"}], "brand_name": "ZONISADE", "product_id": "52652-8001_063fd04f-90bf-4b1f-99fe-4e2cdb5b1eea", "dosage_form": "SUSPENSION", "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": "52652-8001", "generic_name": "ZONISAMIDE", "labeler_name": "Azurity Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZONISADE", "active_ingredients": [{"name": "ZONISAMIDE", "strength": "100 mg/5mL"}], "application_number": "NDA214273", "marketing_category": "NDA", "marketing_start_date": "20220715", "listing_expiration_date": "20261231"}