Home NDC 63629-4987-4 Oxcarbazepine
Product NDC 63629-4987
Requested package NDC 63629-4987-4
11-digit product format 636294987
Labeler code 63629
Product ID 63629-4987_9530c23e-7f67-492c-b00c-a17092a5387e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxcarbazepine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA077794
Marketing category ANDA
Marketing start 2007-10-09
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 · 13 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
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.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-4987-1 2024-05-16 These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000 63629-4987-2 2024-05-16 These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000 63629-4987-3 2024-05-16 These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000 63629-4987-4 2024-05-16 These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000 63629-4987-5 2024-05-16 These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000 63629-4987-1 2024-01-30 These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000 63629-4987-2 2024-01-30 These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000 63629-4987-3 2024-01-30 These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000 63629-4987-4 2024-01-30 These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000 63629-4987-5 2024-01-30 These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. OXCARBAZEPINE tablets, for oral use Initial U.S. Approval: 2000
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXCARBAZEPINE ACTIVE INGREDIENT VZI5B1W380 OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 OXCARBAZEPINE ACTIVE MOIETY VZI5B1W380 OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63629-4987-4 63629498704 180 TABLET, FILM COATED in 1 BOTTLE (63629-4987-4) 2022-02-02 0000-00-00 No No Current