Zonisamide

Product NDC
68001-243
11-digit product format
680010243
Labeler code
68001
Product ID
68001-243_4c366d7a-f281-bb5b-e063-6294a90a7b60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA077651
Marketing category
ANDA
Marketing start
2014-03-13
Substance
ZONISAMIDE
Active strength
50 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zonisamide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZONISAMIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii459384H98V
Rxcui314285, 403966, 403967

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-243-00Zonisamide100 in 1 BOTTLECAPSULE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-243-00EA - Each68001-243d388cb73-ce30-4693-ae23-3f5e01414f2a12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZONISAMIDEACTIVE INGREDIENT459384H98VZONISAMIDE CAPSULE [BLUEPOINT LABORATORIES]4
ZONISAMIDEACTIVE MOIETY459384H98VZONISAMIDE CAPSULE [BLUEPOINT LABORATORIES]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MZONISAMIDE CAPSULE [BLUEPOINT LABORATORIES]4
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ZONISAMIDE CAPSULE [BLUEPOINT LABORATORIES]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZONISAMIDE CAPSULE [BLUEPOINT LABORATORIES]4
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHZONISAMIDE CAPSULE [BLUEPOINT LABORATORIES]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GZONISAMIDE CAPSULE [BLUEPOINT LABORATORIES]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZONISAMIDE CAPSULE [BLUEPOINT LABORATORIES]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKZONISAMIDE CAPSULE [BLUEPOINT LABORATORIES]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZONISAMIDE CAPSULE [BLUEPOINT LABORATORIES]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ZONISAMIDE CAPSULE [BLUEPOINT LABORATORIES]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZONISAMIDE CAPSULE [BLUEPOINT LABORATORIES]4
GELATININACTIVE INGREDIENT2G86QN327LZONISAMIDE CAPSULE [BLUEPOINT LABORATORIES]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZONISAMIDE CAPSULE [BLUEPOINT LABORATORIES]4
SHELLACINACTIVE INGREDIENT46N107B71OZONISAMIDE CAPSULE [BLUEPOINT LABORATORIES]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JZONISAMIDE CAPSULE [BLUEPOINT LABORATORIES]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZONISAMIDE CAPSULE [BLUEPOINT LABORATORIES]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-243ZONISAMIDE CAPSULE [BLUEPOINT LABORATORIES]8Current NDC, Legacy NDC, 1 package rows20200926_345efcc4-6a36-4ddf-8b6c-9c6c844dab0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314285zonisamide 100 MG Oral CapsulePSN345efcc4-6a36-4ddf-8b6c-9c6c844dab0a9
403966zonisamide 25 MG Oral CapsulePSN345efcc4-6a36-4ddf-8b6c-9c6c844dab0a9
403967zonisamide 50 MG Oral CapsulePSN345efcc4-6a36-4ddf-8b6c-9c6c844dab0a9
314285zonisamide 100 MG Oral CapsuleSCD345efcc4-6a36-4ddf-8b6c-9c6c844dab0a9
403966zonisamide 25 MG Oral CapsuleSCD345efcc4-6a36-4ddf-8b6c-9c6c844dab0a9
403967zonisamide 50 MG Oral CapsuleSCD345efcc4-6a36-4ddf-8b6c-9c6c844dab0a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-243-0068001024300100 CAPSULE in 1 BOTTLE (68001-243-00) 100 capsule2014-03-130000-00-00NoNoCurrent