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 26 of 134 · 2,667 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Blue Lizard Sensitive Face SunscreenTITANIUM DIOXIDE, ZINC OXIDECrown Laboratories88dbd396-8955-271e-e053-2995a90a0a7a2026-01-12WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Baby SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories9d237fb7-4f5f-521d-e053-2a95a90a97342026-01-12WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Sensitive SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories1e4d49f4-9e77-48b5-bce5-ff04ed885a0f2026-01-12WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Baby SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories32d6e04a-fa30-ba48-e063-6394a90a1bbf2026-01-12WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Kids SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories2f780daa-4c91-5a68-e063-6394a90afd412026-01-12WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Sport SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories2f3844d8-0367-aad9-e063-6294a90a1fce2026-01-12WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Sheer Face SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories30cd79da-2f25-a42a-e063-6394a90a83322026-01-12WarningsExact identifier
unii: 15FIX9V2JP
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
Menopause ReliefBARIUM CARBONATE, ATROPA BELLADONNA, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SILICON DIOXIDEHomeocare Laboratories99b182d5-4102-4b25-85d3-f4be077d753f2026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
ACCOJE PROTECTIVE AIR-FIT MINERAL SUNSCREENTITAMIUN DIOXIDE, ZINC OXIDEUCL Co., Ltd.4837b4f6-ada9-801a-e063-6294a90a85472026-01-12WarningsExact identifier
unii: 15FIX9V2JP
Amber AmethystAMBER AMETHYSTUriel Pharmacy, Inc4837e805-a777-c1fa-e063-6294a90ae9c42026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
Intellishade Original SPF 45OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe213a681-eb22-69c0-e053-2995a90a899e2026-01-12WarningsExact identifier
unii: 15FIX9V2JP
ECHINACEAECHINACEA ANGUSTIFOLIA, HAMAMMELIS VIRGINIANA, CALCAREA PHOSPHORICA, HYDRASTIS CANADANESIS, SENEGA OFFICINALIS, SILICEA, CONIUM, AURUM MURIATICUM NATRONATUM, CALCAREA CARBONICA, FUCUS VESICULOSUS, LACHESIS MUTUSMarco Pharma International LLC.7efadb70-99e4-428b-a8ef-a2797327c6fa2026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
ODLUMIVIE Tinted Mineral SunscreenZINC OXIDE,TITANIUM DIOXIDEGuangzhou Meijiao Medical Biotechnology Co., Ltd.480d6e65-f6dc-d2a5-e063-6294a90a24a12026-01-10WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen Lotion118mLZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46355437-4068-9d03-e063-6394a90ae52c2026-01-09WarningsExact identifier
unii: 15FIX9V2JP
ST MORIZ SUNCARE FACE SUNSCREEN SPF30SUNCARE FACE SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.47f26af6-4d02-3506-e063-6294a90a0fe62026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Play Mineral Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC89088ac5-f1ee-1996-e053-2a95a90a8fdc2026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Sugargirl Set Screen SPF 30 Setting Powder Sunscreen LightZINC OXIDE, TITANIUM DIOXIDEI World LLC1fabd546-55e5-4ab2-8a1b-7b161bfbb8662026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Sugargirl Set Screen SPF 30 Setting Sunscreen MediumZINC OXIDE, TITANIUM DIOXIDEI World LLC876a6f88-8dac-4303-8acb-525999c935282026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Sugargirl Set Screen SPF 30 Setting Sunscreen TranslucentZINC OXIDE, TITANIUM DIOXIDEI World LLC0a3bae73-141b-4a47-be35-c5708dfb11802026-01-09WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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