Home NDC 0615-8635 Oxcarbazepine
Product NDC 0615-8635
11-digit product format 006158635
Labeler code 0615
Product ID 0615-8635_ad0a4e51-2bd3-4291-88bd-804083ae618b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxcarbazepine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NCS HealthCare of KY, LLC dba Vangard Labs
Application ANDA078005
Marketing category ANDA
Marketing start 2025-07-15
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 2027-12-31
Current FDA listing Yes 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 A078005-001 OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-12-11 A078005-002 OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-12-11 A078005-003 OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-12-11
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 · 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 A078005-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078005-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078005-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-12-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078005-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078005-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078005-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-12-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078005-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-12-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078005-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-12-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078005-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-12-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078005-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-12-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078005-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-12-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078005-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-12-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078005-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-12-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078005-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-12-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078005-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-12-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078005-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-12-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078005-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-12-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078005-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-12-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078005-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-12-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078005-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-12-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078005-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-12-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078005-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-12-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078005-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-12-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078005-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-12-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078005-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-12-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078005-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-12-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078005-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-12-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078005-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-12-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078005-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-12-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078005-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-12-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078005-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-12-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078005-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-12-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078005-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-12-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078005-001 OXCARBAZEPINE 150MG TABLET / ORAL 2007-12-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078005-002 OXCARBAZEPINE 300MG TABLET / ORAL 2007-12-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078005-003 OXCARBAZEPINE 600MG TABLET / ORAL 2007-12-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078005-001 OXCARBAZEPINE 150MG TABLET / ORAL 2007-12-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078005-002 OXCARBAZEPINE 300MG TABLET / ORAL 2007-12-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078005-003 OXCARBAZEPINE 600MG TABLET / ORAL 2007-12-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078005-001 OXCARBAZEPINE 150MG TABLET / ORAL 2007-12-11 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Oxcarbazepine
Listing expiration 2027-12-31 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 0615-8635-39 Oxcarbazepine 30 in 1 BLISTER PACK TABLET, FILM COATED 30 1
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0615-8635-39 00615863539 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8635-39) 2026-05-12 No No Current