Home NDC 67877-732 Lacosamide Oral Solution
Product NDC 67877-732
11-digit product format 678770732
Labeler code 67877
Product ID 67877-732_c4d07291-0152-4092-a339-3edee132ef09
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lacosamide Oral Solution
Dosage form SOLUTION
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA214672
Marketing category ANDA
Marketing start 2022-05-20
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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214672-001 LACOSAMIDE LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214672-001 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 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214672-001 LACOSAMIDE 10MG/ML SOLUTION / ORAL AA 2022-05-19 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Lacosamide Oral Solution
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LACOSAMIDE 10 mg/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 993856 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 67877-732-95 Lacosamide Oral Solution 200 mL in 1 BOTTLE SOLUTION 200 20 67877-732-97 Lacosamide Oral Solution 465 mL in 1 BOTTLE SOLUTION 465 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-732 LACOSAMIDE ORAL SOLUTION SOLUTION [ASCEND LABORATORIES, LLC] 19 Current NDC, Legacy NDC, 2 package rows 20240831_4ae87834-05d8-43c8-aaa3-78047d4a573c.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 Units Marketing start Marketing end Sample Exclude flag Status 67877-732-95 67877073295 200 mL in 1 BOTTLE (67877-732-95) 200 ml 2022-05-20 0000-00-00 No No Current 67877-732-97 67877073297 465 mL in 1 BOTTLE (67877-732-97) 465 ml 2022-05-20 0000-00-00 No No Current