zonisamide

Product NDC
0615-8266
11-digit product format
006158266
Labeler code
0615
Product ID
0615-8266_994eb4b5-f6d8-442c-88a2-5fd6ec8ca762
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
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
0615-8266-39zonisamide30 in 1 BLISTER PACKCAPSULE308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8266ZONISAMIDE CAPSULE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]8Current NDC, Legacy NDC, 1 package rows20241204_226d917a-33de-48cc-baf6-bd6a20668341.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314285zonisamide 100 MG Oral CapsulePSN226d917a-33de-48cc-baf6-bd6a206683418
314285zonisamide 100 MG Oral CapsuleSCD226d917a-33de-48cc-baf6-bd6a206683418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8266-390061582663930 CAPSULE in 1 BLISTER PACK (0615-8266-39) 30 capsule2019-01-100000-00-00NoNoCurrent