Home NDC 0078-0357-52 Trileptal
Product NDC 0078-0357
Requested package NDC 0078-0357-52
11-digit product format 000780357
Labeler code 0078
Product ID 0078-0357_1d3c2f8f-ee02-4be8-8e48-77defb000901
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxcarbazepine
Dosage form SUSPENSION
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA021285
Marketing category NDA
Marketing start 2001-05-30
Substance OXCARBAZEPINE
Active strength 60 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021285-001 TRILEPTAL OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021285-001 AB
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 2 · 44 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 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021285-001 8119148 2020-12-19 U-724 Drug product 2012-03-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021285-001 8119148*PED 2021-06-19 Pediatric extension 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021285-001 8119148*PED 2021-06-19 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021285-001 8119148*PED 2021-06-19 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021285-001 8119148*PED 2021-06-19 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021285-001 8119148 2020-12-19 U-724 Drug product 2012-03-08 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021285-001 8119148*PED 2021-06-19 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021285-001 8119148 2020-12-19 U-724 Drug product 2012-03-08 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021285-001 8119148*PED 2021-06-19 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021285-001 8119148 2020-12-19 U-724 Drug product 2012-03-08 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021285-001 8119148*PED 2021-06-19 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021285-001 8119148 2020-12-19 U-724 Drug product 2012-03-08 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021285-001 8119148*PED 2021-06-19 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021285-001 8119148 2020-12-19 U-724 Drug product 2012-03-08 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021285-001 8119148*PED 2021-06-19 Pediatric extension ea99ee380514…
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 60 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0078-0357-52 Trileptal 250 mL in 1 BOTTLE SUSPENSION 250 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 0078-0357 TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 37 Current NDC, Legacy NDC, 1 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 0078-0357-52 00078035752 250 mL in 1 BOTTLE (0078-0357-52) 250 ml 2001-05-30 0000-00-00 No No Current