Home NDC 55289-007-30 Trileptal
Product NDC 55289-007
Requested package NDC 55289-007-30
11-digit product format 552890007
Labeler code 55289
Product ID 55289-007_d83ed50a-ec21-4b28-e053-2995a90a0017
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxcarbazepine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA021014
Marketing category NDA
Marketing start 2000-01-30
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 No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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-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 · 123 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 2026-02-19 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…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021014-002 TRILEPTAL 300MG TABLET / ORAL AB RLD 2000-01-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021014-003 TRILEPTAL 600MG TABLET / ORAL AB RLD, RS 2000-01-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021014-001 TRILEPTAL 150MG TABLET / ORAL AB RLD 2000-01-14 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXCARBAZEPINE ACTIVE INGREDIENT VZI5B1W380 TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 OXCARBAZEPINE ACTIVE MOIETY VZI5B1W380 TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 TALC INACTIVE INGREDIENT 7SEV7J4R1U TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Trileptal OXCARBAZEPINE Novartis Pharmaceuticals Corporation 4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b 2025-12-16 Warnings, Adverse reactions Exact identifier application applno (NDA): 021014 application number: NDA021014
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55289-007-30 55289000730 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-007-30) 2011-03-17 0000-00-00 No No Current