Home NDC 31722-203 LACOSAMIDE
Product NDC 31722-203
11-digit product format 317220203
Labeler code 31722
Product ID 31722-203_4f6af3bc-4950-4a6e-e063-6294a90a5ef1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LACOSAMIDE
Dosage form INJECTION
Route INTRAVENOUS
Labeler Camber Pharmaceuticals, Inc.
Application ANDA216335
Marketing category ANDA
Marketing start 2022-09-14
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 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 A216335-001 LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216335-001 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 2026-08-18 06:07:40 2026-07 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216335-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2022-09-14 a50c72e98297…
Observed Orange Book normalized TE history# 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
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 809974 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 31722-203-20 LACOSAMIDE 20 mL in 1 VIAL, GLASS INJECTION 20 5 31722-203-31 LACOSAMIDE 10 in 1 CARTON INJECTION 10 5 31722-203-32 LACOSAMIDE 20 mL in 1 VIAL, GLASS INJECTION 20 5 31722-203-33 LACOSAMIDE 10 in 1 CARTON INJECTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-203 LACOSAMIDE INJECTION [CAMBER PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 4 package rows 20231130_e24d3c45-a559-4fca-a7be-74ce37a7066e.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 Marketing end Sample Exclude flag Status 31722-203-20 31722020320 10 VIAL, GLASS in 1 CARTON (31722-203-20) > 20 mL in 1 VIAL, GLASS (31722-203-31) 2022-09-14 0000-00-00 No No Current 31722-203-31 31722020331 10 VIAL, GLASS in 1 CARTON (31722-203-31) / 20 mL in 1 VIAL, GLASS (31722-203-20) 2022-09-14 No No Current 31722-203-32 31722020332 20 mL in 1 VIAL, GLASS 20 ml Historical 31722-203-33 31722020333 10 VIAL, GLASS in 1 CARTON (31722-203-33) / 20 mL in 1 VIAL, GLASS (31722-203-32) 2022-09-14 No No Current