oxcarbazepine

Product NDC
70771-1843
11-digit product format
707711843
Labeler code
70771
Product ID
70771-1843_905fd0b0-fd53-48f5-83ff-129a5f5f104c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxcarbazepine
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA211747
Marketing category
ANDA
Marketing start
2025-07-10
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
VZI5B1W380OXCARBAZEPINE28721-07-5OXCARBAZEPINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1843-0707711843001000 TABLET in 1 BOTTLE (70771-1843-0) 1000 tablet2025-07-10NoNoHistorical
70771-1843-170771184301100 TABLET in 1 BOTTLE (70771-1843-1) 100 tablet2025-07-10NoNoHistorical
70771-1843-47077118430410 BLISTER PACK in 1 CARTON (70771-1843-4) / 10 TABLET in 1 BLISTER PACK10 blister pack2025-07-10NoNoHistorical
70771-1843-570771184305500 TABLET in 1 BOTTLE (70771-1843-5) 500 tablet2025-07-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
oxcarbazepineZydus Lifesciences Limited2025-10-10HUMAN PRESCRIPTION DRUG LABEL3
oxcarbazepineZydus Lifesciences Limited2024-09-25HUMAN PRESCRIPTION DRUG LABEL2