zonisamide

Product NDC
71335-0486
11-digit product format
713350486
Labeler code
71335
Product ID
71335-0486_e2e2bffc-45ca-42a8-ae95-2a14dd6182b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077869
Marketing category
ANDA
Marketing start
2016-07-13
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
71335-0486-1zonisamide100 in 1 BOTTLECAPSULE1005
71335-0486-2zonisamide90 in 1 BOTTLECAPSULE905
71335-0486-3zonisamide30 in 1 BOTTLECAPSULE305
71335-0486-4zonisamide60 in 1 BOTTLECAPSULE605
71335-0486-5zonisamide120 in 1 BOTTLECAPSULE1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0486ZONISAMIDE CAPSULE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 5 package rows20231025_64bd9d6f-8cc0-4151-a78d-9f1437b36875.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314285zonisamide 100 MG Oral CapsulePSN64bd9d6f-8cc0-4151-a78d-9f1437b368755
314285zonisamide 100 MG Oral CapsuleSCD64bd9d6f-8cc0-4151-a78d-9f1437b368755

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0486-171335048601100 CAPSULE in 1 BOTTLE (71335-0486-1) 100 capsule2021-12-270000-00-00NoNoCurrent
71335-0486-27133504860290 CAPSULE in 1 BOTTLE (71335-0486-2) 90 capsule2021-12-270000-00-00NoNoCurrent
71335-0486-37133504860330 CAPSULE in 1 BOTTLE (71335-0486-3) 30 capsule2021-12-270000-00-00NoNoCurrent
71335-0486-47133504860460 CAPSULE in 1 BOTTLE (71335-0486-4) 60 capsule2021-12-270000-00-00NoNoCurrent
71335-0486-571335048605120 CAPSULE in 1 BOTTLE (71335-0486-5) 120 capsule2021-12-270000-00-00NoNoCurrent