Oxcarbazepine

Product NDC
71428-007
11-digit product format
714280007
Labeler code
71428
Product ID
71428-007_ee9d7ea0-c2ea-52cb-e053-2995a90a5ff7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxcarbazepine
Dosage form
SUSPENSION
Route
ORAL
Labeler
Glasshouse Pharmaceuticals Limited Canada
Application
ANDA212428
Marketing category
ANDA
Marketing start
2021-09-21
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71428-007-25714280007251 BOTTLE in 1 CARTON (71428-007-25) > 250 mL in 1 BOTTLE1 bottle2021-09-210000-00-00NoNoCurrent