FDA.reportPublic FDA data

OXCARBAZEPINE

Product NDC
0904-7264
11-digit product format
009047264
Labeler code
0904
Product ID
0904-7264_55b0fa69-7b11-49df-972a-e1d39b35b322
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA078069
Marketing category
ANDA
Marketing start
2022-11-07
Marketing end
2027-02-28
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OXCARBAZEPINE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXCARBAZEPINE600 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
0904-7264-61OXCARBAZEPINE1 in 1 BLISTER PACKTABLET, FILM COATED14
0904-7264-61OXCARBAZEPINE100 in 1 CARTONTABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7264-61EA - Each0904-72643bcfcb19-b0f2-4a8c-8047-7ee5dbcdf05912022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7264OXCARBAZEPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]2Current NDC, Legacy NDC, 2 package rows20240816_b1d54def-057d-4608-bc8f-1d967ac3ec91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSNb1d54def-057d-4608-bc8f-1d967ac3ec914
312137OXcarbazepine 300 MG Oral TabletPSNb1d54def-057d-4608-bc8f-1d967ac3ec914
312138OXcarbazepine 600 MG Oral TabletPSNb1d54def-057d-4608-bc8f-1d967ac3ec914
312136oxcarbazepine 150 MG Oral TabletSCDb1d54def-057d-4608-bc8f-1d967ac3ec914
312137oxcarbazepine 300 MG Oral TabletSCDb1d54def-057d-4608-bc8f-1d967ac3ec914
312138oxcarbazepine 600 MG Oral TabletSCDb1d54def-057d-4608-bc8f-1d967ac3ec914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7264-6100904726461100 BLISTER PACK in 1 CARTON (0904-7264-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2022-11-072027-02-28NoNoCurrent