ZONISAMIDE

Product NDC
55648-946
11-digit product format
556480946
Labeler code
55648
Product ID
55648-946_bcc27cd7-e3ac-4ec3-ba94-7bcaaf9bcf10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ZONISAMIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
WOCKHARDT LIMITED
Application
ANDA077636
Marketing category
ANDA
Marketing start
2006-07-27
Marketing end
0000-00-00
Substance
ZONISAMIDE
Active strength
50 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
E
Listing certified through
2017-12-31
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
55648-946-012019-10-29C16284748780-1960f7f55-cdc1-8e05-e053-dbdaa90a074aProduct Information Zonisamide Capsules Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-946-01ZONISAMIDE100 in 1 BOTTLECAPSULE1001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZONISAMIDEACTIVE INGREDIENT459384H98VZONISAMIDE CAPSULE [WOCKHARDT LIMITED]1
ZONISAMIDEACTIVE MOIETY459384H98VZONISAMIDE CAPSULE [WOCKHARDT LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZONISAMIDE CAPSULE [WOCKHARDT LIMITED]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHZONISAMIDE CAPSULE [WOCKHARDT LIMITED]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GZONISAMIDE CAPSULE [WOCKHARDT LIMITED]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZONISAMIDE CAPSULE [WOCKHARDT LIMITED]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZONISAMIDE CAPSULE [WOCKHARDT LIMITED]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MZONISAMIDE CAPSULE [WOCKHARDT LIMITED]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ZONISAMIDE CAPSULE [WOCKHARDT LIMITED]1
GELATININACTIVE INGREDIENT2G86QN327LZONISAMIDE CAPSULE [WOCKHARDT LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZONISAMIDE CAPSULE [WOCKHARDT LIMITED]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JZONISAMIDE CAPSULE [WOCKHARDT LIMITED]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZONISAMIDE CAPSULE [WOCKHARDT LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UZONISAMIDE CAPSULE [WOCKHARDT LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZONISAMIDE CAPSULE [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-946ZONISAMIDE CAPSULE [WOCKHARDT LIMITED]1Legacy NDC, 1 package rows20110301_d049bfcf-0634-4649-a782-12976ee4c49e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314285zonisamide 100 MG Oral CapsulePSNd049bfcf-0634-4649-a782-12976ee4c49e1
403966zonisamide 25 MG Oral CapsulePSNd049bfcf-0634-4649-a782-12976ee4c49e1
403967zonisamide 50 MG Oral CapsulePSNd049bfcf-0634-4649-a782-12976ee4c49e1
314285zonisamide 100 MG Oral CapsuleSCDd049bfcf-0634-4649-a782-12976ee4c49e1
403966zonisamide 25 MG Oral CapsuleSCDd049bfcf-0634-4649-a782-12976ee4c49e1
403967zonisamide 50 MG Oral CapsuleSCDd049bfcf-0634-4649-a782-12976ee4c49e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-946-0155648094601100 in 1 BOTTLEHistorical