OXCARBAZEPINE

Product NDC
72603-252
11-digit product format
726030252
Labeler code
72603
Product ID
72603-252_2d3c81f4-3e34-96f1-e063-6394a90a2e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
SUSPENSION
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA216749
Marketing category
ANDA
Marketing start
2024-05-01
Substance
OXCARBAZEPINE
Active strength
60 mg/mL
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
OXCARBAZEPINE60 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380
Rxcui283536

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca2a6da1-5711-44d0-9e79-c84d4265f98bProduct name320250724
536d5b6b-66f1-478b-2670-88fd15947e3bProduct name720250218
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-252-01OXCARBAZEPINE1 in 1 CARTONSUSPENSION12
72603-252-01OXCARBAZEPINE250 mL in 1 BOTTLESUSPENSION2502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-252-01ML - Milliliter72603-2523d499195-8902-4e80-bd66-1833fff6aa4812024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-252OXCARBAZEPINE (OXCARBAZEPINE) SUSPENSION [NORTHSTAR RXLLC]2Current NDC, 2 package rows20250205_1746d95f-c529-45ba-a520-0c135e8edda8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283536oxacarbazepine 300 MG in 5 mL Oral SuspensionPSN1746d95f-c529-45ba-a520-0c135e8edda82
283536oxcarbazepine 60 MG/ML Oral SuspensionSCD1746d95f-c529-45ba-a520-0c135e8edda82
283536oxacarbazepine 300 MG per 5 ML Oral SuspensionSY1746d95f-c529-45ba-a520-0c135e8edda82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-252-01726030252011 BOTTLE in 1 CARTON (72603-252-01) / 250 mL in 1 BOTTLE1 bottle2024-05-01NoNoCurrent