Home NDC 33261-684 Oxcarbazepine
Product NDC 33261-684
11-digit product format 332610684
Labeler code 33261
Product ID 33261-684_c432adf9-17a7-4c67-8488-0c67c6185103
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxcarbazepine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aidarex Pharmaceuticals LLC
Application ANDA077794
Marketing category ANDA
Marketing start 2007-10-09
Marketing end 0000-00-00
Substance OXCARBAZEPINE
Active strength 150 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag E
Listing certified through 2018-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 33261-684-90 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 33261-684-90 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 33261-684-90 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 33261-684-90 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 33261-684-90 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 33261-684-90 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 33261-684-90 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 33261-684-90 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 33261-684-90 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 33261-684-90 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 33261-684-90 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 33261-684-90 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 33261-684-90 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 33261-684-90 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 33261-684-90 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 33261-684-90 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 33261-684-90 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 33261-684-90 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 33261-684-90 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 33261-684-90 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 33261-684-90 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 33261-684-90 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A077794-001 OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 A077794-002 OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 A077794-003 OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09
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 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33261-684-90 Oxcarbazepine 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXCARBAZEPINE ACTIVE INGREDIENT VZI5B1W380 OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 OXCARBAZEPINE ACTIVE MOIETY VZI5B1W380 OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33261-684 OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 Legacy NDC, 1 package rows 20140128_abbf6b75-bc22-42af-ae08-445d8c186092.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 33261-684-90 33261068490 90 in 1 BOTTLE, PLASTIC Historical