FDA.reportPublic FDA data

Zonisamide

Product NDC
71335-2797
11-digit product format
713352797
Labeler code
71335
Product ID
71335-2797_cbac05d2-890e-47ff-a2b6-b9b939627c10
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
100 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
ZONISAMIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii459384H98V
Rxcui314285

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
71335-2797-1Zonisamide100 in 1 BOTTLECAPSULE1001
71335-2797-2Zonisamide90 in 1 BOTTLECAPSULE901
71335-2797-3Zonisamide30 in 1 BOTTLECAPSULE301
71335-2797-4Zonisamide60 in 1 BOTTLECAPSULE601
71335-2797-5Zonisamide120 in 1 BOTTLECAPSULE1201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314285zonisamide 100 MG Oral CapsulePSN5000f95c-c78d-4150-9a69-0ee2943cf2c31
314285zonisamide 100 MG Oral CapsuleSCD5000f95c-c78d-4150-9a69-0ee2943cf2c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2797-171335279701100 CAPSULE in 1 BOTTLE (71335-2797-1) 100 capsule2025-10-13NoNoCurrent
71335-2797-27133527970290 CAPSULE in 1 BOTTLE (71335-2797-2) 90 capsule2025-10-13NoNoCurrent
71335-2797-37133527970330 CAPSULE in 1 BOTTLE (71335-2797-3) 30 capsule2025-10-13NoNoCurrent
71335-2797-47133527970460 CAPSULE in 1 BOTTLE (71335-2797-4) 60 capsule2025-10-13NoNoCurrent
71335-2797-571335279705120 CAPSULE in 1 BOTTLE (71335-2797-5) 120 capsule2025-10-13NoNoCurrent