zonisamide

Generic: zonisamide

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zonisamide
Generic Name zonisamide
Labeler aurobindo pharma limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

zonisamide 100 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-380
Product ID 59651-380_b43ac632-68f3-43f6-aa79-41429a54e1ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077645
Listing Expiration 2027-12-31
Marketing Start 2020-08-17

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 59651380
Hyphenated Format 59651-380

Supplemental Identifiers

RxCUI
314285 403966 403967
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 ANDA077645 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (59651-380-01)
  • 30 CAPSULE in 1 BOTTLE (59651-380-03)
  • 500 CAPSULE in 1 BOTTLE (59651-380-05)
  • 60 CAPSULE in 1 BOTTLE (59651-380-60)
source: ndc

Packages (4)

59651-380-01 100 CAPSULE in 1 BOTTLE (59651-380-01) 59651-380-03 30 CAPSULE in 1 BOTTLE (59651-380-03) 59651-380-05 500 CAPSULE in 1 BOTTLE (59651-380-05) 59651-380-60 60 CAPSULE in 1 BOTTLE (59651-380-60)

Ingredients (1)

zonisamide (100 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": "b43ac632-68f3-43f6-aa79-41429a54e1ef", "openfda": {"nui": ["N0000175753", "N0000008486", "M0020790", "N0000000235", "N0000185503"], "unii": ["459384H98V"], "rxcui": ["314285", "403966", "403967"], "spl_set_id": ["ab0631ca-5339-4570-bc27-f1dd92de1d6f"], "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": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (59651-380-01)", "package_ndc": "59651-380-01", "marketing_start_date": "20200817"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (59651-380-03)", "package_ndc": "59651-380-03", "marketing_start_date": "20200817"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (59651-380-05)", "package_ndc": "59651-380-05", "marketing_start_date": "20200817"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (59651-380-60)", "package_ndc": "59651-380-60", "marketing_start_date": "20200817"}], "brand_name": "Zonisamide", "product_id": "59651-380_b43ac632-68f3-43f6-aa79-41429a54e1ef", "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": "59651-380", "generic_name": "Zonisamide", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zonisamide", "active_ingredients": [{"name": "ZONISAMIDE", "strength": "100 mg/1"}], "application_number": "ANDA077645", "marketing_category": "ANDA", "marketing_start_date": "20200817", "listing_expiration_date": "20271231"}