Home NDC 65162-649 Oxcarbazepine
Product NDC 65162-649
11-digit product format 651620649
Labeler code 65162
Product ID 65162-649_1ec65e90-ec0e-431f-a985-d7cb39694492
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxcarbazepine
Dosage form SUSPENSION
Route ORAL
Labeler Amneal Pharmaceuticals LLC
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 2026-12-31
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 · 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.
Additional Listing Data#
Finished product Yes
Brand name base Oxcarbazepine
Listing expiration 2026-12-31 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 65162-649-43 Oxcarbazepine 5 mL in 1 CUP, UNIT-DOSE SUSPENSION 5 28 65162-649-48 Oxcarbazepine 10 in 1 TRAY SUSPENSION 10 28 65162-649-78 Oxcarbazepine 1 in 1 CARTON SUSPENSION 1 28 65162-649-78 Oxcarbazepine 250 mL in 1 BOTTLE SUSPENSION 250 28
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXCARBAZEPINE ACTIVE INGREDIENT VZI5B1W380 OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 14 OXCARBAZEPINE ACTIVE MOIETY VZI5B1W380 OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 14 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 14 MALIC ACID INACTIVE INGREDIENT 817L1N4CKP OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 14 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 14 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 14 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 14 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 14 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 14 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 14 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 14 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 14 SORBITOL INACTIVE INGREDIENT 506T60A25R OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 14 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 14 WATER INACTIVE INGREDIENT 059QF0KO0R OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 14 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-649 OXCARBAZEPINE SUSPENSION [AMNEAL PHARMACEUTICALS LLC] 27 Current NDC, Legacy NDC, 4 package rows 20250227_2515391e-3a88-4226-92e5-f641c8409fe5.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 Marketing end Sample Exclude flag Status 65162-649-43 65162064943 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 65162-649-48 65162064948 10 CUP, UNIT-DOSE in 1 TRAY (65162-649-48) / 5 mL in 1 CUP, UNIT-DOSE (65162-649-43) 2012-06-04 0000-00-00 No No Current 65162-649-78 65162064978 1 BOTTLE in 1 CARTON (65162-649-78) / 250 mL in 1 BOTTLE 1 bottle 2012-06-04 0000-00-00 No No Current