FDA.reportPublic FDA data

NDC 0121-1012-05 - Lacosamide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0121-1012
Requested NDC
0121-1012-05
Package NDCs from labels
0121-1012-05, 0121-1012-95, 0121-1012-94
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Effective date
2026-04-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lacosamide - PAI Holdings, LLC dba PAI PharmaPAI Holdings, LLC dba PAI Pharma2026-04-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-1012-05Lacosamide5 mL in 1 CUP, UNIT-DOSESOLUTION522
0121-1012-95Lacosamide10 in 1 TRAYSOLUTION1022
0121-1012-95Lacosamide1 in 1 CASESOLUTION122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1012LACOSAMIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]22Current NDC, 3 package rows20240601_75de00d8-d2e7-4025-be4e-f49299068e7e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1012-05ML - Milliliter0121-10120550a7aa-39ed-4350-931e-796e0654784412023-05-05
0121-1012-95ML - Milliliter0121-1012e341afa4-3085-4835-9602-45d19dedf4b312023-05-05

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 47 of 218 · 4,341 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALCOHOL PREP AWABSISOPROPYL ALCOHOL PATCHHenan Bingqing Yujie wipes Co., LTD2e67e417-4dba-73a2-e063-6294a90aa4b22026-03-20WarningsExact identifier
unii: 3K9958V90M
SODIUM CHLORIDE HYPERTONICITYSODIUM CHLORIDEYYBA CORP439653b9-99b8-4799-8d67-4a2ada9c67832026-03-20WarningsExact identifier
unii: 451W47IQ8X
Smart Care SQUISHMALLOWS SWEET PEA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.50ed03d9-88d1-4930-9c7d-62082bf8ce952026-03-20WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER MADRID MUSEALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5cecf6-c232-6cd9-e063-6394a90a03e92026-03-19WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER VALENCIA VIBESALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5de4d6-4c58-f393-e063-6294a90a323a2026-03-19WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER MALLORCA BREEZEALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5e50de-62fd-f9e9-e063-6394a90af0bd2026-03-19WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER MAR BELLAALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d6005d9-5d4d-033e-e063-6294a90ad36f2026-03-19WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
hand sanitizerHAND SANITIZERShenzhen yuehaotong Technology Co., Ltd4d482f95-e192-3fef-e063-6294a90a6a402026-03-18WarningsExact identifier
unii: 3K9958V90M
Avant 70% Alcohol GelALCOHOLB4 Soap LLC241f4334-2e88-4f7b-a0c7-c93da9f5086c2026-03-18WarningsExact identifier
unii: 3K9958V90M
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 PercentSODIUM CHLORIDEAltaire Pharmaceuticals Inc.e13fd053-9420-490c-a43e-e14b0930cb4e2026-03-18WarningsExact identifier
unii: 451W47IQ8X
UniversaltoxALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, HORDEUM VULGARE, NASTURTIUM AQUATICUM, RAPHANUS SATIVUS, TRITICUM AESTIVUM, IODIUM, UBIDECARENONUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, MANGANESE GLUCONATE, ORYZA SATIVA, THYROIDINUM (SUIS), CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RHUS TOX, CORTISONE ACETICUMBioActive Nutritional, Inc.ad454e8a-4f78-4aac-90d9-a3f26a6fbe422026-03-17WarningsExact identifier
unii: 451W47IQ8X
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Sterillium comfortALCOHOLBODE Chemie GmbH2d48dab8-f70a-a2b5-e063-6294a90a14562026-03-16WarningsExact identifier
unii: 3K9958V90M
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMKC Pharmaceuticals, Inc.4d1d9b3a-ac5f-db27-e063-6294a90afc3f2026-03-16WarningsExact identifier
unii: K679OBS311
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRedicare LLC4d1e5089-22b0-7b3f-e063-6294a90a346a2026-03-16WarningsExact identifier
unii: K679OBS311
BM BIO27CALC PHOS, KALI PHOS, NAT MURBM Private Limited4d229815-05f4-27c5-e063-6394a90ac8652026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO1CALC PHOS, FERR PHOS, KALI PHOS, NAT MURBM Private Limited4d265d99-fdbb-5efb-e063-6394a90a89ac2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d26b4a9-ee27-6915-e063-6294a90a5d4d2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO12FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d2747ad-958e-63a1-e063-6294a90aea662026-03-16WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.