Zonisamide

Product NDC
72189-374
11-digit product format
721890374
Labeler code
72189
Product ID
72189-374_2c4cbd73-cdad-14f5-e063-6294a90ab38e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA077634
Marketing category
ANDA
Marketing start
2022-08-15
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
72189-374-72Zonisamide120 in 1 BOTTLECAPSULE1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-374-72EA - Each72189-374919f65bc-d217-455d-a2ad-150f641aba3e12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-374ZONISAMIDE CAPSULE [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20250123_e64b78d8-79de-337b-e053-2a95a90a4861.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403966zonisamide 25 MG Oral CapsulePSNe64b78d8-79de-337b-e053-2a95a90a48612
403966zonisamide 25 MG Oral CapsuleSCDe64b78d8-79de-337b-e053-2a95a90a48612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-374-7272189037472120 CAPSULE in 1 BOTTLE (72189-374-72) 120 capsule2022-08-150000-00-00NoNoCurrent