Home NDC 0904-7262 OXCARBAZEPINE
Product NDC 0904-7262
11-digit product format 009047262
Labeler code 0904
Product ID 0904-7262_5b0a7e96-17ac-4329-9a52-5e0ddab821db
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OXCARBAZEPINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA078069
Marketing category ANDA
Marketing start 2022-11-07
Marketing end 2027-08-31
Substance OXCARBAZEPINE
Active strength 150 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Current FDA listing Yes 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 Active Ingredients# Ingredient, Strength table Ingredient Strength OXCARBAZEPINE 150 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 0904-7262-61 OXCARBAZEPINE 100 in 1 CARTON TABLET, FILM COATED 100 4 0904-7262-61 OXCARBAZEPINE 1 in 1 BLISTER PACK TABLET, FILM COATED 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7262 OXCARBAZEPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 2 Current NDC, Legacy NDC, 2 package rows 20240816_b1d54def-057d-4608-bc8f-1d967ac3ec91.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 Units Marketing start Marketing end Sample Exclude flag Status 0904-7262-61 00904726261 100 BLISTER PACK in 1 CARTON (0904-7262-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK 100 blister pack 2022-11-07 2027-08-31 No No Current