FDA.reportPublic FDA data

NDC 0591-3875-45 - memantine hydrochloride

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
0591-3875
Requested NDC
0591-3875-45
Package NDCs from labels
0591-3875-60, 0591-3875-45, 0591-3875-44
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-06-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
memantine hydrochloride - Cardinal Health 107, LLCCardinal Health 107, LLC2026-06-05HUMAN PRESCRIPTION DRUG LABEL
memantine hydrochloride - Actavis Pharma, Inc.Actavis Pharma, Inc.2018-11-01HUMAN PRESCRIPTION DRUG LABEL
memantine hydrochloride - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2017-11-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-3875-44memantine hydrochloride10 in 1 BOX, UNIT-DOSETABLET1010
0591-3875-45memantine hydrochloride10 in 1 BLISTER PACKTABLET1010
0591-3875-60memantine hydrochloride60 in 1 BOTTLETABLET6010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3875MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC.]10Current NDC, Legacy NDC, 3 package rows20240509_72973b46-f307-4a9e-8fb1-ad2cbccfd736.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3875-44EA - Each0591-387570d3ea14-a284-436b-9c5d-5d3d95c2a7fb12015-08-04
0591-3875-45EA - Each0591-3875be7f5f5f-a881-43c6-b037-e0bfb381802212015-08-04
0591-3875-60EA - Each0591-387535bfa198-d358-451e-9818-78ceadb81c0a12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
memantineACTIVE MOIETYW8O17SJF3TMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
FD&C blue No. 2INACTIVE INGREDIENTL06K8R7DQKMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
sorbitolINACTIVE INGREDIENT506T60A25RMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
talcINACTIVE INGREDIENT7SEV7J4R1UMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC]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 36 of 141 · 2,816 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Discount Drug Mart Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEDiscount Drug Mart, Inc.f75c2f84-a28c-5807-e053-6294a90a22952025-12-30WarningsExact identifier
unii: B697894SGQ
Discount Drug Mart Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Discount Drug Martf7fd53be-e501-d97f-e053-6394a90ad4092025-12-30WarningsExact identifier
unii: B697894SGQ
unii: 3NXW29V3WO
Exchange Select Eye Drops Advanced Relief MoisturizerDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLArmy and Air Force Exchange Service9e475240-2df1-9bee-e053-2995a90a8d4b2025-12-30WarningsExact identifier
unii: B697894SGQ
Exchange Select Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Army and Air Force Exchange Service9e478343-8ae7-823e-e053-2995a90a84ed2025-12-30WarningsExact identifier
unii: B697894SGQ
unii: 3NXW29V3WO
Family Wellness Advanced Redness Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLFamily Dollar Services, Inc.fabec215-a040-3f4e-e053-6394a90ad45f2025-12-30WarningsExact identifier
unii: B697894SGQ
DG Health Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLDolgencorp LLC9c62f8a3-7cf5-40f9-e053-2a95a90afd862025-12-30WarningsExact identifier
unii: B697894SGQ
Medics Choice Eye Drops AdvancedTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONEKC Pharmaceuticals, Inc.ab906fd8-265c-4359-a920-d626366e245c2025-12-30WarningsExact identifier
unii: B697894SGQ
Medics Choice Fresh and Soothe Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLKC Pharmaceuticals, Inc.1f65b91a-4eac-65c2-e063-6394a90a02952025-12-30WarningsExact identifier
unii: B697894SGQ
DG Health Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400Dolgencorp LLC9cb20c3b-bf6d-8c7c-e053-2995a90aa4852025-12-30WarningsExact identifier
unii: B697894SGQ
unii: 3NXW29V3WO
DG Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLDolgencorp LLC9cb27899-6c36-3c37-e053-2995a90a1d432025-12-30WarningsExact identifier
unii: B697894SGQ
Publix Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEPublix Super Markets, Inc.f7b0c3d6-0324-46c3-e053-6394a90a82412025-12-30WarningsExact identifier
unii: B697894SGQ
Publix High Performance Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLPublix Super Markets, Inc.9b402aa8-87cb-3928-e053-2995a90afa3c2025-12-30WarningsExact identifier
unii: B697894SGQ
Health Mart Lubricating TearsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLCc8be678f-2b4a-4d39-9cb4-910d36d721742025-12-30WarningsExact identifier
unii: B697894SGQ
Core Values Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Liberty Procurement Co. Inc.f8285f68-c40c-19a8-e053-6394a90aacad2025-12-30WarningsExact identifier
unii: B697894SGQ
unii: 3NXW29V3WO
Core Values Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDELiberty Procurement Co., Inc.f76dfeca-4e86-0b5d-e053-6294a90a29b92025-12-30WarningsExact identifier
unii: B697894SGQ
Harris Teeter Eye Drops Artificial TearsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Harris Teeter, LLC.f82957d9-c4ad-a914-e053-6294a90aac502025-12-30WarningsExact identifier
unii: B697894SGQ
unii: 3NXW29V3WO
Best Choice Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEValu Merchandisers, Co.f7491a17-8035-5a3c-e053-6294a90a615c2025-12-30WarningsExact identifier
unii: B697894SGQ
Winco Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLWinCo Foods, LLCf10778c8-14fe-4852-8b73-42db502fd2bc2025-12-30WarningsExact identifier
unii: B697894SGQ
Harris Teeter Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHarris Teeter, LLCf76e2831-5c6c-7a62-e053-6294a90a937b2025-12-30WarningsExact identifier
unii: B697894SGQ
CVS Gentle TearsDEXTRAN 70, HYPROMELLOSECVS Pharmacy, Inc.9b1ea0eb-c34f-6603-e053-2995a90a6a952025-12-30WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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