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 11 of 134 · 2,667 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509cad98-0321-2a0a-e063-6294a90a6ea92026-04-29WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509d7206-0cc1-c997-e063-6294a90a89e02026-04-29WarningsExact identifier
unii: 15FIX9V2JP
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEGPNY CORP211dea04-faad-8ffc-e063-6294a90a8d682026-04-29WarningsExact identifier
unii: 15FIX9V2JP
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
unii: 15FIX9V2JP
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Memantine HydrochlorideMEMANTINE HYDROCHLORIDESlate Run Pharmaceuticals, LLCa74050c4-5a37-4fa1-85d9-85831525cfeb2026-04-21Warnings, Adverse reactionsExact identifier
unii: JY0WD0UA60
ELROEL Pang Pang Sun Cushion S7ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.256bf56f-aefa-47ce-890c-5a3896c11b922026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion FairTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.3a43c7c0-7468-4b7a-95b9-f03e37f1b49b2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.a251eb20-02e6-4b55-b969-c1bef2f9d7322026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair PinkTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.6684d69a-89ff-41e8-81f0-3e2367811a182026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.bf24d081-85f7-4a26-9416-ecff1fe59dec2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Pink LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.4a09a01a-404f-4b67-91e0-666153f550e82026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion N-LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.cf7c4445-0382-47ab-aba9-b40d63e4f1cc2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.80c60ffa-69e0-4b31-bd0d-fc8ff9936ba02026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.0e18d601-700a-4c1c-a434-22582253bd952026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion BronzeTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.ddb3aa5e-cd1a-4792-b1b1-3604b368e0102026-04-17WarningsExact identifier
unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-DEEPYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e246e64-2eab-1219-e063-6294a90a79a82026-04-17WarningsExact identifier
unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-FAIR GLOWYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cd8a3-3d62-83ac-e063-6394a90a4afa2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- HONEY GLOWYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e2424f4-0011-42b0-e063-6394a90a780d2026-04-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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