NDC 53217-301

zonisamide

Zonisamide

zonisamide is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Zonisamide.

Product ID53217-301_325e0a60-3a47-422a-a504-b445a426a2c9
NDC53217-301
Product TypeHuman Prescription Drug
Proprietary Namezonisamide
Generic NameZonisamide
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-07-13
Marketing CategoryANDA / ANDA
Application NumberANDA077869
Labeler NameAidarex Pharmaceuticals LLC
Substance NameZONISAMIDE
Active Ingredient Strength100 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53217-301-90

90 CAPSULE in 1 BOTTLE (53217-301-90)
Marketing Start Date2016-07-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53217-301-60 [53217030160]

zonisamide CAPSULE
Marketing CategoryANDA
Application NumberANDA077869
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-13
Inactivation Date2020-01-31

NDC 53217-301-90 [53217030190]

zonisamide CAPSULE
Marketing CategoryANDA
Application NumberANDA077869
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-13
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ZONISAMIDE100 mg/1

OpenFDA Data

SPL SET ID:66c509ab-ecf3-48ff-bb6d-97989f3b747b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314285
  • Pharmacological Class

    • Decreased Central Nervous System Disorganized Electrical Activity [PE]
    • Anti-epileptic Agent [EPC]
    • Sulfonamides [CS]
    • Carbonic Anhydrase Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]

    NDC Crossover Matching brand name "zonisamide" or generic name "Zonisamide"

    NDCBrand NameGeneric Name
    0185-0193ZonisamideZonisamide
    0185-0199ZonisamideZonisamide
    0185-0200ZonisamideZonisamide
    0378-6725Zonisamidezonisamide
    0378-6726Zonisamidezonisamide
    0378-6727Zonisamidezonisamide
    0615-1379Zonisamidezonisamide
    0615-8266zonisamidezonisamide
    21695-155ZONISAMIDEZONISAMIDE
    21695-654ZONISAMIDEZONISAMIDE
    29300-428ZonisamideZonisamide
    29300-429ZonisamideZonisamide
    29300-430ZonisamideZonisamide
    31722-228ZonisamideZonisamide
    33261-843ZONISAMIDEZONISAMIDE
    35356-143ZONISAMIDEZONISAMIDE
    43063-575Zonisamidezonisamide
    43063-932ZonisamideZonisamide
    50090-2174ZonisamideZonisamide
    50268-816ZonisamideZonisamide
    51079-768Zonisamidezonisamide
    51407-137ZonisamideZonisamide
    51407-138ZonisamideZonisamide
    68001-243ZonisamideZonisamide
    68001-242ZonisamideZonisamide
    68001-244ZonisamideZonisamide
    68071-4152ZonisamideZonisamide
    68382-213ZonisamideZonisamide
    68382-212ZonisamideZonisamide
    68382-214ZonisamideZonisamide
    68462-130ZonisamideZonisamide
    68462-129ZonisamideZonisamide
    68462-128ZonisamideZonisamide
    69097-861zonisamidezonisamide
    70518-1701ZonisamideZonisamide
    70771-1142ZonisamideZonisamide
    70771-1144ZonisamideZonisamide
    70771-1143ZonisamideZonisamide
    71335-0486zonisamidezonisamide
    71335-0962ZonisamideZonisamide
    71335-0125ZonisamideZonisamide
    76282-228ZonisamideZonisamide
    51407-139ZonisamideZonisamide
    53217-301zonisamidezonisamide
    55111-288ZonisamideZonisamide
    55111-402ZonisamideZonisamide
    55111-403ZonisamideZonisamide
    55648-990ZONISAMIDEZONISAMIDE
    55648-946ZONISAMIDEZONISAMIDE
    55648-945ZONISAMIDEZONISAMIDE

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.