Oxcarbazepine

Product NDC
62559-220
11-digit product format
625590220
Labeler code
62559
Product ID
62559-220_00918074-5761-4530-bb20-5cbf3efb84e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA078005
Marketing category
ANDA
Marketing start
2025-07-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxcarbazepine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXCARBAZEPINE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380
Rxcui312136, 312137, 312138

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca2a6da1-5711-44d0-9e79-c84d4265f98bProduct name320250724
536d5b6b-66f1-478b-2670-88fd15947e3bProduct name720250218

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-220-01Oxcarbazepine100 in 1 BOTTLETABLET, FILM COATED1002
62559-220-05Oxcarbazepine500 in 1 BOTTLETABLET, FILM COATED5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-220-01EA - Each62559-220e20e4018-31f9-45cd-a3fc-21f1bddd804712025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSN867eaf99-3e31-4f75-bfae-2898804d956d2
312137OXcarbazepine 300 MG Oral TabletPSN867eaf99-3e31-4f75-bfae-2898804d956d2
312138OXcarbazepine 600 MG Oral TabletPSN867eaf99-3e31-4f75-bfae-2898804d956d2
312136oxcarbazepine 150 MG Oral TabletSCD867eaf99-3e31-4f75-bfae-2898804d956d2
312137oxcarbazepine 300 MG Oral TabletSCD867eaf99-3e31-4f75-bfae-2898804d956d2
312138oxcarbazepine 600 MG Oral TabletSCD867eaf99-3e31-4f75-bfae-2898804d956d2
312136OXcarbazepine 150 MG Oral TabletPSNa14b5756-4fd1-4ba7-bc23-e1fa9212a1481
312137OXcarbazepine 300 MG Oral TabletPSNa14b5756-4fd1-4ba7-bc23-e1fa9212a1481
312138OXcarbazepine 600 MG Oral TabletPSNa14b5756-4fd1-4ba7-bc23-e1fa9212a1481
312136oxcarbazepine 150 MG Oral TabletSCDa14b5756-4fd1-4ba7-bc23-e1fa9212a1481
312137oxcarbazepine 300 MG Oral TabletSCDa14b5756-4fd1-4ba7-bc23-e1fa9212a1481
312138oxcarbazepine 600 MG Oral TabletSCDa14b5756-4fd1-4ba7-bc23-e1fa9212a1481

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62559-220-0162559022001100 TABLET, FILM COATED in 1 BOTTLE (62559-220-01) 2025-07-15NoNoHistorical
62559-220-0562559022005500 TABLET, FILM COATED in 1 BOTTLE (62559-220-05) 2025-07-15NoNoHistorical