Oxcarbazepine

Product NDC
70518-1027
11-digit product format
705181027
Labeler code
70518
Product ID
70518-1027_dfc1c173-fd74-62cd-e053-2a95a90a1b47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077794
Marketing category
ANDA
Marketing start
2018-02-20
Marketing end
0000-00-00
Substance
OXCARBAZEPINE
Active strength
600 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1027-07051810270030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1027-0) 2018-02-200000-00-00NoNoCurrent
70518-1027-170518102701100 POUCH in 1 BOX (70518-1027-1) > 1 TABLET, FILM COATED in 1 POUCH (70518-1027-2) 100 pouch2021-08-180000-00-00NoNoCurrent
70518-1027-370518102703100 POUCH in 1 BOX (70518-1027-3) > 1 TABLET, FILM COATED in 1 POUCH (70518-1027-4) 100 pouch2021-09-200000-00-00NoNoCurrent