FDA.reportPublic FDA data

Zonisamide

Product NDC
50268-816
11-digit product format
502680816
Labeler code
50268
Product ID
50268-816_41ac7d6a-8113-6e97-e063-6394a90a088b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA077869
Marketing category
ANDA
Marketing start
2014-07-02
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
50268-816-11Zonisamide1 in 1 BLISTER PACKCAPSULE110
50268-816-15Zonisamide50 in 1 BOXCAPSULE5010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-816-11EA - Each50268-8160e187df4-bf59-49b1-86fa-2f871edeb38f12015-05-05
50268-816-15EA - Each50268-8167f022a70-20d4-440e-91b9-d1bdf2a7015512014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZONISAMIDEACTIVE INGREDIENT459384H98VZONISAMIDE CAPSULE [AVPAK]2
ZONISAMIDEACTIVE MOIETY459384H98VZONISAMIDE CAPSULE [AVPAK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZONISAMIDE CAPSULE [AVPAK]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZONISAMIDE CAPSULE [AVPAK]2
GELATININACTIVE INGREDIENT2G86QN327LZONISAMIDE CAPSULE [AVPAK]2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYZONISAMIDE CAPSULE [AVPAK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZONISAMIDE CAPSULE [AVPAK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-816ZONISAMIDE CAPSULE [AVPAK]9Current NDC, Legacy NDC, 2 package rows20250112_b20a51ef-255e-1eb0-c0e1-461cde46b887.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314285zonisamide 100 MG Oral CapsulePSNb20a51ef-255e-1eb0-c0e1-461cde46b88710
314285zonisamide 100 MG Oral CapsuleSCDb20a51ef-255e-1eb0-c0e1-461cde46b88710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-816-11502680816111 in 1 BLISTER PACKHistorical
50268-816-155026808161550 BLISTER PACK in 1 BOX (50268-816-15) / 1 CAPSULE in 1 BLISTER PACK (50268-816-11) 50 blister pack2014-07-020000-00-00NoNoCurrent