zonisamide

Generic: zonisamide

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zonisamide
Generic Name zonisamide
Labeler remedyrepack inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

zonisamide 50 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4349
Product ID 70518-4349_365be0d1-cb8d-861b-e063-6294a90a9d8b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077645
Listing Expiration 2026-12-31
Marketing Start 2025-05-30

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 705184349
Hyphenated Format 70518-4349

Supplemental Identifiers

RxCUI
403967
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 ANDA077645 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 POUCH in 1 BOX (70518-4349-0) / 1 CAPSULE in 1 POUCH (70518-4349-1)
source: ndc

Packages (1)

70518-4349-0 100 POUCH in 1 BOX (70518-4349-0) / 1 CAPSULE in 1 POUCH (70518-4349-1)

Ingredients (1)

zonisamide (50 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": "365be0d1-cb8d-861b-e063-6294a90a9d8b", "openfda": {"nui": ["N0000175753", "N0000008486", "M0020790", "N0000000235", "N0000185503"], "unii": ["459384H98V"], "rxcui": ["403967"], "spl_set_id": ["994e3ce0-f30b-47b1-aa42-b1ed37fb7c12"], "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": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 POUCH in 1 BOX (70518-4349-0)  / 1 CAPSULE in 1 POUCH (70518-4349-1)", "package_ndc": "70518-4349-0", "marketing_start_date": "20250530"}], "brand_name": "Zonisamide", "product_id": "70518-4349_365be0d1-cb8d-861b-e063-6294a90a9d8b", "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": "70518-4349", "generic_name": "Zonisamide", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zonisamide", "active_ingredients": [{"name": "ZONISAMIDE", "strength": "50 mg/1"}], "application_number": "ANDA077645", "marketing_category": "ANDA", "marketing_start_date": "20250530", "listing_expiration_date": "20261231"}