Oxcarbazepine

Product NDC
68999-841
11-digit product format
689990841
Labeler code
68999
Product ID
68999-841_46dc543c-d51b-4dee-e063-6394a90a1856
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
SUSPENSION
Route
ORAL
Labeler
Chartwell Governmental & Specialty RX, LLC.
Application
ANDA212428
Marketing category
ANDA
Marketing start
2021-09-21
Substance
OXCARBAZEPINE
Active strength
300 mg/5mL
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/5mL

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68999-841-24Oxcarbazepine10 in 1 TRAYSUSPENSION101
68999-841-24Oxcarbazepine2 in 1 BOXSUSPENSION21
68999-841-45Oxcarbazepine5 mL in 1 CUPSUSPENSION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68999-841-24ML - Milliliter68999-8414f9e2b2d-746a-4bc2-9b87-3b6a5bb4ff5312026-02-05
68999-841-45ML - Milliliter68999-841de2894a5-a788-44e5-9504-188e48b241eb12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283536oxacarbazepine 300 MG in 5 mL Oral SuspensionPSNe74bb389-8426-4ffc-a14b-a5990de6d0d41
283536oxcarbazepine 60 MG/ML Oral SuspensionSCDe74bb389-8426-4ffc-a14b-a5990de6d0d41
283536oxacarbazepine 300 MG per 5 ML Oral SuspensionSYe74bb389-8426-4ffc-a14b-a5990de6d0d41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-841-24689990841242 TRAY in 1 BOX (68999-841-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-841-45) 2 tray2025-12-19NoNoHistorical
68999-841-45689990841455 mL in 1 CUP5 mlHistorical