Home NDC 83090-012 Lacosamide
Product NDC 83090-012
11-digit product format 830900012
Labeler code 83090
Product ID 83090-012_d122b8ed-0688-4516-92a2-4b1fa1e7fa99
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lacosamide
Dosage form INJECTION
Route INTRAVENOUS
Labeler Sintetica US LLC
Application ANDA217311
Marketing category ANDA
Marketing start 2024-03-15
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A217311-001 LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-02-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217311-001 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 2026-09-14 22:38:34 2026-08 A217311-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-02-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217311-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-02-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217311-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217311-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217311-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217311-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217311-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217311-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217311-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217311-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217311-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217311-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217311-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217311-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217311-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217311-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-02-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217311-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-02-13 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217311-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2024-02-13 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Lacosamide
Listing expiration 2027-12-31 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 83090-012-10 Lacosamide 10 in 1 CARTON INJECTION 10 2 83090-012-10 Lacosamide 20 mL in 1 VIAL, GLASS INJECTION 20 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83090-012 LACOSAMIDE INJECTION [SINTETICA US LLC] 1 Current NDC, 2 package rows 20240508_08ac486a-4f61-4e9e-9683-d1a66a6c2a4d.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 Marketing start Sample Exclude flag Status 83090-012-10 83090001210 10 VIAL, GLASS in 1 CARTON (83090-012-10) / 20 mL in 1 VIAL, GLASS 2024-03-15 No No Current