Home NDC 60429-062 OXCARBAZEPINE
Product NDC 60429-062
11-digit product format 604290062
Labeler code 60429
Product ID 60429-062_45b3173c-282f-9856-e063-6394a90abdf2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OXCARBAZEPINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA078069
Marketing category ANDA
Marketing start 2008-01-11
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 2026-12-31
Current FDA listing Yes 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
Additional Listing Data#
Finished product Yes
Brand name base OXCARBAZEPINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXCARBAZEPINE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VZI5B1W380 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312136 Internal RxNorm lookup 312137 Internal RxNorm lookup 312138 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60429-062-01 OXCARBAZEPINE 100 in 1 BOTTLE TABLET, FILM COATED 100 18 60429-062-05 OXCARBAZEPINE 500 in 1 BOTTLE TABLET, FILM COATED 500 18 60429-062-18 OXCARBAZEPINE 180 in 1 BOTTLE TABLET, FILM COATED 180 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXCARBAZEPINE ACTIVE INGREDIENT VZI5B1W380 OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] 3 OXCARBAZEPINE ACTIVE MOIETY VZI5B1W380 OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] 3 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] 3 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] 3 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] 3 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60429-062 OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 17 Current NDC, Legacy NDC, 3 package rows 20240124_b9db5c45-8b51-449b-b4af-1a235c08f189.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 2 of 2 · 21 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60429-062-01 60429006201 100 TABLET, FILM COATED in 1 BOTTLE (60429-062-01) 2013-04-11 0000-00-00 No No Current 60429-062-05 60429006205 500 TABLET, FILM COATED in 1 BOTTLE (60429-062-05) 2019-09-10 0000-00-00 No No Current 60429-062-18 60429006218 180 TABLET, FILM COATED in 1 BOTTLE (60429-062-18) 2015-01-09 0000-00-00 No No Current