Home NDC 72189-339 OXCARBAZEPINE
Product NDC 72189-339
11-digit product format 721890339
Labeler code 72189
Product ID 72189-339_2c4c3e43-2d44-28b3-e063-6394a90a306a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OXCARBAZEPINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler DirectRx
Application ANDA077794
Marketing category ANDA
Marketing start 2022-04-05
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
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-339-60 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-339-60 0efc9e666f02…f202fb6c5f17…
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 A077794-001 OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 A077794-002 OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 A077794-003 OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09
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 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base OXCARBAZEPINE
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312136 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 72189-339-60 OXCARBAZEPINE 60 in 1 BOTTLE TABLET, FILM COATED 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-339 OXCARBAZEPINE TABLET, FILM COATED [DIRECTRX] 2 Current NDC, Legacy NDC, 1 package rows 20250123_dbea45c2-e166-b557-e053-2995a90a7643.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 1 of 1 · 2 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 72189-339-60 72189033960 60 TABLET, FILM COATED in 1 BOTTLE (72189-339-60) 2022-04-05 0000-00-00 No No Current