FDA.reportPublic FDA data

Zonisamide

Product NDC
71335-2798
11-digit product format
713352798
Labeler code
71335
Product ID
71335-2798_b17adb6b-9471-4383-a843-fb9cf4415246
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077651
Marketing category
ANDA
Marketing start
2006-01-30
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
71335-2798-1Zonisamide60 in 1 BOTTLECAPSULE602
71335-2798-2Zonisamide90 in 1 BOTTLECAPSULE902
71335-2798-3Zonisamide30 in 1 BOTTLECAPSULE302
71335-2798-4Zonisamide70 in 1 BOTTLECAPSULE702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2798-2EA - Each71335-279864755db2-056c-4e7a-98b5-75e1832b21be12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403966zonisamide 25 MG Oral CapsulePSN1a859304-804a-4588-9961-c2e6ae09aadb2
403966zonisamide 25 MG Oral CapsuleSCD1a859304-804a-4588-9961-c2e6ae09aadb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2798-17133527980160 CAPSULE in 1 BOTTLE (71335-2798-1) 60 capsule2025-10-13NoNoHistorical
71335-2798-27133527980290 CAPSULE in 1 BOTTLE (71335-2798-2) 90 capsule2025-10-13NoNoHistorical
71335-2798-37133527980330 CAPSULE in 1 BOTTLE (71335-2798-3) 30 capsule2025-10-13NoNoHistorical
71335-2798-47133527980470 CAPSULE in 1 BOTTLE (71335-2798-4) 70 capsule2025-10-13NoNoHistorical