Zonisamide

Product NDC
71205-727
11-digit product format
712050727
Labeler code
71205
Product ID
71205-727_b4b0ee6a-d4cf-4f29-b9ff-fd5ffc1ce7e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA214492
Marketing category
ANDA
Marketing start
2021-07-09
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
71205-727-30Zonisamide30 in 1 BOTTLECAPSULE301
71205-727-60Zonisamide60 in 1 BOTTLECAPSULE601
71205-727-90Zonisamide90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-727-30EA - Each71205-7278d4b9781-c89b-4c9b-876b-eadc75270ca212023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-727ZONISAMIDE CAPSULE [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20221211_b4b0ee6a-d4cf-4f29-b9ff-fd5ffc1ce7e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314285zonisamide 100 MG Oral CapsulePSNb4b0ee6a-d4cf-4f29-b9ff-fd5ffc1ce7e11
314285zonisamide 100 MG Oral CapsuleSCDb4b0ee6a-d4cf-4f29-b9ff-fd5ffc1ce7e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-727-307120507273030 CAPSULE in 1 BOTTLE (71205-727-30) 30 capsule2022-12-080000-00-00NoNoCurrent
71205-727-607120507276060 CAPSULE in 1 BOTTLE (71205-727-60) 60 capsule2022-12-080000-00-00NoNoCurrent
71205-727-907120507279090 CAPSULE in 1 BOTTLE (71205-727-90) 90 capsule2022-12-080000-00-00NoNoCurrent