Home NDC 0121-1012 Lacosamide
Product NDC 0121-1012
11-digit product format 001211012
Labeler code 0121
Product ID 0121-1012_18c9996c-d931-4bc4-9c36-f1a7c128a635
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lacosamide
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA216151
Marketing category ANDA
Marketing start 2022-08-26
Substance LACOSAMIDE
Active strength 50 mg/5mL
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 A216151-001 LACOSAMIDE LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216151-001 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 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216151-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-08-26 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LACOSAMIDE 50 mg/5mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0121-1012-05 Lacosamide 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 22 0121-1012-95 Lacosamide 10 in 1 TRAY SOLUTION 10 22 0121-1012-95 Lacosamide 1 in 1 CASE SOLUTION 1 22
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-1012 LACOSAMIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] 22 Current NDC, 3 package rows 20240601_75de00d8-d2e7-4025-be4e-f49299068e7e.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 Units Marketing start Sample Exclude flag Status 0121-1012-05 00121101205 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 0121-1012-95 00121101295 1 TRAY in 1 CASE (0121-1012-95) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1012-05) 1 tray 2023-04-28 No No Current