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 16 of 134 · 2,667 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sei Bella Tinted BB Moisturizing Cream410 NMelaleuca Inc.2f380433-3369-9d05-e063-6394a90a64792026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream115 NMelaleuca Inc.2f132cc0-e8e3-35e3-e063-6394a90a4f3d2026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Tinted Sunscreen Broad SPF30TINTED SUNSCREEN BROAD SPF30DOSCHER FAMILY HEALTH NP P.C.4d4021ba-4b29-6b81-e063-6294a90a5ea72026-03-17WarningsExact identifier
unii: 15FIX9V2JP
BM BIO18CALC FLUOR, CALC SULF, SILICEA.BM Private Limited4d269a3b-18ba-3ad2-e063-6294a90a1fae2026-03-16WarningsExact identifier
unii: ETJ7Z6XBU4
HYDRATING TINTED MOISTURIZER SPF50HYDRATING TINTED MOISTURIZER SPF50NING PTE. LTD.4cf8d3d3-eebf-2da0-e063-6294a90a70652026-03-14WarningsExact identifier
unii: 15FIX9V2JP
TINTED WATERY SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEKSISTERS PTE. LTD.4ced53d0-8bfc-ff8e-e063-6294a90a9dbd2026-03-13WarningsExact identifier
unii: 15FIX9V2JP
Daily Moisturizing Mineral SunscreenBROAD SPECTRUM SPF30EDINA PLASTIC SURGERY,LTD.4d056e2b-5813-da42-e063-6294a90ac5192026-03-13WarningsExact identifier
unii: 15FIX9V2JP
LigatoneARNICA MONTANA, BRYONIA, CALCAREA PHOSPHORICA, CAUSTICUM, KALI CARBONICUM, MANGANESE GLUCONATE, MEZEREUM, RHUS TOX, RUTA GRAVEOLENS, SILICEABioActive Nutritional, Inc.3a3bdd55-daec-43b9-a380-54a747fb7d102026-03-13WarningsExact identifier
unii: ETJ7Z6XBU4
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440CTITANIUM DIOXIDEKenvue Brands LLC4c335d9c-40ca-c0ce-e063-6394a90ac20a2026-03-11WarningsExact identifier
unii: 15FIX9V2JP
Lower GI and Probiotic RestorationAETHUSA CYNAPIUM, ALLIUM SATIVUM, BAPTISIA TINCTORIA, CAPSICUM ANNUUM, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, CONDURANGO, GAMBOGIA, GRATIOLA OFFICINALIS, LAC VACCINUM, LACTICUM ACIDUM, NATRUM CARBONICUM, NUX VOMICA, PODOPHYLLUM PELTATUM, SEPIA AND SILICEA.King Bio Inc.2e1f3ca1-9036-4f14-bd3c-d0eed9a9ff932026-03-10WarningsExact identifier
unii: ETJ7Z6XBU4
Constitutional EnhancerACONITUM NAPELLUS, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA, CALCAREA CARBONICA, CANTHARIS, GELSEMIUM SEMPERVIRENS, GRAPHITES, HYDRASTIS CANADENSIS, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOX, SEPIA, SILICEA AND SULPHUR.King Bio Inc.448becd7-58aa-40ae-9b4b-39f48a8f13dd2026-03-10WarningsExact identifier
unii: ETJ7Z6XBU4
VermiclearGRANATUM, RHAMNUS PURSHIANA, JUGLANS REGIA, FILIX MAS, ABSINTHIUM, AESCULUS HIPPOCASTANUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CINA, CINCHONA OFFICINALIS, CUPRUM METALLICUM, IPECACUANHA, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NUX VOMICA, PODOPHYLLUM PELTATUM, PULSATILLA (VULGARIS), RATANHIA, RHUS TOX, SABADILLA, SILICEA, SPIGELIA ANTHELMIA, TEREBINTHINA, TEUCRIUM MARUMEnergique, Inc.f7cf3edd-2451-4a4f-b1f2-1b3db2bb4dca2026-03-09WarningsExact identifier
unii: ETJ7Z6XBU4
NamzaricMEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEAllergan, Inc.90fedc32-19e5-480c-afc6-f35a5cf4b9aa2026-03-06Warnings, Adverse reactionsExact identifier
unii: JY0WD0UA60
MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDEDirectRxd0839a2d-35f1-1f14-e053-2995a90ad5492026-03-06Warnings, Adverse reactionsExact identifier
unii: JY0WD0UA60
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION4490f968-46b6-44d2-af2d-5130b52c88612026-03-05WarningsExact identifier
unii: 15FIX9V2JP
OsteoplexEQUISETUM HYEMALE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, MANGANUM MURIATICUM, SYMPHYTUM OFFICINALE, MEDULLA OSSIS SUIS, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA, PARATHYROID GLAND (SUIS), LIGAMENT (SUIS)BioActive Nutritional, Inc.8a7e1397-a387-4f2c-ab4f-7f1a7f1a849b2026-03-05WarningsExact identifier
unii: ETJ7Z6XBU4
Respiforce A-HPARSENICUM ALBUM, BELLADONNA, IPECACUANHA, KALI CARBONICUM, LOBELIA INFLATA, NATRUM SULPHURICUM, SILICEABioActive Nutritional, Inc.ebf5f0c7-e7a4-45fe-acfd-52c46a8d789c2026-03-05WarningsExact identifier
unii: ETJ7Z6XBU4
Sinus Defense 2.0LAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODEMicro Balance Health Products LLC560f84f6-2544-4ba8-8236-a95906eb7d972026-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
Snore ControlBROMIUM, CHAMOMILLA, CINCHONA, CUPRUM METALLICUM, HELLEBORUS NIGER, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LAUROCERASUS, NUX VOMICA, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, STRAMONIUM, SULPHUR AND ZINCUM METALLICUM.King Bio Inc.704bb574-6c54-49d1-bdae-81ffe0e79d102026-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
Memantine HydrochlorideMEMANTINE HYDROCHLORIDE ORALSeton Pharmaceuticals421f6478-09df-49d3-a7c4-52814b4aa90e2026-02-27Warnings, Adverse reactionsExact identifier
unii: JY0WD0UA60

Reported adverse events (FAERS/openFDA)#

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