Home NDC 70518-1842-3 Oxcarbazepine
Product NDC 70518-1842
Requested package NDC 70518-1842-3
11-digit product format 705181842
Labeler code 70518
Product ID 70518-1842_f1db72e1-5b86-3dd4-e053-2a95a90af4ea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxcarbazepine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA077794
Marketing category ANDA
Marketing start 2019-02-01
Marketing end 0000-00-00
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 2024-12-31
Current FDA listing Historical FDA.report record 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-1842 70518-1842-3 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-1842 70518-1842-3 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-1842 OXCARBAZEPINE TABLET, FILM COATED [REMEDYREPACK INC.] 11 Legacy NDC 20250302_d4737be8-7c17-4548-b380-808c5b4ad7ac.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70518-1842-3 70518184203 100 POUCH in 1 BOX (70518-1842-3) > 1 TABLET, FILM COATED in 1 POUCH (70518-1842-4) 100 pouch 2023-01-07 0000-00-00 No No Current