Home NDC 68084-853 Oxcarbazepine
Product NDC 68084-853
11-digit product format 680840853
Labeler code 68084
Product ID 68084-853_ea3fda1e-efeb-6d95-e053-2995a90adada
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxcarbazepine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler American Health Packaging
Application ANDA078069
Marketing category ANDA
Marketing start 2014-11-05
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 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68084-853-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68084-853-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68084-853-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68084-853-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68084-853-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68084-853-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68084-853-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68084-853-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68084-853-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68084-853-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68084-853-01 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A078069-001 OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 A078069-002 OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 A078069-003 OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11
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 · 129 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 2026-09-14 22:38:34 2026-08 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXCARBAZEPINE ACTIVE INGREDIENT VZI5B1W380 OXCARBAZEPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 OXCARBAZEPINE ACTIVE MOIETY VZI5B1W380 OXCARBAZEPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 OXCARBAZEPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXCARBAZEPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK OXCARBAZEPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK OXCARBAZEPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M OXCARBAZEPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 OXCARBAZEPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO OXCARBAZEPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 OXCARBAZEPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXCARBAZEPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A OXCARBAZEPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 OXCARBAZEPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 OXCARBAZEPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U OXCARBAZEPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OXCARBAZEPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 2
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 2 of 2 · 21 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68084-853-01 68084085301 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-853-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-853-11) 100 blister pack 2014-11-05 0000-00-00 No No Current