FDA.reportPublic FDA data

zonisamide

Product NDC
69097-861
11-digit product format
690970861
Labeler code
69097
Product ID
69097-861_37025923-f696-46ab-95fb-b38c30e6004b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA077869
Marketing category
ANDA
Marketing start
2016-07-13
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
zonisamide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZONISAMIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii459384H98V
Rxcui314285

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
69097-861-07zonisamide100 in 1 BOTTLECAPSULE1003
69097-861-12zonisamide500 in 1 BOTTLECAPSULE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-861-07EA - Each69097-86138b792e4-4e14-473e-aae8-676a4ba78ea612016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZONISAMIDEACTIVE INGREDIENT459384H98VZONISAMIDE CAPSULE [AVPAK]2
ZONISAMIDEACTIVE MOIETY459384H98VZONISAMIDE CAPSULE [AVPAK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZONISAMIDE CAPSULE [AVPAK]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZONISAMIDE CAPSULE [AVPAK]2
GELATININACTIVE INGREDIENT2G86QN327LZONISAMIDE CAPSULE [AVPAK]2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYZONISAMIDE CAPSULE [AVPAK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZONISAMIDE CAPSULE [AVPAK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-861ZONISAMIDE CAPSULE [CIPLA USA INC.]3Current NDC, Legacy NDC, 2 package rows20200822_e8f368cb-6a07-4178-95fa-1d5a209171ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314285zonisamide 100 MG Oral CapsulePSNb20a51ef-255e-1eb0-c0e1-461cde46b88710
314285zonisamide 100 MG Oral CapsuleSCDb20a51ef-255e-1eb0-c0e1-461cde46b88710
314285zonisamide 100 MG Oral CapsulePSN226d917a-33de-48cc-baf6-bd6a206683418
314285zonisamide 100 MG Oral CapsulePSN7cdd96c4-3263-4c28-86c0-3c24bcef16c18
314285zonisamide 100 MG Oral CapsuleSCD226d917a-33de-48cc-baf6-bd6a206683418
314285zonisamide 100 MG Oral CapsuleSCD7cdd96c4-3263-4c28-86c0-3c24bcef16c18
314285zonisamide 100 MG Oral CapsulePSN64bd9d6f-8cc0-4151-a78d-9f1437b368755
314285zonisamide 100 MG Oral CapsuleSCD64bd9d6f-8cc0-4151-a78d-9f1437b368755
314285zonisamide 100 MG Oral CapsulePSNe8f368cb-6a07-4178-95fa-1d5a209171ed3
314285zonisamide 100 MG Oral CapsuleSCDe8f368cb-6a07-4178-95fa-1d5a209171ed3
314285zonisamide 100 MG Oral CapsulePSN66c509ab-ecf3-48ff-bb6d-97989f3b747b1
314285zonisamide 100 MG Oral CapsuleSCD66c509ab-ecf3-48ff-bb6d-97989f3b747b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-861-0769097086107100 CAPSULE in 1 BOTTLE (69097-861-07) 100 capsule2016-07-130000-00-00NoNoCurrent
69097-861-1269097086112500 CAPSULE in 1 BOTTLE (69097-861-12) 500 capsule2016-07-130000-00-00NoNoCurrent