Home NDC 82983-427 Lacosamide Oral Solution
Product NDC 82983-427
11-digit product format 829830427
Labeler code 82983
Product ID 82983-427_9fd5f392-f470-4f19-96da-582fae4da496
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lacosamide
Dosage form SOLUTION
Route ORAL
Labeler Ajenat Pharmaceuticals LLC
Application ANDA219699
Marketing category ANDA
Marketing start 2025-07-14
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 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 A219699-001 LACOSAMIDE LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2025-06-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219699-001 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 2026-09-14 22:38:34 2026-08 A219699-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2025-06-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219699-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2025-06-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219699-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2025-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219699-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2025-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219699-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2025-06-26 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219699-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2025-06-26 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 Oral Solution
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 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 82983-427-31 Lacosamide Oral Solution 200 mL in 1 BOTTLE, PLASTIC SOLUTION 200 2
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 · 4 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 82983-427-31 82983042731 200 mL in 1 BOTTLE, PLASTIC (82983-427-31) 200 ml 2025-07-14 No No Current