Home NDC 0121-3968-95 Lacosamide
Product NDC 0121-3968
Requested package NDC 0121-3968-95
11-digit product format 001213968
Labeler code 0121
Product ID 0121-3968_a95d174d-efee-4ba5-8734-9adaad16be27
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lacosamide
Dosage form SOLUTION
Route ORAL
Labeler PAI
Application ANDA209301
Marketing category ANDA
Marketing start 2022-05-31
Marketing end 0000-00-00
Substance LACOSAMIDE
Active strength 200 mg/20mL
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE]
DEA schedule CV
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A209301-001 LACOSAMIDE LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209301-001 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 2026-08-18 06:07:40 2026-07 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209301-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-31 a50c72e98297…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0121-3968-74 Lacosamide 20 mL in 1 CUP, UNIT-DOSE SOLUTION 20 22 0121-3968-95 Lacosamide 1 in 1 CASE SOLUTION 1 22 0121-3968-95 Lacosamide 10 in 1 TRAY SOLUTION 10 22
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-3968 LACOSAMIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] 22 Legacy 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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0121-3968-95 00121396895 1 TRAY in 1 CASE (0121-3968-95) > 10 CUP, UNIT-DOSE in 1 TRAY > 20 mL in 1 CUP, UNIT-DOSE (0121-3968-74) 1 tray 2022-11-01 0000-00-00 No No Current