Zonisamide

Product NDC
70518-4349
11-digit product format
705184349
Labeler code
70518
Product ID
70518-4349_365be0d1-cb8d-861b-e063-6294a90a9d8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077645
Marketing category
ANDA
Marketing start
2025-05-30
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
459384H98VZONISAMIDE68291-97-4ZONISAMIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4349-070518434900100 POUCH in 1 BOX (70518-4349-0) / 1 CAPSULE in 1 POUCH (70518-4349-1) 100 pouch2025-05-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ZONISAMIDE CAPSULES USP Rx OnlyREMEDYREPACK INC.2025-05-30HUMAN PRESCRIPTION DRUG LABEL1