Home NDC 51672-4107-3 Oxcarbazepine
Product NDC 51672-4107
Requested package NDC 51672-4107-3
11-digit product format 516724107
Labeler code 51672
Product ID 51672-4107_802f2425-e2a0-483a-8378-6c579e7738a2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxcarbazepine
Dosage form TABLET
Route ORAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA077801
Marketing category ANDA
Marketing start 2007-11-15
Marketing end 0000-00-00
Substance OXCARBAZEPINE
Active strength 600 mg/1
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 · 1 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 package package 51672-4107 51672-4107-3 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 A077801-001 OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-11-15 A077801-002 OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-11-15 A077801-003 OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-11-15
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 A077801-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-11-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077801-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-11-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077801-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-11-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077801-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077801-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077801-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077801-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077801-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077801-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077801-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077801-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077801-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077801-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077801-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077801-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077801-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077801-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077801-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077801-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077801-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077801-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077801-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-11-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077801-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-11-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077801-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077801-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-11-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077801-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-11-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077801-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077801-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-11-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077801-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-11-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077801-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077801-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-11-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077801-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-11-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077801-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077801-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-11-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077801-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-11-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077801-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077801-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-11-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077801-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-11-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077801-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077801-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-11-15 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 [TARO PHARMACEUTICALS U.S.A., INC.] 6 Oxcarbazepine ACTIVE MOIETY VZI5B1W380 OXCARBAZEPINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 6 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 OXCARBAZEPINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 6 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 OXCARBAZEPINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 6 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT OXCARBAZEPINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 6 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO OXCARBAZEPINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 6 magnesium stearate INACTIVE INGREDIENT 70097M6I30 OXCARBAZEPINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 6 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 OXCARBAZEPINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4107 OXCARBAZEPINE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] 8 Legacy NDC 20241212_17325a80-fb9c-4a83-b4b4-98e0b999d852.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-4107-3 51672410703 1000 TABLET in 1 BOTTLE (51672-4107-3) 1000 tablet 2007-11-15 0000-00-00 No No Current