zonisamide

Generic: zonisamide

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zonisamide
Generic Name zonisamide
Labeler bryant ranch prepack
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

zonisamide 100 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-0486
Product ID 71335-0486_e2e2bffc-45ca-42a8-ae95-2a14dd6182b5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077869
Listing Expiration 2026-12-31
Marketing Start 2016-07-13

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 713350486
Hyphenated Format 71335-0486

Supplemental Identifiers

RxCUI
314285
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 ANDA077869 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (71335-0486-1)
  • 90 CAPSULE in 1 BOTTLE (71335-0486-2)
  • 30 CAPSULE in 1 BOTTLE (71335-0486-3)
  • 60 CAPSULE in 1 BOTTLE (71335-0486-4)
  • 120 CAPSULE in 1 BOTTLE (71335-0486-5)
source: ndc

Packages (5)

71335-0486-1 100 CAPSULE in 1 BOTTLE (71335-0486-1) 71335-0486-2 90 CAPSULE in 1 BOTTLE (71335-0486-2) 71335-0486-3 30 CAPSULE in 1 BOTTLE (71335-0486-3) 71335-0486-4 60 CAPSULE in 1 BOTTLE (71335-0486-4) 71335-0486-5 120 CAPSULE in 1 BOTTLE (71335-0486-5)

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": "e2e2bffc-45ca-42a8-ae95-2a14dd6182b5", "openfda": {"nui": ["N0000175753", "N0000008486", "M0020790", "N0000000235", "N0000185503"], "unii": ["459384H98V"], "rxcui": ["314285"], "spl_set_id": ["64bd9d6f-8cc0-4151-a78d-9f1437b36875"], "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": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (71335-0486-1)", "package_ndc": "71335-0486-1", "marketing_start_date": "20211227"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71335-0486-2)", "package_ndc": "71335-0486-2", "marketing_start_date": "20211227"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71335-0486-3)", "package_ndc": "71335-0486-3", "marketing_start_date": "20211227"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71335-0486-4)", "package_ndc": "71335-0486-4", "marketing_start_date": "20211227"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (71335-0486-5)", "package_ndc": "71335-0486-5", "marketing_start_date": "20211227"}], "brand_name": "zonisamide", "product_id": "71335-0486_e2e2bffc-45ca-42a8-ae95-2a14dd6182b5", "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": "71335-0486", "generic_name": "zonisamide", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "zonisamide", "active_ingredients": [{"name": "ZONISAMIDE", "strength": "100 mg/1"}], "application_number": "ANDA077869", "marketing_category": "ANDA", "marketing_start_date": "20160713", "listing_expiration_date": "20261231"}