Home NDC 50268-649-12 Oxcarbazepine
Product NDC 50268-649
Requested package NDC 50268-649-12
11-digit product format 502680649
Labeler code 50268
Product ID 50268-649_ed85a3c4-5221-9051-e053-2a95a90a703b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxcarbazepine
Dosage form SUSPENSION
Route ORAL
Labeler AvPAK
Application ANDA202961
Marketing category ANDA
Marketing start 2021-06-14
Marketing end 0000-00-00
Substance OXCARBAZEPINE
Active strength 300 mg/5mL
Pharmacologic classes Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202961-001 OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202961-001 AB
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 · 41 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 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50268-649-05 Oxcarbazepine 5 mL in 1 CUP, UNIT-DOSE SUSPENSION 5 2 50268-649-30 Oxcarbazepine 30 in 1 TRAY SUSPENSION 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-649 OXCARBAZEPINE SUSPENSION [AVPAK] 2 Legacy NDC, 2 package rows 20230419_f89a012f-3c0c-5b80-e053-6394a90ad99f.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 · 3 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 50268-649-12 50268064912 20 CUP, UNIT-DOSE in 1 BOX (50268-649-12) > 5 mL in 1 CUP, UNIT-DOSE (50268-649-11) 2021-06-14 0000-00-00 No No Current