FDA.reportPublic FDA data

Zonisamide

Product NDC
71335-9679
11-digit product format
713359679
Labeler code
71335
Product ID
71335-9679_22af5ef5-8818-47b2-b0fa-f1401aa89e75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214492
Marketing category
ANDA
Marketing start
2021-07-09
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
71335-9679-1Zonisamide100 in 1 BOTTLECAPSULE100100
71335-9679-2Zonisamide90 in 1 BOTTLECAPSULE90100
71335-9679-3Zonisamide30 in 1 BOTTLECAPSULE30100
71335-9679-4Zonisamide60 in 1 BOTTLECAPSULE60100
71335-9679-5Zonisamide120 in 1 BOTTLECAPSULE120100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9679ZONISAMIDE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 5 package rows20230407_2d569c8a-844b-44a8-81df-3f9c9300a79c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314285zonisamide 100 MG Oral CapsulePSN2d569c8a-844b-44a8-81df-3f9c9300a79c100
314285zonisamide 100 MG Oral CapsuleSCD2d569c8a-844b-44a8-81df-3f9c9300a79c100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9679-171335967901100 CAPSULE in 1 BOTTLE (71335-9679-1) 100 capsule2023-04-06NoNoCurrent
71335-9679-27133596790290 CAPSULE in 1 BOTTLE (71335-9679-2) 90 capsule2023-04-06NoNoCurrent
71335-9679-37133596790330 CAPSULE in 1 BOTTLE (71335-9679-3) 30 capsule2023-04-06NoNoCurrent
71335-9679-47133596790460 CAPSULE in 1 BOTTLE (71335-9679-4) 60 capsule2023-04-06NoNoCurrent
71335-9679-571335967905120 CAPSULE in 1 BOTTLE (71335-9679-5) 120 capsule2023-04-06NoNoCurrent