Home NDC 10135-798 Oxcarbazepine
Product NDC 10135-798
11-digit product format 101350798
Labeler code 10135
Product ID 10135-798_38688247-8bdb-ee98-e063-6294a90a8ef6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxcarbazepine
Dosage form SUSPENSION
Route ORAL
Labeler Marlex Pharmaceuticals, Inc
Application ANDA217782
Marketing category ANDA
Marketing start 2025-05-01
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 A217782-001 OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-02-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217782-001 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.
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 A217782-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-02-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217782-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-02-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217782-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-02-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217782-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-02-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217782-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-02-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217782-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-02-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217782-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-02-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217782-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-02-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217782-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-02-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217782-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-02-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217782-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-02-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217782-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-02-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217782-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-02-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217782-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-02-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217782-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-02-14 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217782-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-02-14 a50c72e98297…
Observed Orange Book normalized TE history# 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 10135-798-41 Oxcarbazepine 250 mL in 1 BOTTLE, GLASS SUSPENSION 250 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-798 OXCARBAZEPINE SUSPENSION [MARLEX PHARMACEUTICALS, INC] 1 Current NDC, 1 package rows 20250508_d3684d55-0564-4849-bdf6-b91f22a3e28c.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 10135-798-41 10135079841 250 mL in 1 BOTTLE, GLASS (10135-798-41) 250 ml 2025-05-01 No No Current