Home NDC 60290-069 Oxcarbazepine
Product NDC 60290-069
11-digit product format 602900069
Labeler code 60290
Product ID 60290-069_5111d6a1-5399-6f6b-e063-6294a90a6124
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxcarbazepine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Umedica Laboratories USA Inc.
Application ANDA218341
Marketing category ANDA
Marketing start 2026-01-01
Substance OXCARBAZEPINE
Active strength 600 mg/1
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 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 A218341-001 OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET / ORAL AB 2026-04-29 A218341-002 OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET / ORAL AB 2026-04-29 A218341-003 OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET / ORAL AB 2026-04-29
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.
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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218341-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2026-04-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218341-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2026-04-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218341-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2026-04-29 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218341-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218341-002 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218341-003 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Oxcarbazepine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXCARBAZEPINE 600 mg/1
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312136 Internal RxNorm lookup 312137 Internal RxNorm lookup 312138 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 60290-069-01 Oxcarbazepine 100 in 1 BOTTLE TABLET, FILM COATED 100 1 60290-069-02 Oxcarbazepine 500 in 1 BOTTLE TABLET, FILM COATED 500 1
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 60290-069-01 60290006901 100 TABLET, FILM COATED in 1 BOTTLE (60290-069-01) 2026-01-01 No No Current 60290-069-02 60290006902 500 TABLET, FILM COATED in 1 BOTTLE (60290-069-02) 2026-01-01 No No Current