zonisamide

Generic: zonisamide

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zonisamide
Generic Name zonisamide
Labeler glenmark pharmaceuticals inc., usa
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

zonisamide 50 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-129
Product ID 68462-129_c00ccc2d-52c6-4a11-a310-d8db25ca3928
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077651
Listing Expiration 2026-12-31
Marketing Start 2006-01-30

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 68462129
Hyphenated Format 68462-129

Supplemental Identifiers

RxCUI
314285 403966 403967
UPC
0368462130018 0368462129012 0368462128015
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 ANDA077651 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68462-129-01)
  • 500 CAPSULE in 1 BOTTLE (68462-129-05)
source: ndc

Packages (2)

68462-129-01 100 CAPSULE in 1 BOTTLE (68462-129-01) 68462-129-05 500 CAPSULE in 1 BOTTLE (68462-129-05)

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": "c00ccc2d-52c6-4a11-a310-d8db25ca3928", "openfda": {"nui": ["N0000175753", "N0000008486", "M0020790", "N0000000235", "N0000185503"], "upc": ["0368462130018", "0368462129012", "0368462128015"], "unii": ["459384H98V"], "rxcui": ["314285", "403966", "403967"], "spl_set_id": ["fe15e56e-8b86-4a65-825c-31d37dd81612"], "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": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68462-129-01)", "package_ndc": "68462-129-01", "marketing_start_date": "20060130"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (68462-129-05)", "package_ndc": "68462-129-05", "marketing_start_date": "20060130"}], "brand_name": "Zonisamide", "product_id": "68462-129_c00ccc2d-52c6-4a11-a310-d8db25ca3928", "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": "68462-129", "generic_name": "Zonisamide", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zonisamide", "active_ingredients": [{"name": "ZONISAMIDE", "strength": "50 mg/1"}], "application_number": "ANDA077651", "marketing_category": "ANDA", "marketing_start_date": "20060130", "listing_expiration_date": "20261231"}