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
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Effective date
2024-05-30
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 Pharma2024-05-30HUMAN 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 17 of 221 · 4,411 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NatureWell Hydrating Hand Sanitizer, Paradise PleaseALCOHOLAmerican Exchange Group6d75c795-ff84-4775-8f7d-a2416acf845e2026-07-10WarningsExact identifier
unii: 3K9958V90M
NatureWell Hydrating Hand Sanitizer, Hinoki HourALCOHOLAmerican Exchange Group303866ab-8b9f-4e74-8408-62e57bb731d72026-07-10WarningsExact identifier
unii: 3K9958V90M
NatureWell Hydrating Hand Sanitizer, Pineapple PopALCOHOLAmerican Exchange Group20aa290f-39e4-4bc9-9128-d6268d8d74d02026-07-10WarningsExact identifier
unii: 3K9958V90M
NatureWell Hydrating Hand Sanitizer Vanilla DaydreamALCOHOLAmerican Exchange Groupa188f0ef-75fa-4ace-8712-7ce592ae19572026-07-10WarningsExact identifier
unii: 3K9958V90M
NatureWell Hydrating Hand Sanitizer Clean GirlALCOHOLAmerican Exchange Groupf5588dff-3299-47c5-a570-94c346b6b2e92026-07-10WarningsExact identifier
unii: 3K9958V90M
Smart Care CHAMPAGNE TOAST 2 HAND SANITIZERS 1.35 FL OZETHYL ALCOHOLAshtel Studios, Inc.1bd51131-b3df-4cf9-959b-45724484ffc62026-07-10WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Biobased ContentALCOHOLGOJO Industries, LLC60584888-a800-4825-85b3-cf55ca7c045e2026-07-09WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical MangoETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC56148c12-7d6f-26bf-e063-6294a90a93df2026-07-08WarningsExact identifier
unii: 3K9958V90M
ATTITUDE Little Leaves Hand Sanitizer Watermelon and CoconutETHYL ALCOHOL9055-7588 Quebec Inc. DBA Attitude09d21713-f279-489c-e063-6394a90a67792026-07-08WarningsExact identifier
unii: 3K9958V90M
hand sanitizerHAND SANITIZERShenzhen yuehaotong Technology Co., Ltd561af7a3-25a5-1384-e063-6394a90abb592026-07-08WarningsExact identifier
unii: 3K9958V90M
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX
Beautifier Life ALCOHOL WIPESBEAUTIFIER LIFE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD323ef469-e37c-00ad-e063-6394a90ab6f72026-07-08WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical MangoETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.5600cf8a-5aba-1a22-e063-6394a90a80832026-07-07WarningsExact identifier
unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pink SugarETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5600dc30-192d-19b1-e063-6394a90a66d32026-07-07WarningsExact identifier
unii: 3K9958V90M
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
ATTITUDE Super Leaves Hand Sanitizer Lemon LeavesETHYL ALCOHOL9055-7588 Quebec Inc. DBA Attitude09d3c8c0-74d5-f49d-e063-6394a90a48152026-07-07WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST WATERMELON POP SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedb487f98e-63b1-40d9-bc8b-524b4be3f86c2026-07-06WarningsExact identifier
unii: 3K9958V90M
Beach In A Bottle Hand SanitizerETHYL ALCOHOLPEACH LAYNE, LLC556fa4b6-c1af-bc36-e063-6394a90a7f312026-07-06WarningsExact identifier
unii: 3K9958V90M
Sugarcoat Hand SanitizerETHYL ALCOHOLPEACH LAYNE, LLC5570284d-0872-1fee-e063-6294a90a9b652026-07-06WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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