Zonisamide

Product NDC
71335-2796
11-digit product format
713352796
Labeler code
71335
Product ID
71335-2796_94aeaba7-6c30-45d2-9dce-0b4fd4f3feb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077625
Marketing category
ANDA
Marketing start
2022-07-04
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
71335-2796-1Zonisamide60 in 1 BOTTLECAPSULE601
71335-2796-2Zonisamide90 in 1 BOTTLECAPSULE901
71335-2796-3Zonisamide30 in 1 BOTTLECAPSULE301
71335-2796-4Zonisamide70 in 1 BOTTLECAPSULE701

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403966zonisamide 25 MG Oral CapsulePSN33b84aaa-044d-4c15-bb21-d1ce8674eec91
403966zonisamide 25 MG Oral CapsuleSCD33b84aaa-044d-4c15-bb21-d1ce8674eec91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2796-17133527960160 CAPSULE in 1 BOTTLE (71335-2796-1) 60 capsule2025-10-13NoNoCurrent
71335-2796-27133527960290 CAPSULE in 1 BOTTLE (71335-2796-2) 90 capsule2025-10-13NoNoCurrent
71335-2796-37133527960330 CAPSULE in 1 BOTTLE (71335-2796-3) 30 capsule2025-10-13NoNoCurrent
71335-2796-47133527960470 CAPSULE in 1 BOTTLE (71335-2796-4) 70 capsule2025-10-13NoNoCurrent