Home NDC 72888-461-01 Oxcarbazepine
Product NDC 72888-461
Requested package NDC 72888-461-01
11-digit product format 728880461
Labeler code 72888
Product ID 72888-461_49fe26b4-1dcb-832f-e063-6294a90a6195
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxcarbazepine
Dosage form TABLET
Route ORAL
Labeler Advagen Pharma Ltd.
Application ANDA207717
Marketing category ANDA
Marketing start 2025-05-20
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 2027-12-31
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 A207717-001 OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 A207717-002 OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 A207717-003 OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05
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 2 · 54 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 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207717-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2024-03-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207717-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2024-03-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207717-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2024-03-05 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXCARBAZEPINE 600 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 72888-461-01 Oxcarbazepine 500 in 1 BOTTLE TABLET 500 2 72888-461-02 Oxcarbazepine 100 in 1 BOTTLE TABLET 100 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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72888-461-01 72888046101 500 TABLET in 1 BOTTLE (72888-461-01) 500 tablet 2025-05-20 No No Current