Home NDC 25021-791 LACOSAMIDE
Product NDC 25021-791
11-digit product format 250210791
Labeler code 25021
Product ID 25021-791_7806202c-6252-46c3-af44-c0919f49fd1e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LACOSAMIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA214301
Marketing category ANDA
Marketing start 2022-03-17
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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214301-001 LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214301-001 AP
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 2026-09-14 22:38:34 2026-08 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214301-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-07 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 10 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 25021-791-20 LACOSAMIDE 10 in 1 CARTON INJECTION, SOLUTION 10 7 25021-791-20 LACOSAMIDE 20 mL in 1 VIAL, GLASS INJECTION, SOLUTION 20 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-791 LACOSAMIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 7 Current NDC, Legacy NDC, 2 package rows 20240711_6b4536d0-5703-42b0-9f59-46a3e1b75b22.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 Marketing end Sample Exclude flag Status 25021-791-20 25021079120 10 VIAL, GLASS in 1 CARTON (25021-791-20) / 20 mL in 1 VIAL, GLASS 2022-03-17 0000-00-00 No No Current