Home NDC 71921-411 Lacosamide Oral Solution
Product NDC 71921-411
11-digit product format 719210411
Labeler code 71921
Product ID 71921-411_4467a4df-9cd8-4d89-adfb-513e1ed3aae6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lacosamide Oral
Dosage form SOLUTION
Route ORAL
Labeler Florida Pharmaceutical Products, LLC
Application ANDA220386
Marketing category ANDA
Marketing start 2026-01-30
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 44 .
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 A220386-001 LACOSAMIDE LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2026-01-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220386-001 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 2026-10-15 13:18:30 2026-09 A220386-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2026-01-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A220386-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2026-01-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220386-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2026-01-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A220386-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2026-01-29 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220386-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2026-01-29 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LACOSAMIDE 10 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71921-411-71 Lacosamide Oral Solution 200 mL in 1 BOTTLE SOLUTION 200 2 71921-411-71 Lacosamide Oral Solution 1 in 1 CARTON SOLUTION 1 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71921-411-71 71921041171 1 BOTTLE in 1 CARTON (71921-411-71) / 200 mL in 1 BOTTLE 1 bottle 2026-01-30 No No Current