FDA.reportPublic FDA data

NDC 42292-005-01 - 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
42292-005
Requested NDC
42292-005-01
Package NDCs from labels
42292-005-01, 42292-005-06
Manufacturer
Mylan Institutional Inc.
Effective date
2018-12-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Memantine Hydrochloride - Mylan Institutional Inc.Mylan Institutional Inc.2018-12-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42292-005-01EA - Each42292-005fd057fe1-2d94-4bd2-ae4f-775b9d4901c212015-09-10
42292-005-06EA - Each42292-00530039fd2-5c74-4895-80eb-85af1793781c12015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2
MEMANTINEACTIVE MOIETYW8O17SJF3TMEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UMEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET [MYLAN INSTITUTIONAL INC.]2

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 124 of 134 · 2,665 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack8bd5b908-f46a-4ced-9408-45984d7161492023-03-24Warnings, Adverse reactionsExact identifier
unii: JY0WD0UA60
NS SupportBERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS SUIS, PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUM,Dr. Donna Restivo DC807fd9cf-13d1-4173-a6da-180f89b67cf22023-03-15WarningsExact identifier
unii: ETJ7Z6XBU4
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe02023-03-03Warnings, Adverse reactionsExact identifier
unii: JY0WD0UA60
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack54a12ddf-306b-4eb7-a7c3-c7b58df3b3722023-03-03Warnings, Adverse reactionsExact identifier
unii: JY0WD0UA60
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackfac8c59b-5bf5-478e-8223-a5ecaa4006252023-03-03Warnings, Adverse reactionsExact identifier
unii: JY0WD0UA60
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackc8f96b24-de66-4a17-b798-42b42a25e84c2023-03-03Warnings, Adverse reactionsExact identifier
unii: JY0WD0UA60
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUSDeseret Biologicals, Inc.d29af0e7-0d04-47e3-9a50-d99c7e14b44d2023-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d395ec-3c3b-5e5f-e053-2a91aa0a3f9c2023-02-20Exact identifier
unii: ETJ7Z6XBU4
EyeClear ProCALC CARB, CALC FLUOR, CAUSTICUM, CINERARIA, EUPHRASIA, NAPHTHALINUM, NAT MUR, PHOS, QUASSIA, SILICEASilver Star Brandsf4d4943b-cb78-aa71-e053-2a95a90ac6382023-02-16WarningsExact identifier
unii: ETJ7Z6XBU4
CellTropinARGININE, GINKGO BILOBA, HYPOPHYSIS SUIS, SILICEA, ASTRAGALUS EXCAPUSMicro Balance Health Products LLC502d3ffa-bbf4-403a-9fad-b6b229f36a8c2023-02-14WarningsExact identifier
unii: ETJ7Z6XBU4
Mineral Sunscreen SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.3a637542-0f79-47ae-815d-84d0036c737a2023-02-13WarningsExact identifier
unii: 15FIX9V2JP
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEMacleods Pharmaceuticals Limited42f0a9f2-4aa4-46fb-bc24-d3df843bb9062023-02-09Warnings, Adverse reactionsExact identifier
unii: JY0WD0UA60
memantineMEMANTINEChartwell RX, LLC6906b0b4-1944-40f0-844a-e0db72ba46752023-02-02Warnings, Adverse reactionsExact identifier
unii: JY0WD0UA60
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAlembic Pharmaceuticals Limitedb86c0f6e-480b-40e7-aa4d-21bd0659101d2023-01-30Warnings, Adverse reactionsExact identifier
unii: JY0WD0UA60
SiliceaSILICON DIOXIDEBoiron86d2db09-9c46-37f7-e053-2a91aa0a326f2023-01-23Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3be33-b50e-e649-e053-2a91aa0acfc52023-01-23Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3be33-b4fb-e649-e053-2a91aa0acfc52023-01-23Exact identifier
unii: ETJ7Z6XBU4
Josie Maran Argan Daily Moisturizer SPF47ZINC OXIDE, TITANIUM DIOXIDEAutumn Harp, Inc.027821e6-db7d-4c03-956a-00313488ebc72023-01-14Boxed warning, WarningsExact identifier
unii: 15FIX9V2JP
Gyno ComplexVIBURNUM OPULUS, MAGNESIA PHOSPHORICA, FOLLICULINUM, PULSATILLA (PRATENSIS), BORAX, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, SILICEA, THUJA OCCIDENTALISDeseret Biologicals, Incdfaaa56a-4226-4f62-a219-d3f89fe7afe32023-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d367e5-e846-54ba-e053-2991aa0a63d42023-01-12Exact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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