Home NDC 72162-2088 Oxcarbazepine
Product NDC 72162-2088
11-digit product format 721622088
Labeler code 72162
Product ID 72162-2088_607d508f-f96b-46e1-94ff-985d355b4c61
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxcarbazepine
Dosage form SUSPENSION
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA202961
Marketing category ANDA
Marketing start 2012-06-04
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 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 · 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 · 43 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 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202961-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2012-09-17 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 300 mg/5mL
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 283536 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 72162-2088-2 Oxcarbazepine 250 mL in 1 BOTTLE SUSPENSION 250 102 72162-2088-2 Oxcarbazepine 1 in 1 CARTON SUSPENSION 1 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-2088 OXCARBAZEPINE SUSPENSION [BRYANT RANCH PREPACK] 101 Current NDC, 2 package rows 20250406_148b90ba-236a-47cc-b171-22dd7f8f8e0a.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 Units Marketing start Sample Exclude flag Status 72162-2088-2 72162208802 1 BOTTLE in 1 CARTON (72162-2088-2) / 250 mL in 1 BOTTLE 1 bottle 2012-06-04 No No Current