Home NDC 29300-367 Lacosamide
Product NDC 29300-367
11-digit product format 293000367
Labeler code 29300
Product ID 29300-367_d452fee5-4940-4740-8c4d-8024788eafc6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lacosamide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Unichem Pharmaceuticals (USA), Inc.
Application ANDA213109
Marketing category ANDA
Marketing start 2024-12-01
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A213109-001 LACOSAMIDE LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 A213109-002 LACOSAMIDE LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 A213109-003 LACOSAMIDE LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 A213109-004 LACOSAMIDE LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04
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 2 · 48 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 2026-08-18 06:07:40 2026-07 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213109-001 LACOSAMIDE 50MG TABLET / ORAL AB 2024-09-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213109-002 LACOSAMIDE 100MG TABLET / ORAL AB 2024-09-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213109-003 LACOSAMIDE 150MG TABLET / ORAL AB 2024-09-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213109-004 LACOSAMIDE 200MG TABLET / ORAL AB 2024-09-04 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lacosamide
Listing expiration 2026-12-31 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 29300-367-05 Lacosamide 500 in 1 BOTTLE TABLET, FILM COATED 500 6 29300-367-16 Lacosamide 60 in 1 BOTTLE TABLET, FILM COATED 60 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 29300-367 LACOSAMIDE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] 6 Current NDC, 2 package rows 20241202_7ed5cebe-470e-48a4-86ec-2ce79cc32688.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 29300-367-05 29300036705 500 TABLET, FILM COATED in 1 BOTTLE (29300-367-05) 2024-12-01 No No Current 29300-367-16 29300036716 60 TABLET, FILM COATED in 1 BOTTLE (29300-367-16) 2024-12-01 No No Current