FDA.reportPublic FDA data

Trileptal

Product NDC
0078-0337
11-digit product format
000780337
Labeler code
0078
Product ID
0078-0337_dcd739ce-e938-40e6-8912-ca4f34b49cf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxcarbazepine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA021014
Marketing category
NDA
Marketing start
2000-01-30
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Trileptal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXCARBAZEPINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZI5B1W380
Rxcui261356, 261360, 262090, 283536, 312136, 312137, 312138, 351992

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ca2a6da1-5711-44d0-9e79-c84d4265f98bProduct name320250724
536d5b6b-66f1-478b-2670-88fd15947e3bProduct name720250218
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0337-05Trileptal100 in 1 BOTTLETABLET, FILM COATED10039
0078-0337-06Trileptal100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10039
0078-0337-61Trileptal1 in 1 BLISTER PACKTABLET, FILM COATED139

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0337-05EA - Each0078-0337b4424458-cb22-4259-b023-555e56822f5312012-07-24
0078-0337-06EA - Each0078-0337d0529c55-60b2-4ed9-88df-85d53014d38312012-07-24
0078-0337-61EA - Each0078-0337823c9f76-ba1c-43a6-b5d0-cd070e3b2c1212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXCARBAZEPINEACTIVE INGREDIENTVZI5B1W380TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
OXCARBAZEPINEACTIVE MOIETYVZI5B1W380TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
ALCOHOLINACTIVE INGREDIENT3K9958V90MTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
LEMONINACTIVE INGREDIENT24RS0A988OTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
PLUMINACTIVE INGREDIENT67M3EQ6BE1TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
SORBITOLINACTIVE INGREDIENT506T60A25RTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
TALCINACTIVE INGREDIENT7SEV7J4R1UTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
WATERINACTIVE INGREDIENT059QF0KO0RTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]20
OXCARBAZEPINEACTIVE INGREDIENTVZI5B1W380TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
OXCARBAZEPINEACTIVE MOIETYVZI5B1W380TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ATRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0337TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]37Current NDC, Legacy NDC, 3 package rows20250122_4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283536oxacarbazepine 300 MG in 5 mL Oral SuspensionPSN4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
312136OXcarbazepine 150 MG Oral TabletPSN4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
312137OXcarbazepine 300 MG Oral TabletPSN4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
312138OXcarbazepine 600 MG Oral TabletPSN4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
261356Trileptal 150 MG Oral TabletPSN4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
351992Trileptal 300 MG in 5 mL Oral SuspensionPSN4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
261360Trileptal 300 MG Oral TabletPSN4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
262090Trileptal 600 MG Oral TabletPSN4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
261356oxcarbazepine 150 MG Oral Tablet [Trileptal]SBD4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
261360oxcarbazepine 300 MG Oral Tablet [Trileptal]SBD4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
351992oxcarbazepine 60 MG/ML Oral Suspension [Trileptal]SBD4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
262090oxcarbazepine 600 MG Oral Tablet [Trileptal]SBD4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
312136oxcarbazepine 150 MG Oral TabletSCD4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
312137oxcarbazepine 300 MG Oral TabletSCD4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
283536oxcarbazepine 60 MG/ML Oral SuspensionSCD4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
312138oxcarbazepine 600 MG Oral TabletSCD4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
283536oxacarbazepine 300 MG per 5 ML Oral SuspensionSY4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
261356Trileptal 150 MG Oral TabletSY4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
261360Trileptal 300 MG Oral TabletSY4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
351992Trileptal 300 MG per 5 ML Oral SuspensionSY4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
351992Trileptal 60 MG/ML Oral SuspensionSY4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
262090Trileptal 600 MG Oral TabletSY4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b39
312136OXcarbazepine 150 MG Oral TabletPSNd9741f36-0abd-49b7-9f43-e9700663122b1
312137OXcarbazepine 300 MG Oral TabletPSNd9741f36-0abd-49b7-9f43-e9700663122b1
261356Trileptal 150 MG Oral TabletPSNd9741f36-0abd-49b7-9f43-e9700663122b1
261360Trileptal 300 MG Oral TabletPSNd9741f36-0abd-49b7-9f43-e9700663122b1
261356oxcarbazepine 150 MG Oral Tablet [Trileptal]SBDd9741f36-0abd-49b7-9f43-e9700663122b1
261360oxcarbazepine 300 MG Oral Tablet [Trileptal]SBDd9741f36-0abd-49b7-9f43-e9700663122b1
312136oxcarbazepine 150 MG Oral TabletSCDd9741f36-0abd-49b7-9f43-e9700663122b1
312137oxcarbazepine 300 MG Oral TabletSCDd9741f36-0abd-49b7-9f43-e9700663122b1
261356Trileptal 150 MG Oral TabletSYd9741f36-0abd-49b7-9f43-e9700663122b1
261360Trileptal 300 MG Oral TabletSYd9741f36-0abd-49b7-9f43-e9700663122b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0337-0500078033705100 TABLET, FILM COATED in 1 BOTTLE (0078-0337-05) 2000-01-300000-00-00NoNoCurrent
0078-0337-0600078033706100 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0337-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0337-61) 100 blister pack2000-01-300000-00-00NoNoCurrent
0078-0337-61000780337611 in 1 BLISTER PACKHistorical