FDA.reportPublic FDA data

Oxcarbazepine

Product NDC
62135-841
11-digit product format
621350841
Labeler code
62135
Product ID
62135-841_47e4dcae-6305-e681-e063-6294a90a5359
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
SUSPENSION
Route
ORAL
Labeler
Chartwell 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
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/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
62135-841-24Oxcarbazepine20 in 1 CARTONSUSPENSION204
62135-841-45Oxcarbazepine5 mL in 1 CUP, UNIT-DOSESUSPENSION54
62135-841-54Oxcarbazepine250 mL in 1 BOTTLESUSPENSION2504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-841-24ML - Milliliter62135-841a4a365f2-6e81-450e-bcd9-1a70de9452d312024-09-09
62135-841-45ML - Milliliter62135-841e8f1d98a-ae4c-46ab-b585-7c19920b157a12024-09-09
62135-841-54ML - Milliliter62135-8416d8c742b-0e70-4865-bcd5-2a051e03a8f112024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-841OXCARBAZEPINE SUSPENSION [CHARTWELL RX, LLC]3Current NDC, 3 package rows20240531_c2affa00-1d57-4d85-8db3-745191b4714d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283536oxacarbazepine 300 MG in 5 mL Oral SuspensionPSNc2affa00-1d57-4d85-8db3-745191b4714d4
283536oxcarbazepine 60 MG/ML Oral SuspensionSCDc2affa00-1d57-4d85-8db3-745191b4714d4
283536oxacarbazepine 300 MG per 5 ML Oral SuspensionSYc2affa00-1d57-4d85-8db3-745191b4714d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-841-246213508412420 CUP, UNIT-DOSE in 1 CARTON (62135-841-24) / 5 mL in 1 CUP, UNIT-DOSE (62135-841-45) 2024-03-27NoNoHistorical
62135-841-45621350841455 mL in 1 CUP, UNIT-DOSE5 mlHistorical
62135-841-5462135084154250 mL in 1 BOTTLE (62135-841-54) 250 ml2024-03-27NoNoHistorical