Zonisamide

Product NDC
60687-230
11-digit product format
606870230
Labeler code
60687
Product ID
60687-230_19ad0290-7bfe-df6f-e063-6394a90a8390
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077869
Marketing category
ANDA
Marketing start
2016-11-15
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
60687-230-01Zonisamide100 in 1 BOX, UNIT-DOSECAPSULE1008
60687-230-11Zonisamide1 in 1 BLISTER PACKCAPSULE18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-230-01EA - Each60687-2304b7ed7c2-b718-45be-9f36-25c67076fd6d12018-09-05
60687-230-11EA - Each60687-23059862460-5ea1-40fe-aca6-45fdcee6b48c12017-03-06
60687-230-65EA - Each60687-230a1774d96-f289-4c5a-8de8-e4a865f2e48b12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-230ZONISAMIDE CAPSULE [AMERICAN HEALTH PACKAGING]8Current NDC, Legacy NDC, 2 package rows20240709_7cdd96c4-3263-4c28-86c0-3c24bcef16c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314285zonisamide 100 MG Oral CapsulePSN7cdd96c4-3263-4c28-86c0-3c24bcef16c18
314285zonisamide 100 MG Oral CapsuleSCD7cdd96c4-3263-4c28-86c0-3c24bcef16c18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-230-0160687023001100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-230-01) / 1 CAPSULE in 1 BLISTER PACK (60687-230-11) 100 blister pack2018-08-140000-00-00NoNoCurrent
60687-230-11606870230111 in 1 BLISTER PACKHistorical