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 22 of 141 · 2,816 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1d6f10b7-60b9-47f6-9dba-1dd0a7cf6f5d2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1aae19da-1e73-41ed-91dc-0746ad311b872026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior22d4452d-3798-48c6-a7a4-4af0f99b4ebd2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diord6800bb7-16ef-48f6-a09a-0422e64ad8bd2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorfb9cfd4f-a558-4df2-bbbf-b814ae19a1352026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb9ddcda6-3d87-4197-a2c2-5b30016d32eb2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior25abef37-1726-491f-8a11-ac1a96378ed12026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 8N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb0e315b3-a322-4607-b212-bcadd5aa99bc2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 9N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorcc0f19fc-7b6f-4454-9a77-dc11f0fd12512026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 10N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc361a514-5fc9-42a7-b1fc-28e4a11ad7332026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 00 NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diordb38ced5-dfbe-4b7e-b4ae-3065df1898b02026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 00,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4ead1ce8-f31d-4676-8619-8d49dd62db2e2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior827caf09-222e-487a-941c-44eb5c13d5d62026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf3c378e1-853b-463e-9fc3-6a54ef8610442026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc3a479c4-807e-4c52-a27f-eea8705b9c1e2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorcb63faaa-82d8-469a-a9a1-88b09e02cc352026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc20b0b8b-366a-47ff-84b6-264fa8ed6de02026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior31d89246-418d-4ed4-8e32-7aa2422073a92026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior31b74e11-c5e5-4086-baa5-e7a39dc556a02026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior29ec217b-7726-4590-8a0d-e4b08217e2222026-01-16WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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