FDA.reportPublic FDA data

OXCARBAZEPINE

Product NDC
60505-4129
11-digit product format
605054129
Labeler code
60505
Product ID
60505-4129_f106ef3d-7def-b2e5-2428-60ecd16326f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA213369
Marketing category
ANDA
Marketing start
2024-09-03
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXCARBAZEPINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380
Rxcui1365653, 1365842, 1365844

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
60505-4129-5OXCARBAZEPINE500 in 1 BOTTLETABLET, EXTENDED RELEASE5006
60505-4129-7OXCARBAZEPINE100 in 1 BOTTLETABLET, EXTENDED RELEASE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4129-7EA - Each60505-41292d1148c3-9ddc-4df1-b654-befe985339b412024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4129OXCARBAZEPINE TABLET, EXTENDED RELEASE [APOTEX CORP.]5Current NDC, 2 package rows20240913_a20e4a95-8ee1-e702-003e-e353ec1ee133.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1365653OXcarbazepine 150 MG 24HR Extended Release Oral TabletPSNa20e4a95-8ee1-e702-003e-e353ec1ee1336
1365842OXcarbazepine 300 MG 24HR Extended Release Oral TabletPSNa20e4a95-8ee1-e702-003e-e353ec1ee1336
1365844OXcarbazepine 600 MG 24HR Extended Release Oral TabletPSNa20e4a95-8ee1-e702-003e-e353ec1ee1336
136565324 HR oxcarbazepine 150 MG Extended Release Oral TabletSCDa20e4a95-8ee1-e702-003e-e353ec1ee1336
136584224 HR oxcarbazepine 300 MG Extended Release Oral TabletSCDa20e4a95-8ee1-e702-003e-e353ec1ee1336
136584424 HR oxcarbazepine 600 MG Extended Release Oral TabletSCDa20e4a95-8ee1-e702-003e-e353ec1ee1336
1365653oxcarbazepine 150 MG 24 HR Extended Release Oral TabletSYa20e4a95-8ee1-e702-003e-e353ec1ee1336
1365842oxcarbazepine 300 MG 24 HR Extended Release Oral TabletSYa20e4a95-8ee1-e702-003e-e353ec1ee1336
1365844oxcarbazepine 600 MG 24 HR Extended Release Oral TabletSYa20e4a95-8ee1-e702-003e-e353ec1ee1336

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60505-4129-560505412905500 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4129-5) 2024-09-03NoNoHistorical
60505-4129-760505412907100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-4129-7) 2024-09-03NoNoHistorical