OXCARBAZEPINE

Product NDC
70518-2253
11-digit product format
705182253
Labeler code
70518
Product ID
70518-2253_4dd9ce1d-3f6f-4190-e063-6294a90aabc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078069
Marketing category
ANDA
Marketing start
2019-08-05
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OXCARBAZEPINE
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2253-0OXCARBAZEPINE30 in 1 BLISTER PACKTABLET, FILM COATED3015
70518-2253-1OXCARBAZEPINE100 in 1 BOXTABLET, FILM COATED10015
70518-2253-2OXCARBAZEPINE1 in 1 POUCHTABLET, FILM COATED115

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2253OXCARBAZEPINE TABLET, FILM COATED [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 3 package rows20250524_b571ee0f-3c2a-4c55-9c2b-e00014e2ec7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSNb571ee0f-3c2a-4c55-9c2b-e00014e2ec7a15
312136oxcarbazepine 150 MG Oral TabletSCDb571ee0f-3c2a-4c55-9c2b-e00014e2ec7a15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2253-07051822530030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2253-0) 2019-08-050000-00-00NoNoCurrent
70518-2253-170518225301100 POUCH in 1 BOX (70518-2253-1) > 1 TABLET, FILM COATED in 1 POUCH (70518-2253-2) 100 pouch2021-08-030000-00-00NoNoCurrent
70518-2253-2705182253021 in 1 POUCHHistorical