Home NDC 65219-204 Lacosamide
Product NDC 65219-204
11-digit product format 652190204
Labeler code 65219
Product ID 65219-204_0f09367f-3191-41f4-891c-abdd7ed3cecd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lacosamide
Dosage form INJECTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA214677
Marketing category ANDA
Marketing start 2022-07-25
Substance LACOSAMIDE
Active strength 10 mg/mL
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 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 A214677-001 LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214677-001 AP
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 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214677-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-03 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 10 mg/mL
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 809974 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 65219-204-01 Lacosamide 20 mL in 1 VIAL, SINGLE-DOSE INJECTION 20 3 65219-204-20 Lacosamide 10 in 1 CARTON INJECTION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-204 LACOSAMIDE INJECTION [FRESENIUS KABI USA, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20250215_419ff519-2b19-4fb9-adfa-868ba0229407.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 · 1 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 65219-204-01 65219020401 20 mL in 1 VIAL, SINGLE-DOSE 20 ml Historical 65219-204-20 65219020420 10 VIAL, SINGLE-DOSE in 1 CARTON (65219-204-20) / 20 mL in 1 VIAL, SINGLE-DOSE (65219-204-01) 2022-07-25 0000-00-00 No No Current