Home NDC 0078-0457 Trileptal
Product NDC 0078-0457
11-digit product format 000780457
Labeler code 0078
Product ID 0078-0457_1d3c2f8f-ee02-4be8-8e48-77defb000901
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 600 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021014-001 TRILEPTAL OXCARBAZEPINE 150MG TABLET / ORAL AB RLD 2000-01-14 N021014-002 TRILEPTAL OXCARBAZEPINE 300MG TABLET / ORAL AB RLD 2000-01-14 N021014-003 TRILEPTAL OXCARBAZEPINE 600MG TABLET / ORAL AB RLD, RS 2000-01-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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.
Product history page 1 of 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Trileptal
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXCARBAZEPINE 600 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0078-0457-05 Trileptal 100 in 1 BOTTLE TABLET, FILM COATED 100 39 0078-0457-35 Trileptal 100 in 1 BOX, UNIT-DOSE TABLET, FILM COATED 100 39 0078-0457-61 Trileptal 1 in 1 BLISTER PACK TABLET, FILM COATED 1 39
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXCARBAZEPINE ACTIVE INGREDIENT VZI5B1W380 TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 OXCARBAZEPINE ACTIVE MOIETY VZI5B1W380 TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 ALCOHOL INACTIVE INGREDIENT 3K9958V90M TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 LEMON INACTIVE INGREDIENT 24RS0A988O TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 PLUM INACTIVE INGREDIENT 67M3EQ6BE1 TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 SORBIC ACID INACTIVE INGREDIENT X045WJ989B TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 SORBITOL INACTIVE INGREDIENT 506T60A25R TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 TALC INACTIVE INGREDIENT 7SEV7J4R1U TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20 WATER INACTIVE INGREDIENT 059QF0KO0R TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0457 TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 37 Current NDC, Legacy NDC, 3 package rows 20250122_4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-0457-05 00078045705 100 TABLET, FILM COATED in 1 BOTTLE (0078-0457-05) 2000-01-30 0000-00-00 No No Current 0078-0457-35 00078045735 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0457-35) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0457-61) 100 blister pack 2000-01-30 0000-00-00 No No Current 0078-0457-61 00078045761 1 in 1 BLISTER PACK Historical