Oxcarbazepine

Product NDC
50383-312
11-digit product format
503830312
Labeler code
50383
Product ID
50383-312_7d0b0260-09a3-43fa-90b0-76a24cd190ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxcarbazepine
Dosage form
SUSPENSION
Route
ORAL
Labeler
Akorn
Application
ANDA211420
Marketing category
ANDA
Marketing start
2021-07-07
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-312-84ML - Milliliter50383-31266a40b7a-7ef9-4b92-aef2-bdcb5703abc212021-09-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-312-84503830312841 BOTTLE in 1 CARTON (50383-312-84) > 250 mL in 1 BOTTLE1 bottle2021-07-070000-00-00NoNoCurrent