FDA.reportPublic FDA data

ZONISADE

Product NDC
52652-8001
11-digit product format
526528001
Labeler code
52652
Product ID
52652-8001_063fd04f-90bf-4b1f-99fe-4e2cdb5b1eea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ZONISAMIDE
Dosage form
SUSPENSION
Route
ORAL
Labeler
Azurity Pharmaceuticals, Inc.
Application
NDA214273
Marketing category
NDA
Marketing start
2022-07-15
Substance
ZONISAMIDE
Active strength
100 mg/5mL
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
ZONISADE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZONISAMIDE100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii459384H98V
Rxcui2606782, 2606788

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
52652-8001-1ZONISADE1 in 1 CARTONSUSPENSION13
52652-8001-1ZONISADE150 mL in 1 BOTTLESUSPENSION1503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52652-8001-1ML - Milliliter52652-80016e84684b-887a-4ae3-bdd0-90b697d24c9112022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52652-8001ZONISADE (ZONISAMIDE) SUSPENSION [AZURITY PHRAMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20230615_ac16fa15-32e9-4f92-8bc6-d8d41ae002c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2606788ZONISADE 100 MG in 5 mL Oral SuspensionPSNac16fa15-32e9-4f92-8bc6-d8d41ae002c63
2606782zonisamide 100 MG in 5 mL Oral SuspensionPSNac16fa15-32e9-4f92-8bc6-d8d41ae002c63
2606788zonisamide 20 MG/ML Oral Suspension [Zonisade]SBDac16fa15-32e9-4f92-8bc6-d8d41ae002c63
2606782zonisamide 20 MG/ML Oral SuspensionSCDac16fa15-32e9-4f92-8bc6-d8d41ae002c63
2606788Zonisade 100 MG per 5 ML Oral SuspensionSYac16fa15-32e9-4f92-8bc6-d8d41ae002c63
2606788Zonisade 20 MG/ML Oral SuspensionSYac16fa15-32e9-4f92-8bc6-d8d41ae002c63
2606782zonisamide 100 MG per 5 ML Oral SuspensionSYac16fa15-32e9-4f92-8bc6-d8d41ae002c63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52652-8001-1526528001011 BOTTLE in 1 CARTON (52652-8001-1) / 150 mL in 1 BOTTLE1 bottle2022-07-150000-00-00NoNoCurrent