FDA.reportPublic FDA data

ZONISAMIDE

Product NDC
61919-775
11-digit product format
619190775
Labeler code
61919
Product ID
61919-775_ca4069e7-85af-56d3-e053-2a95a90a0227
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ZONISAMIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA077651
Marketing category
ANDA
Marketing start
2019-08-13
Marketing end
0000-00-00
Substance
ZONISAMIDE
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ca446c7-87bf-4d4c-9a5f-4c587ab0290fProduct name120230316
c27132c2-a1b9-fc49-b84e-22e55312d19eProduct name220210621

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-775-302023-01-30C16284748780-1f386c649-99d5-0266-e053-dadaa90a7c1aZONISAMIDE
61919-775-902023-01-30C16284748780-1f386c649-99d5-0266-e053-dadaa90a7c1aZONISAMIDE
61919-775-602020-01-31C16284748780-19d75b9d0-cf85-f424-e053-dadaa90a57ceZonisamide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-775-30ZONISAMIDE30 in 1 BOTTLECAPSULE303
61919-775-90ZONISAMIDE90 in 1 BOTTLECAPSULE903
61919-775-60Zonisamide60 in 1 BOTTLECAPSULE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-775ZONISAMIDE CAPSULE [DIRECT_RX]3Legacy NDC, 2 package rows20210824_9001965b-dbf6-5504-e053-2a95a90a3c43.zip
61919-775ZONISAMIDE CAPSULE [DIRECT RX]2Legacy NDC, 1 package rows20160923_94c92836-8673-417a-b461-5b3e68c95b5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314285zonisamide 100 MG Oral CapsulePSN9001965b-dbf6-5504-e053-2a95a90a3c433
314285zonisamide 100 MG Oral CapsuleSCD9001965b-dbf6-5504-e053-2a95a90a3c433
314285zonisamide 100 MG Oral CapsulePSN94c92836-8673-417a-b461-5b3e68c95b5e2
314285zonisamide 100 MG Oral CapsuleSCD94c92836-8673-417a-b461-5b3e68c95b5e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-775-306191907753030 CAPSULE in 1 BOTTLE (61919-775-30) 30 capsule2019-08-130000-00-00NoNoCurrent
61919-775-606191907756060 in 1 BOTTLEHistorical
61919-775-906191907759090 CAPSULE in 1 BOTTLE (61919-775-90) 90 capsule2019-08-130000-00-00NoNoCurrent