FDA.reportPublic FDA data

ZONISAMIDE

Product NDC
61919-917
11-digit product format
619190917
Labeler code
61919
Product ID
61919-917_e93413f9-dfe8-1b5e-e053-2995a90a2b27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ZONISAMIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA077634
Marketing category
ANDA
Marketing start
2019-08-19
Marketing end
0000-00-00
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
2023-12-31
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
61919-917-302026-01-29C16284748780-149896155-c8f8-586f-e063-e6dba90add90ZONISAMIDE
61919-917-902026-01-29C16284748780-149896155-c8f8-586f-e063-e6dba90add90ZONISAMIDE
61919-917-602020-01-31C16284748780-19d75b9d0-9a7b-f424-e053-dadaa90a57ceZONISAMIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-917-30ZONISAMIDE30 in 1 BOTTLECAPSULE305
61919-917-90ZONISAMIDE90 in 1 BOTTLECAPSULE905
61919-917-60ZONISAMIDE60 in 1 BOTTLECAPSULE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-917-30EA - Each61919-9173d16dd96-c7e7-4310-a25c-54cd0d549fc112019-09-05
61919-917-60EA - Each61919-9173f86510c-ac2c-4f57-9c00-818ed1b0d17d12017-12-14
61919-917-90EA - Each61919-917d2292fcb-fe52-4d46-95c9-6c71c4353ec312022-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZONISAMIDEACTIVE INGREDIENT459384H98VZONISAMIDE CAPSULE [DIRECT RX]3
ZONISAMIDEACTIVE MOIETY459384H98VZONISAMIDE CAPSULE [DIRECT RX]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZONISAMIDE CAPSULE [DIRECT RX]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZONISAMIDE CAPSULE [DIRECT RX]3
GELATININACTIVE INGREDIENT2G86QN327LZONISAMIDE CAPSULE [DIRECT RX]3
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYZONISAMIDE CAPSULE [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZONISAMIDE CAPSULE [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-917ZONISAMIDE CAPSULE [DIRECT_RX]5Legacy NDC, 2 package rows20240111_907c965e-8faf-53db-e053-2995a90a8cd1.zip
61919-917ZONISAMIDE CAPSULE [DIRECT RX]4Legacy NDC, 1 package rows20171111_31b97f07-9783-479d-b448-b272610a2f36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314285zonisamide 100 MG Oral CapsulePSN907c965e-8faf-53db-e053-2995a90a8cd15
314285zonisamide 100 MG Oral CapsuleSCD907c965e-8faf-53db-e053-2995a90a8cd15
314285zonisamide 100 MG Oral CapsulePSN31b97f07-9783-479d-b448-b272610a2f364
314285zonisamide 100 MG Oral CapsuleSCD31b97f07-9783-479d-b448-b272610a2f364

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-917-306191909173030 CAPSULE in 1 BOTTLE (61919-917-30) 30 capsule2019-08-190000-00-00NoNoCurrent
61919-917-606191909176060 in 1 BOTTLEHistorical
61919-917-906191909179090 CAPSULE in 1 BOTTLE (61919-917-90) 90 capsule2022-09-210000-00-00NoNoCurrent