OXCARBAZEPINE

Product NDC
70518-4465
11-digit product format
705184465
Labeler code
70518
Product ID
70518-4465_410a667a-7fe5-166b-e063-6294a90a730d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078069
Marketing category
ANDA
Marketing start
2025-09-04
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXCARBAZEPINE600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380
Rxcui312138

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca2a6da1-5711-44d0-9e79-c84d4265f98bProduct name320250724
536d5b6b-66f1-478b-2670-88fd15947e3bProduct name720250218
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4465-0OXCARBAZEPINE30 in 1 BLISTER PACKTABLET, FILM COATED302
70518-4465-1OXCARBAZEPINE100 in 1 BOXTABLET, FILM COATED1002
70518-4465-2OXCARBAZEPINE1 in 1 POUCHTABLET, FILM COATED12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312138OXcarbazepine 600 MG Oral TabletPSN1176d5f5-3447-4925-aed8-1a1cb4b5989d2
312138oxcarbazepine 600 MG Oral TabletSCD1176d5f5-3447-4925-aed8-1a1cb4b5989d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4465-07051844650030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4465-0) 2025-09-04NoNoHistorical
70518-4465-170518446501100 POUCH in 1 BOX (70518-4465-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-4465-2) 100 pouch2025-10-12NoNoHistorical
70518-4465-2705184465021 in 1 POUCHHistorical