Oxcarbazepine

Product NDC
70518-3127
11-digit product format
705183127
Labeler code
70518
Product ID
70518-3127_ef17b4bf-f20e-4a6d-e053-2a95a90ae494
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077802
Marketing category
ANDA
Marketing start
2021-06-17
Marketing end
0000-00-00
Substance
OXCARBAZEPINE
Active strength
150 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
70518-3127-070518312700100 POUCH in 1 BOX (70518-3127-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-3127-1) 100 pouch2021-06-170000-00-00NoNoCurrent
70518-3127-27051831270230 TABLET, FILM COATED in 1 BLISTER PACK (70518-3127-2) 2022-12-050000-00-00NoNoCurrent