zonisamide

Generic: zonisamide

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zonisamide
Generic Name zonisamide
Labeler sun pharmaceutical industries, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

zonisamide 50 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-259
Product ID 62756-259_d0c9002b-fa32-4ca8-862f-5286746df2cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077634
Listing Expiration 2026-12-31
Marketing Start 2006-03-17

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 62756259
Hyphenated Format 62756-259

Supplemental Identifiers

RxCUI
314285 403966 403967
UPC
0362756260016 0362756259010 0362756258013
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 ANDA077634 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (62756-259-01)
  • 100 CAPSULE in 1 BOTTLE (62756-259-02)
  • 100 CAPSULE in 1 BOTTLE (62756-259-03)
  • 1000 CAPSULE in 1 BOTTLE (62756-259-04)
source: ndc

Packages (4)

62756-259-01 30 CAPSULE in 1 BOTTLE (62756-259-01) 62756-259-02 100 CAPSULE in 1 BOTTLE (62756-259-02) 62756-259-03 100 CAPSULE in 1 BOTTLE (62756-259-03) 62756-259-04 1000 CAPSULE in 1 BOTTLE (62756-259-04)

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": "d0c9002b-fa32-4ca8-862f-5286746df2cb", "openfda": {"nui": ["N0000175753", "N0000008486", "M0020790", "N0000000235", "N0000185503"], "upc": ["0362756260016", "0362756259010", "0362756258013"], "unii": ["459384H98V"], "rxcui": ["314285", "403966", "403967"], "spl_set_id": ["3164d438-90bf-420a-9a56-5498b987f91c"], "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": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (62756-259-01)", "package_ndc": "62756-259-01", "marketing_start_date": "20060317"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (62756-259-02)", "package_ndc": "62756-259-02", "marketing_start_date": "20060317"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (62756-259-03)", "package_ndc": "62756-259-03", "marketing_start_date": "20060317"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (62756-259-04)", "package_ndc": "62756-259-04", "marketing_start_date": "20060317"}], "brand_name": "Zonisamide", "product_id": "62756-259_d0c9002b-fa32-4ca8-862f-5286746df2cb", "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": "62756-259", "generic_name": "Zonisamide", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zonisamide", "active_ingredients": [{"name": "ZONISAMIDE", "strength": "50 mg/1"}], "application_number": "ANDA077634", "marketing_category": "ANDA", "marketing_start_date": "20060317", "listing_expiration_date": "20261231"}