OXCARBAZEPINE

Product NDC
63629-6834
11-digit product format
636296834
Labeler code
63629
Product ID
63629-6834_ad785cbb-ae12-4261-9fb2-a86b8735606d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078069
Marketing category
ANDA
Marketing start
2008-01-11
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
VZI5B1W380OXCARBAZEPINE28721-07-5OXCARBAZEPINE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63629-6834-16362968340130 TABLET, FILM COATED in 1 BOTTLE (63629-6834-1) 2016-06-27NoNoHistorical
63629-6834-26362968340260 TABLET, FILM COATED in 1 BOTTLE (63629-6834-2) 2015-11-02NoNoHistorical
63629-6834-36362968340390 TABLET, FILM COATED in 1 BOTTLE (63629-6834-3) 2016-07-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OXCARBAZEPINEBryant Ranch Prepack2024-04-02HUMAN PRESCRIPTION DRUG LABEL9