Home NDC 0904-7463 Lacosamide
Product NDC 0904-7463
11-digit product format 009047463
Labeler code 0904
Product ID 0904-7463_6e6658af-c86d-4c22-8bd1-3c36e7cece85
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lacosamide
Dosage form SOLUTION
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA216151
Marketing category ANDA
Marketing start 2023-04-28
Substance LACOSAMIDE
Active strength 50 mg/5mL
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA schedule CV
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 42 .
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 A216151-001 LACOSAMIDE LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216151-001 AA
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 2026-08-18 06:07:40 2026-07 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Lacosamide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LACOSAMIDE 50 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 563KS2PQY5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 993856 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 0904-7463-41 Lacosamide 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 16 0904-7463-68 Lacosamide 10 in 1 TRAY SOLUTION 10 16 0904-7463-68 Lacosamide 1 in 1 CASE SOLUTION 1 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7463 LACOSAMIDE SOLUTION [MAJOR PHARMACEUTICALS] 14 Current NDC, 3 package rows 20250130_973cea8d-e516-4014-a116-c5990554a550.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 0904-7463-41 00904746341 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 0904-7463-68 00904746368 1 TRAY in 1 CASE (0904-7463-68) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7463-41) 1 tray 2023-04-28 No No Current