FDA.reportPublic FDA data

Namenda

Product NDC
67046-489
11-digit product format
670460489
Labeler code
67046
Product ID
67046-489_bc6e059d-1951-4fa3-b904-230d4165724d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
NDA021487
Marketing category
NDA
Marketing start
2010-03-19
Marketing end
0000-00-00
Substance
MEMANTINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67046-489IInactivated by FDA2026-07-31
excluded packagepackage67046-48967046-489-60IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021487-001NAMENDAMEMANTINE HYDROCHLORIDE5MGTABLET / ORALRLD2003-10-16
N021487-002NAMENDAMEMANTINE HYDROCHLORIDE10MGTABLET / ORALRLD2003-10-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021487-001NAMENDA5MGTABLET / ORALRLD2003-10-16a50c72e98297…
2026-08-01 22:54:322026-06N021487-002NAMENDA10MGTABLET / ORALRLD2003-10-16a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
memantine hydrochlorideMEMANTINE HYDROCHLORIDECardinal Health 107, LLCe5754973-e73b-4a25-abb4-80f91880f0182026-06-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 021487
application number: NDA021487
memantine hydrochlorideMEMANTINE HYDROCHLORIDEActavis Pharma, Inc.72973b46-f307-4a9e-8fb1-ad2cbccfd7362018-11-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 021487
application number: NDA021487
memantine hydrochlorideMEMANTINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCc8f5c20b-4573-44c5-89fc-4da11b2e1fe12017-11-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 021487
application number: NDA021487

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
941773f8-a40e-0684-da08-ff9a143e6368Product name720231219
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-489-602019-10-21C16284748780-1956f9ecf-bc58-621f-e053-dbdaa90a74adbc6e059d-1951-4fa3-b904-230d4165724d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-489-60Namenda60 in 1 BLISTER PACKTABLET601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CONTRACT PHARMACY SERVICES-PA]1
MEMANTINEACTIVE MOIETYW8O17SJF3TNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CONTRACT PHARMACY SERVICES-PA]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CONTRACT PHARMACY SERVICES-PA]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WONAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CONTRACT PHARMACY SERVICES-PA]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CONTRACT PHARMACY SERVICES-PA]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-489NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20100322_bc6e059d-1951-4fa3-b904-230d4165724d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSNbc6e059d-1951-4fa3-b904-230d4165724d1
996563Namenda 10 MG Oral TabletPSNbc6e059d-1951-4fa3-b904-230d4165724d1
996563memantine hydrochloride 10 MG Oral Tablet [Namenda]SBDbc6e059d-1951-4fa3-b904-230d4165724d1
996561memantine hydrochloride 10 MG Oral TabletSCDbc6e059d-1951-4fa3-b904-230d4165724d1
996563Namenda 10 MG Oral TabletSYbc6e059d-1951-4fa3-b904-230d4165724d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-489-606704604896060 in 1 BLISTER PACKHistorical