FDA.reportPublic FDA data

Oxcarbazepine

Product NDC
72888-089
11-digit product format
728880089
Labeler code
72888
Product ID
72888-089_4b920b8e-b260-b6a0-e063-6294a90a3490
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA077747
Marketing category
ANDA
Marketing start
2021-03-19
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
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
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
72888-089-01Oxcarbazepine100 in 1 BOTTLETABLET, FILM COATED1003
72888-089-05Oxcarbazepine500 in 1 BOTTLETABLET, FILM COATED5003
72888-089-30Oxcarbazepine30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-089-01EA - Each72888-089de81928b-9750-4490-88d2-ea6d20315e4912023-09-05
72888-089-05EA - Each72888-08974329f25-f556-4c4f-920b-f75816b26a2312023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-089OXCARBAZEPINE TABLET, FILM COATED [ADVAGEN PHARMA LIMITED]1Current NDC, 3 package rows20230607_b0bc10f0-7d1b-4adc-bc59-c48dab58ee5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSNb0bc10f0-7d1b-4adc-bc59-c48dab58ee5a3
312137OXcarbazepine 300 MG Oral TabletPSNb0bc10f0-7d1b-4adc-bc59-c48dab58ee5a3
312138OXcarbazepine 600 MG Oral TabletPSNb0bc10f0-7d1b-4adc-bc59-c48dab58ee5a3
312136oxcarbazepine 150 MG Oral TabletSCDb0bc10f0-7d1b-4adc-bc59-c48dab58ee5a3
312137oxcarbazepine 300 MG Oral TabletSCDb0bc10f0-7d1b-4adc-bc59-c48dab58ee5a3
312138oxcarbazepine 600 MG Oral TabletSCDb0bc10f0-7d1b-4adc-bc59-c48dab58ee5a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72888-089-0172888008901100 TABLET, FILM COATED in 1 BOTTLE (72888-089-01) 2021-03-19NoNoCurrent
72888-089-0572888008905500 TABLET, FILM COATED in 1 BOTTLE (72888-089-05) 2021-03-19NoNoCurrent
72888-089-307288800893030 TABLET, FILM COATED in 1 BOTTLE (72888-089-30) 2021-03-19NoNoCurrent