FDA.reportPublic FDA data

Oxcarbazepine

Product NDC
60687-722
11-digit product format
606870722
Labeler code
60687
Product ID
60687-722_2f12e2dc-a3df-01a8-e063-6294a90abd4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA215939
Marketing category
ANDA
Marketing start
2023-01-24
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
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
60687-722-01Oxcarbazepine100 in 1 CARTONTABLET, FILM COATED1006
60687-722-11Oxcarbazepine1 in 1 BLISTER PACKTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-722-01EA - Each60687-722047b12c8-64b7-4a7c-b1fa-5350f46b28bb12023-02-06
60687-722-11EA - Each60687-722cdee6b9f-bb11-4a11-a627-160f9dcfb57112023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-722OXCARBAZEPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20250302_c0f9df3f-280e-4394-8d7e-ad04803b2635.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312136OXcarbazepine 150 MG Oral TabletPSNc0f9df3f-280e-4394-8d7e-ad04803b26356
312137OXcarbazepine 300 MG Oral TabletPSNc0f9df3f-280e-4394-8d7e-ad04803b26356
312138OXcarbazepine 600 MG Oral TabletPSNc0f9df3f-280e-4394-8d7e-ad04803b26356
312136oxcarbazepine 150 MG Oral TabletSCDc0f9df3f-280e-4394-8d7e-ad04803b26356
312137oxcarbazepine 300 MG Oral TabletSCDc0f9df3f-280e-4394-8d7e-ad04803b26356
312138oxcarbazepine 600 MG Oral TabletSCDc0f9df3f-280e-4394-8d7e-ad04803b26356
312136OXcarbazepine 150 MG Oral TabletPSN3e0f8d9f-7659-4524-8f93-6200314356c85
312137OXcarbazepine 300 MG Oral TabletPSN3e0f8d9f-7659-4524-8f93-6200314356c85
312136oxcarbazepine 150 MG Oral TabletSCD3e0f8d9f-7659-4524-8f93-6200314356c85
312137oxcarbazepine 300 MG Oral TabletSCD3e0f8d9f-7659-4524-8f93-6200314356c85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-722-0160687072201100 BLISTER PACK in 1 CARTON (60687-722-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-722-11) 100 blister pack2023-01-240000-00-00NoNoCurrent
60687-722-11606870722111 in 1 BLISTER PACKHistorical