FDA.reportPublic FDA data

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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-569UExcluded because listing certification expired2026-07-31
excluded packagepackage61919-56961919-569-30UExcluded because listing certification expired2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077802-001OXCARBAZEPINEOXCARBAZEPINE150MGTABLET / ORALAB2007-10-09
A077802-002OXCARBAZEPINEOXCARBAZEPINE300MGTABLET / ORALAB2007-10-09
A077802-003OXCARBAZEPINEOXCARBAZEPINE600MGTABLET / ORALAB2007-10-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077802-001AB
A077802-002AB
A077802-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077802-001OXCARBAZEPINE150MGTABLET / ORALAB2007-10-09a50c72e98297…
2026-08-01 22:54:322026-06A077802-002OXCARBAZEPINE300MGTABLET / ORALAB2007-10-09a50c72e98297…
2026-08-01 22:54:322026-06A077802-003OXCARBAZEPINE600MGTABLET / ORALAB2007-10-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077802-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077802-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077802-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxcarbazepineOXCARBAZEPINECoupler LLC51008af2-39ac-546c-e063-6294a90a758f2026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802
OxcarbazepineOXCARBAZEPINECoupler LLC50873ef7-3deb-7386-e063-6394a90a9c192026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802
OxcarbazepineOXCARBAZEPINEREMEDYREPACK INC.a90cd1f1-5258-4b0e-92fd-c4cebe47772b2026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802
OxcarbazepineOXCARBAZEPINEREMEDYREPACK INC.a2032bcc-2da5-45e5-aa3f-ddbf50909df82026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802
OxcarbazepineOXCARBAZEPINEGlenmark Pharmaceuticals Inc., USA1c713b59-a628-42e6-b166-ae71c39132842025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802
OxcarbazepineOXCARBAZEPINEDirect_rx21b0cc84-b64a-75de-e063-6294a90a9dd02024-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802
OxcarbazepineOXCARBAZEPINEProficient Rx LP95867dcd-fd0e-4570-987b-d35939f7d7d12022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077802
application number: ANDA077802

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