Oxcarbazepine

Product NDC
87063-208
11-digit product format
870630208
Labeler code
87063
Product ID
87063-208_52252957-7c1f-f080-e063-6394a90ac890
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ASCLEMED USA INC.
Application
ANDA215939
Marketing category
ANDA
Marketing start
2022-01-11
Substance
OXCARBAZEPINE
Active strength
300 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
VZI5B1W380OXCARBAZEPINE28721-07-5OXCARBAZEPINE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
87063-208-0187063020801100 TABLET, FILM COATED in 1 BOTTLE (87063-208-01) 2026-05-19NoNoHistorical
87063-208-308706302083030 TABLET, FILM COATED in 1 BOTTLE (87063-208-30) 2026-05-19NoNoHistorical
87063-208-608706302086060 TABLET, FILM COATED in 1 BOTTLE (87063-208-60) 2026-05-19NoNoHistorical
87063-208-908706302089090 TABLET, FILM COATED in 1 BOTTLE (87063-208-90) 2026-05-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OxcarbazepineASCLEMED USA INC. | ASCLEMED USA INC. DBA ENOVACHEM2026-05-19HUMAN PRESCRIPTION DRUG LABEL1