Home NDC 0781-6270 Oxcarbazepine
Product NDC 0781-6270
11-digit product format 007816270
Labeler code 0781
Product ID 0781-6270_06fea264-7ef7-4b5d-a772-b5d2d016efc2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oxcarbazepine
Dosage form SUSPENSION
Route ORAL
Labeler Sandoz Inc
Application NDA021285
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2001-05-30
Marketing end 0000-00-00
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 2021-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 0781-6270 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0781-6270 0781-6270-43 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 41 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 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…2022-10-28 04:53 UTC 2022-10 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021285-001 TRILEPTAL 300MG/5ML SUSPENSION / ORAL AB RLD, RS 2001-05-25 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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…
DailyMed Product Concepts# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-6270 OXCARBAZEPINE SUSPENSION [SANDOZ INC] 8 Legacy NDC 20230714_1ccdb12e-3c52-4fb4-a2db-aeb8ca5757f7.zip
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): 021285 application number: NDA021285
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0781-6270-43 00781627043 250 mL in 1 BOTTLE (0781-6270-43) 250 ml 2001-05-30 0000-00-00 No No Current