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 51 of 139 · 2,768 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Lip Shade SunscreenTITANIUM DIOXIDE, ZINC OXIDEBLISS BEAUTY LLC373a7c01-ba9f-4b00-e063-6294a90ae1a22025-12-15Exact identifier
unii: 15FIX9V2JP
Daily Shade Matte TintedTITANIUM DIOXIDE, ZINC OXIDEBLISS BEAUTY LLC373b7ab9-c692-fc1b-e063-6294a90aa8032025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBASS & KLASS, INC36af24e2-015a-a9a7-e063-6294a90a2fce2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEBASS & KLASS, INC36add3a3-f1ff-3986-e063-6394a90ab7fe2025-12-15Exact identifier
unii: 15FIX9V2JP
Mucus and Sinus Mucus and Sinus Symptom ReliefBRYONIA ALBA, HYDRASTIS CANADENSIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA PRATENSIS, SILICEA, STANNUM METALLICUM, THUJA OCCIDENTALIS, ZINCUM GLUCONICUMTRP Company2a42c4a3-9486-9b29-e063-6294a90a7c702025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Natural Relief Cold and Flu Plus ZincALLIUM CEPA, ARSENICUM ALBUM, BRYONIA ALBA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, NATRUM MURIATICUM, NUX VOMICA, SILICEA, SULPHUR, ZINCUM GLUCONICUMTRP Company2a352cf2-48fb-4862-e063-6294a90a2eeb2025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Ring ReliefARNICA MONTANA - CALCIUM SULFIDE - HYPERICUM PERFORATUM - LYCOPODIUM CLAVATUM SPORE - MERCURIUS SOLUBILIS - SALICYLIC ACID - SILICON DIOXIDE - ALLYLTHIOUREA -TRP Companyaa2cd967-3c27-4afe-8751-7ea50ab629132025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Ring ReliefARNICA MONTANA, CALCIUM SULFIDE, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM SPORE, THIOSINAMINUM, MERCURIUS SOLUBILIS, SALICYLIC ACID, SILICON DIOXIDE, ALLYLTHIOUREATRP Company1c9c7944-31a9-4019-aad5-6b7f86084b532025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Ring Relief PM Nighttime FormulaARNICA MONTANA, CALCIUM SULFIDE, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM SPORE, THIOSINAMINUM, MERCURIUS SOLUBILIS, SALICYLIC ACID, SILICON DIOXIDE, ALLYLTHIOUREATRP Company92ef0dd1-84f9-086c-e053-2a95a90ac6472025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Swimmers Ear Complete ReliefCALCIUM SULFIDE, LOESELIA MEXICANA TOP, MERCURIUS SOLUBILIS, POTASSIUM CHLORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, VALERIANTRP Companya3425da3-ace9-05c2-e053-2995a90ab09f2025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
COOLA BARE REPUBLIC MINERAL SPORT SPF50TITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCbbf15e58-c160-d599-e053-2a95a90a06962025-12-14WarningsExact identifier
unii: 15FIX9V2JP
Lip ProtectingTITANIUM DIOXIDE, ZINC OXIDEJOHANNA'S SKIN CARE3544b8f2-2651-4c01-e063-6394a90ae53d2025-12-12Exact identifier
unii: 15FIX9V2JP
Tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEJOHANNA'S SKIN CARE3544faa1-ebdf-5dbd-e063-6394a90a76312025-12-12Exact identifier
unii: 15FIX9V2JP
Tinted Facial Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3531d609-a0d8-cb59-e063-6394a90a4bea2025-12-12Exact identifier
unii: 15FIX9V2JP
Tinted Facial Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3532a6a2-dbb5-8111-e063-6294a90aeaeb2025-12-12Exact identifier
unii: 15FIX9V2JP
Tinted Daily Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERSL89 LLC35338026-525a-d8b3-e063-6394a90a98f52025-12-12Exact identifier
unii: 15FIX9V2JP
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDERSL89 LLC3541971e-3664-a9f5-e063-6294a90ac2d22025-12-12Exact identifier
unii: 15FIX9V2JP
Prime Protection Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS36608832-22d8-bc76-e063-6394a90abac62025-12-12Exact identifier
unii: 15FIX9V2JP
Prime Protection Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS3660af9e-d60f-c33e-e063-6394a90a3a052025-12-12Exact identifier
unii: 15FIX9V2JP
Prime Protection Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS3660e701-1373-eef4-e063-6394a90a61402025-12-12Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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