Home NDC 82804-993-78 Lacosamide
Product NDC 82804-993
Requested package NDC 82804-993-78
11-digit product format 828040993
Labeler code 82804
Product ID 82804-993_47ae2f1f-d135-4f4e-acc2-500c1afa7b8b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lacosamide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA205237
Marketing category ANDA
Marketing start 2023-07-10
Substance LACOSAMIDE
Active strength 200 mg/1
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205237-001 LACOSAMIDE LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 A205237-002 LACOSAMIDE LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 A205237-003 LACOSAMIDE LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 A205237-004 LACOSAMIDE LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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.
Product history page 1 of 4 · 128 observed 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 A205237-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205237-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205237-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205237-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205237-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205237-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205237-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205237-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205237-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205237-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205237-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205237-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205237-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205237-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205237-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205237-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205237-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205237-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205237-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205237-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205237-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205237-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205237-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205237-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205237-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205237-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205237-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205237-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205237-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205237-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205237-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205237-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205237-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205237-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205237-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205237-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205237-001 LACOSAMIDE 50MG TABLET / ORAL AB 2022-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205237-002 LACOSAMIDE 100MG TABLET / ORAL AB 2022-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205237-003 LACOSAMIDE 150MG TABLET / ORAL AB 2022-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205237-004 LACOSAMIDE 200MG TABLET / ORAL AB 2022-03-17 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 128 observed states.
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 200 mg/1
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 809987 Internal RxNorm lookup 809992 Internal RxNorm lookup 809996 Internal RxNorm lookup 810000 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 82804-993-00 Lacosamide 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 1 82804-993-11 Lacosamide 1000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1000 1 82804-993-30 Lacosamide 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 1 82804-993-55 Lacosamide 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 1 82804-993-60 Lacosamide 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 1 82804-993-64 Lacosamide 240 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 240 1 82804-993-72 Lacosamide 120 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 120 1 82804-993-78 Lacosamide 180 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 180 1 82804-993-90 Lacosamide 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82804-993 LACOSAMIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 Current NDC, 9 package rows 20240523_47ae2f1f-d135-4f4e-acc2-500c1afa7b8b.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 Marketing start Sample Exclude flag Status 82804-993-78 82804099378 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-993-78) 2024-05-21 No No Current