FDA.reportPublic FDA data

NDC 64679-121-07 - 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
64679-121
Requested NDC
64679-121-07
Package NDCs from labels
64679-121-01, 64679-121-02, 64679-121-07, 64679-121-06, 64679-121-08, 64679-121-03
Manufacturer
Wockhardt USA LLC. | Wockhardt Limited | Vivimed Life Sciences Private Limited
Effective date
2017-12-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Memantine Hydrochloride - Wockhardt USA LLC. | Wockhardt Limited | Vivimed Life Sciences Private LimitedWockhardt USA LLC. | Wockhardt Limited | Vivimed Life Sciences Private Limited2017-12-19HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
64679-121-012024-12-11These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
64679-121-022024-12-11These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
64679-121-032024-12-11These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
64679-121-062024-12-11These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
64679-121-082024-12-11These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
64679-121-012020-01-31These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
64679-121-022020-01-31These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
64679-121-032020-01-31These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
64679-121-062020-01-31These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
64679-121-082020-01-31These highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for memantine hydrochloride. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-121-02EA - Each64679-12168c7d63f-0966-476f-9228-c4a3844438e112015-12-02
64679-121-03EA - Each64679-121f03c9a8a-629e-4155-adb1-a4966ac25cb012015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]1
MEMANTINEACTIVE MOIETYW8O17SJF3TMEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673MEMANTINE HYDROCHLORIDE ( MEMANTINE HYDROCHLORIDE ) KIT MEMANTINE HYDROCHLORIDE TABLET [WOCKHARDT USA LLC.]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 41 of 133 · 2,652 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral Sunscreen Broad Spectrum SPF 40TITANIUM DIOXIDE, ZINC OXIDEWECARE FRISCO PLLC374f866d-eb52-61e3-e063-6394a90a77c72025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDEWECARE FRISCO PLLC3750c23d-c3f8-fac3-e063-6394a90a135e2025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEKATHY JONES AESTHETHICS LLC37dab729-5988-5eba-e063-6294a90ac6b72025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETory Sullivan, M.D., P.A.36241e60-f02a-50a7-e063-6394a90a63902025-12-16Exact identifier
unii: 15FIX9V2JP
UV Defense Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC365e09a8-308b-b753-e063-6394a90ae9e52025-12-16Exact identifier
unii: 15FIX9V2JP
UV Defense Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDECCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC365e2498-7df2-f22c-e063-6294a90ac6ab2025-12-16Exact identifier
unii: 15FIX9V2JP
UV Protection Veil Mineral Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3bf5a6-33ec-0255-e063-6294a90ac96a2025-12-16WarningsExact identifier
unii: 15FIX9V2JP
UV Protection Veil Mineral Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3cba2e-acc6-a2df-e063-6294a90abf712025-12-16WarningsExact identifier
unii: 15FIX9V2JP
UV Protection Veil Mineral Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEATHENA PLASTIC SURGERY3b3c757f-6581-4978-e063-6294a90a61732025-12-16WarningsExact identifier
unii: 15FIX9V2JP
Virgo SOL Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEULTRAVIOLET SKINCARE LLC369d4f43-8c57-9fcf-e063-6294a90aa9162025-12-16Exact identifier
unii: 15FIX9V2JP
Virgo SOL Non Tinted MousseTITANIUM DIOXIDE, ZINC OXIDEULTRAVIOLET SKINCARE LLC369d63a9-b9ab-9530-e063-6394a90ac8ef2025-12-16Exact identifier
unii: 15FIX9V2JP
Kind Restore Moisturizing Lip BalmTITANIUM DIOXIDE, ZINC OXIDEPOLISH BEAUTY39814e27-4f3f-5ee6-e063-6394a90a941b2025-12-16Exact identifier
unii: 15FIX9V2JP
Dr B Clinical Skin Care Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDENAIRA BABAIAN, M.D., P.A.365da1f8-5250-7589-e063-6294a90a3e682025-12-16Exact identifier
unii: 15FIX9V2JP
Dr B Clinical Skin Care Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDENAIRA BABAIAN, M.D., P.A.365d7564-3025-257b-e063-6294a90ad1702025-12-16Exact identifier
unii: 15FIX9V2JP
Matte Defense Mineral Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEPURE VITALITY SKIN AND BODY, INC3698090a-1639-00f9-e063-6394a90a7dd12025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Primer SPF 40TITANIUM DIOXIDE, ZINC OXIDEJOSEPHINA RAMIREZ365cf2be-8862-3622-e063-6394a90ac4e32025-12-16Exact identifier
unii: 15FIX9V2JP
SANCTUARY Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECHAMPAGNE APOTHECARY LLC365ca99c-c878-1f4b-e063-6394a90a1f532025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILL VALLEY DERMATOLOGY, INC.3b171a89-c757-47a1-e063-6294a90a7a642025-12-16WarningsExact identifier
unii: 15FIX9V2JP
Silk Screen TintedTITANIUM DIOXIDE, ZINC OXIDESkin Science Institute Inc36c3793a-ccb5-1e5f-e063-6294a90ad44f2025-12-16Exact identifier
unii: 15FIX9V2JP
Silk Screen TintedTITANIUM DIOXIDE, ZINC OXIDESkin Science Institute Inc36c3a721-6be1-3f7f-e063-6394a90a522f2025-12-16Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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