Zonisamide

Product NDC
72189-624
11-digit product format
721890624
Labeler code
72189
Product ID
72189-624_35bcaee1-0020-82da-e063-6394a90a4a0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA077625
Marketing category
ANDA
Marketing start
2025-05-22
Substance
ZONISAMIDE
Active strength
25 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zonisamide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZONISAMIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii459384H98V
Rxcui403966

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ca446c7-87bf-4d4c-9a5f-4c587ab0290fProduct name120230316
c27132c2-a1b9-fc49-b84e-22e55312d19eProduct name220210621

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-624-72Zonisamide120 in 1 BOTTLECAPSULE1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-624ZONISAMIDE CAPSULE [DIRECT_RX]1Current NDC, 1 package rows20250524_35bcaee1-001f-82da-e063-6394a90a4a0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403966zonisamide 25 MG Oral CapsulePSN35bcaee1-001f-82da-e063-6394a90a4a0f1
403966zonisamide 25 MG Oral CapsuleSCD35bcaee1-001f-82da-e063-6394a90a4a0f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-624-7272189062472120 CAPSULE in 1 BOTTLE (72189-624-72) 120 capsule2025-05-22NoNoCurrent