FDA.reportPublic FDA data

OXCARBAZEPINE

Product NDC
72603-271
11-digit product format
726030271
Labeler code
72603
Product ID
72603-271_4d362f13-5b27-b55f-e063-6394a90a1aae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA215939
Marketing category
ANDA
Marketing start
2024-09-01
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
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
OXCARBAZEPINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380
Rxcui312137, 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
72603-271-01OXCARBAZEPINE100 in 1 BOTTLETABLET, FILM COATED1003
72603-271-02OXCARBAZEPINE500 in 1 BOTTLETABLET, FILM COATED5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-271-01EA - Each72603-2714d78ae61-13a1-4cea-b85a-ac4f1db4c6d712024-10-04
72603-271-02EA - Each72603-271d197ebb2-30f5-4cbd-88f8-1d5df2f9f7bc12025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-271OXCARBAZEPINE (OXCARBAZEPINE) TABLET, FILM COATED [NORTHSTAR RXLLC]2Current NDC, 2 package rows20250524_20d826cd-fa4a-4570-9e10-9d7d10fb725b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312137OXcarbazepine 300 MG Oral TabletPSN20d826cd-fa4a-4570-9e10-9d7d10fb725b3
312138OXcarbazepine 600 MG Oral TabletPSN20d826cd-fa4a-4570-9e10-9d7d10fb725b3
312137oxcarbazepine 300 MG Oral TabletSCD20d826cd-fa4a-4570-9e10-9d7d10fb725b3
312138oxcarbazepine 600 MG Oral TabletSCD20d826cd-fa4a-4570-9e10-9d7d10fb725b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-271-0172603027101100 TABLET, FILM COATED in 1 BOTTLE (72603-271-01) 2024-09-01NoNoCurrent
72603-271-0272603027102500 TABLET, FILM COATED in 1 BOTTLE (72603-271-02) 2025-04-28NoNoCurrent