Trileptal

Product NDC
55289-007
11-digit product format
552890007
Labeler code
55289
Product ID
55289-007_d83ed50a-ec21-4b28-e053-2995a90a0017
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
NDA021014
Marketing category
NDA
Marketing start
2000-01-30
Marketing end
0000-00-00
Substance
OXCARBAZEPINE
Active strength
300 mg/1
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
55289-007-30EA - Each55289-00748f24d63-562e-4f11-a36d-b5bc52f2284912012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-007-305528900073030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-007-30) 2011-03-170000-00-00NoNoCurrent