zonisamide

Product NDC
70518-3180
11-digit product format
705183180
Labeler code
70518
Product ID
70518-3180_c8d185b0-89f3-7155-e053-2995a90aa2f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zonisamide
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077869
Marketing category
ANDA
Marketing start
2021-08-04
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3180-02023-02-13C16284748780-1f386c649-c8c3-0266-e053-dadaa90a7c1a09854775-55db-446c-a06e-d883563199e8
70518-3180-02023-01-30C16284748780-1f386c649-c8c3-0266-e053-dadaa90a7c1a09854775-55db-446c-a06e-d883563199e8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3180ZONISAMIDE CAPSULE [REMEDYREPACK INC.]3Legacy NDC20240315_09854775-55db-446c-a06e-d883563199e8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3180-070518318000100 POUCH in 1 BOX (70518-3180-0) > 1 CAPSULE in 1 POUCH (70518-3180-1) 100 pouch2021-08-040000-00-00NoNoCurrent