Oxcarbazepine

Product NDC
70518-3940
11-digit product format
705183940
Labeler code
70518
Product ID
70518-3940_3bb1f07f-7b7d-9b1f-e063-6394a90ae5e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA215939
Marketing category
ANDA
Marketing start
2023-12-06
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca2a6da1-5711-44d0-9e79-c84d4265f98bProduct name320250724
536d5b6b-66f1-478b-2670-88fd15947e3bProduct name720250218
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3940-0Oxcarbazepine30 in 1 BLISTER PACKTABLET, FILM COATED307
70518-3940-1Oxcarbazepine100 in 1 BOXTABLET, FILM COATED1007
70518-3940-2Oxcarbazepine1 in 1 POUCHTABLET, FILM COATED17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3940OXCARBAZEPINE TABLET, FILM COATED [REMEDYREPACK INC.]6Current NDC, 3 package rows20250426_188a48ad-c412-416a-b15b-de5f232740a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSN188a48ad-c412-416a-b15b-de5f232740a27
312136oxcarbazepine 150 MG Oral TabletSCD188a48ad-c412-416a-b15b-de5f232740a27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3940-07051839400030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3940-0) 2023-12-06NoNoHistorical
70518-3940-170518394001100 POUCH in 1 BOX (70518-3940-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-3940-2) 100 pouch2024-02-24NoNoHistorical
70518-3940-2705183940021 in 1 POUCHHistorical