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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-775-30EA - Each61919-775e811d695-11ca-4f4c-ae67-160d28d26c8812021-09-07
61919-775-60EA - Each61919-7751f71d95f-e592-4e86-b4c2-497cca798d2012016-09-02
61919-775-90EA - Each61919-775948df912-2703-4b81-9b5f-8da04dabbf9f12019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZONISAMIDEACTIVE INGREDIENT459384H98VDIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]1
ZONISAMIDEACTIVE MOIETY459384H98VDIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LDIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]1
SHELLACINACTIVE INGREDIENT46N107B71ODIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX]1

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