Zonegran

Product NDC
59212-680
11-digit product format
592120680
Labeler code
59212
Product ID
59212-680_e3848741-066e-4ee2-bf13-0b4c1d32b3c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanz Pharma (US) Corp.
Application
NDA020789
Marketing category
NDA
Marketing start
2000-03-27
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
Zonegran
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZONISAMIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii459384H98V
Rxcui284408, 314285, 403966, 404725

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
59212-680-10Zonegran100 in 1 BOTTLECAPSULE10012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59212-680ZONEGRAN (ZONISAMIDE) CAPSULE [ADVANZ PHARMA (US) CORP.]11Current NDC, Legacy NDC, 1 package rows20241224_d12de43e-3ac3-4335-bc85-70d7366a91eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284408Zonegran 100 MG Oral CapsulePSNd12de43e-3ac3-4335-bc85-70d7366a91eb12
404725Zonegran 25 MG Oral CapsulePSNd12de43e-3ac3-4335-bc85-70d7366a91eb12
314285zonisamide 100 MG Oral CapsulePSNd12de43e-3ac3-4335-bc85-70d7366a91eb12
403966zonisamide 25 MG Oral CapsulePSNd12de43e-3ac3-4335-bc85-70d7366a91eb12
284408zonisamide 100 MG Oral Capsule [Zonegran]SBDd12de43e-3ac3-4335-bc85-70d7366a91eb12
404725zonisamide 25 MG Oral Capsule [Zonegran]SBDd12de43e-3ac3-4335-bc85-70d7366a91eb12
314285zonisamide 100 MG Oral CapsuleSCDd12de43e-3ac3-4335-bc85-70d7366a91eb12
403966zonisamide 25 MG Oral CapsuleSCDd12de43e-3ac3-4335-bc85-70d7366a91eb12
284408Zonegran 100 MG Oral CapsuleSYd12de43e-3ac3-4335-bc85-70d7366a91eb12
404725Zonegran 25 MG Oral CapsuleSYd12de43e-3ac3-4335-bc85-70d7366a91eb12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59212-680-1059212068010100 CAPSULE in 1 BOTTLE (59212-680-10) 100 capsule2000-03-270000-00-00NoNoCurrent