TRILEPTAL

Product NDC
61919-569
11-digit product format
619190569
Labeler code
61919
Product ID
61919-569_33af9350-95f4-384e-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXCARBAZEPINE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077802
Marketing category
ANDA
Marketing start
2016-05-25
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
E
Listing certified through
2017-12-31
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
61919-569-30TRILEPTAL30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-569-30EA - Each61919-569b16252ad-619a-45aa-95c0-b0b6294486f012019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-569TRILEPTAL (OXCARBAZEPINE) TABLET [DIRECT RX]1Legacy NDC, 1 package rows20160526_33af9350-95f3-384e-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312137OXcarbazepine 300 MG Oral TabletPSN33af9350-95f3-384e-e054-00144ff88e881
261360Trileptal 300 MG Oral TabletPSN33af9350-95f3-384e-e054-00144ff88e881
261360oxcarbazepine 300 MG Oral Tablet [Trileptal]SBD33af9350-95f3-384e-e054-00144ff88e881
312137oxcarbazepine 300 MG Oral TabletSCD33af9350-95f3-384e-e054-00144ff88e881
261360Trileptal 300 MG Oral TabletSY33af9350-95f3-384e-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-569-306191905693030 in 1 BOTTLEHistorical