Oxcarbazepine

Product NDC
50268-649
11-digit product format
502680649
Labeler code
50268
Product ID
50268-649_ed85a3c4-5221-9051-e053-2a95a90a703b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
SUSPENSION
Route
ORAL
Labeler
AvPAK
Application
ANDA202961
Marketing category
ANDA
Marketing start
2021-06-14
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
50268-649-05Oxcarbazepine5 mL in 1 CUP, UNIT-DOSESUSPENSION52
50268-649-30Oxcarbazepine30 in 1 TRAYSUSPENSION302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-649-05ML - Milliliter50268-649e979131c-189c-4618-8e08-111a5345ac7a12023-06-06
50268-649-11ML - Milliliter50268-6497117897c-61f6-4b5f-b893-1a59d27b9f5412021-07-15
50268-649-12ML - Milliliter50268-6496203741d-44c4-44a2-907b-a2fd98e2992312021-07-15
50268-649-30ML - Milliliter50268-64972ace23b-7715-4882-9b3d-26d71a86d20312023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-649OXCARBAZEPINE SUSPENSION [AVPAK]2Legacy NDC, 2 package rows20230419_f89a012f-3c0c-5b80-e053-6394a90ad99f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283536oxacarbazepine 300 MG in 5 mL Oral SuspensionPSNf89a012f-3c0c-5b80-e053-6394a90ad99f2
283536oxcarbazepine 60 MG/ML Oral SuspensionSCDf89a012f-3c0c-5b80-e053-6394a90ad99f2
283536oxacarbazepine 300 MG per 5 ML Oral SuspensionSYf89a012f-3c0c-5b80-e053-6394a90ad99f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-649-05502680649055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
50268-649-125026806491220 CUP, UNIT-DOSE in 1 BOX (50268-649-12) > 5 mL in 1 CUP, UNIT-DOSE (50268-649-11) 2021-06-140000-00-00NoNoCurrent
50268-649-305026806493030 in 1 TRAYHistorical