Home NDC 68462-697-30 LACOSAMIDE
Product NDC 68462-697
Requested package NDC 68462-697-30
11-digit product format 684620697
Labeler code 68462
Product ID 68462-697_bc7ed8a6-acce-48f2-9ef1-4e366c71dbbc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LACOSAMIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler GLENMARK PHARMACEUTICALS INC., USA
Application ANDA220268
Marketing category ANDA
Marketing start 2026-03-16
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 1 .
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 A220268-001 LACOSAMIDE LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2026-01-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220268-001 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 2026-02-19 14:30 UTC 2026-02 A220268-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2026-01-21 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220268-001 LACOSAMIDE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS AP 2026-01-21 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A220268-001 AP 1 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220268-001 AP 1 a50c72e98297…
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 68462-697-20 LACOSAMIDE 20 mL in 1 VIAL INJECTION, SOLUTION 20 1 68462-697-30 LACOSAMIDE 10 in 1 CARTON INJECTION, SOLUTION 10 1
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 Sample Exclude flag Status 68462-697-30 68462069730 10 VIAL in 1 CARTON (68462-697-30) / 20 mL in 1 VIAL (68462-697-20) 10 vial 2026-03-16 No No Current