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 49 of 218 · 4,341 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Optimel Manuka Dry Eye DropsGLYCERINMelcare Biomedical Pty Ltd88c5e2f0-9f7e-62d1-e053-2995a90a90142026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Optimel Manuka Forte Eye GelGLYCERINMelcare Biomedical Pty Ltd8e0ed6e8-51fc-7c5b-e053-2a95a90a35a92026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Hand Sanitizing WipesETHYL ALCOHOLUpLift Brands, LLCca7c6243-dc7f-40c4-8b51-ec9a7c1f14f52026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLUpLift Brands, LLCba4be8c2-00ce-48e6-a83c-6c1bde3c3aa42026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLUpLift Brands LLCf6608379-051f-4151-bcf7-ecd87070f4392026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Moisturizing Hand SanitizerETHYL ALCOHOLUpLift Brands, LLCa1954926-35f6-439e-863f-29351013e5542026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLUpLift Brands LLCdd569334-0280-49d6-afcf-0c49ed316cb92026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLUpLift Brands, LLCef02b350-1a37-42d4-8eaa-38a2de5e41eb2026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Moisturizing Hand SanitizerETHYL ALCOHOLUpLift Brands, LLCbf53255d-18d7-4672-8139-bacc5cb1a2e62026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLUpLift Brands, LLC03ed8a06-33aa-4893-824c-a3843962de3d2026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand Sanitizer with AloeETHYL ALCOHOLUpLift Brands, LLC62cfbf46-9c12-487f-81d9-a1f839402ec42026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
ETHYL ALCOHOLETHYL ALCOHOLUpLift Brands, LLC42b1aff5-d788-0d46-e063-6294a90a02d32026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Whipped Vanilla CloudsALCOHOLBath & Body Works, Inc.46178c56-3e33-4523-e063-6394a90aca792026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Blue Raspberry FreezeALCOHOLBath & Body Works, Inc.4616db35-113d-970f-e063-6394a90aa38d2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pistachio Milk and HoneyALCOHOLBath & Body Works, Inc.4616f2ce-1b5e-436d-e063-6394a90acbe22026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sparkling WatermelonALCOHOLBath & Body Works, Inc.46156243-39d7-f56c-e063-6394a90a2d2c2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Raspberries and Whipped VanillaALCOHOLBath & Body Works, Inc.46179a73-7a7b-7e3b-e063-6294a90a06d62026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Mini Cookie BitesALCOHOLBath & Body Works, Inc.46171e50-519f-c877-e063-6294a90acc762026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Gummi SnacksALCOHOLBath & Body Works, Inc.46174492-efb9-cf84-e063-6294a90a0c462026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel White PumpkinALCOHOLBath & Body Works, Inc.4617c406-26da-867b-e063-6394a90ae2a22026-03-10WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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