Zonisamide

Product NDC
68382-214
11-digit product format
683820214
Labeler code
68382
Product ID
68382-214_61639a39-ae22-47e9-9bc0-97fb0c5c2c2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA077625
Marketing category
ANDA
Marketing start
2017-11-22
Marketing end
0000-00-00
Substance
ZONISAMIDE
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-214-0168382021401100 CAPSULE in 1 BOTTLE (68382-214-01) 100 capsule2017-11-220000-00-00NoNoCurrent
68382-214-0568382021405500 CAPSULE in 1 BOTTLE (68382-214-05) 500 capsule2017-11-220000-00-00NoNoCurrent
68382-214-10683820214101000 CAPSULE in 1 BOTTLE (68382-214-10) 1000 capsule2017-11-220000-00-00NoNoCurrent