Zonisamide

Product NDC
61919-591
11-digit product format
619190591
Labeler code
61919
Product ID
61919-591_4865755d-a929-4189-9cd7-e9b46bd011e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct Rx
Application
ANDA077651
Marketing category
ANDA
Marketing start
2015-01-01
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
61919-591-602020-01-31C16284748780-19d75b9d0-213d-f424-e053-dadaa90a57ceZonisamide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-591-60Zonisamide60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-591-60EA - Each61919-59192258161-076a-496d-b5b0-f534cfb7a2ab12016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZONISAMIDEACTIVE INGREDIENT459384H98VZONISAMIDE CAPSULE [DIRECT RX]1
ZONISAMIDEACTIVE MOIETY459384H98VZONISAMIDE CAPSULE [DIRECT RX]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MZONISAMIDE CAPSULE [DIRECT RX]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ZONISAMIDE CAPSULE [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZONISAMIDE CAPSULE [DIRECT RX]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GZONISAMIDE CAPSULE [DIRECT RX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZONISAMIDE CAPSULE [DIRECT RX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKZONISAMIDE CAPSULE [DIRECT RX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZONISAMIDE CAPSULE [DIRECT RX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZONISAMIDE CAPSULE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LZONISAMIDE CAPSULE [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZONISAMIDE CAPSULE [DIRECT RX]1
SHELLACINACTIVE INGREDIENT46N107B71OZONISAMIDE CAPSULE [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JZONISAMIDE CAPSULE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZONISAMIDE CAPSULE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-591ZONISAMIDE CAPSULE [DIRECT RX]1Legacy NDC, 1 package rows20150903_abfd24bb-480b-4661-827b-371185a90ae9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403967zonisamide 50 MG Oral CapsulePSNabfd24bb-480b-4661-827b-371185a90ae91
403967zonisamide 50 MG Oral CapsuleSCDabfd24bb-480b-4661-827b-371185a90ae91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-591-606191905916060 in 1 BOTTLEHistorical