Zonisamide

Product NDC
70771-1143
11-digit product format
707711143
Labeler code
70771
Product ID
70771-1143_e34d1910-1076-499e-8f3e-1cb18e2a39eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA077625
Marketing category
ANDA
Marketing start
2017-11-22
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
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
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
70771-1143-1Zonisamide100 in 1 BOTTLECAPSULE1008
70771-1143-5Zonisamide500 in 1 BOTTLECAPSULE5008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1143ZONISAMIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED]8Current NDC, Legacy NDC, 2 package rows20240821_4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314285zonisamide 100 MG Oral CapsulePSN4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f8
403966zonisamide 25 MG Oral CapsulePSN4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f8
403967zonisamide 50 MG Oral CapsulePSN4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f8
314285zonisamide 100 MG Oral CapsuleSCD4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f8
403966zonisamide 25 MG Oral CapsuleSCD4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f8
403967zonisamide 50 MG Oral CapsuleSCD4a4de4ca-6e4a-4b62-b2b4-26cef6dafb2f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1143-170771114301100 CAPSULE in 1 BOTTLE (70771-1143-1) 100 capsule2017-11-220000-00-00NoNoCurrent
70771-1143-570771114305500 CAPSULE in 1 BOTTLE (70771-1143-5) 500 capsule2017-11-220000-00-00NoNoCurrent