FDA.reportPublic FDA data

Namenda

Product NDC
0456-3200
Requested package NDC
0456-3200-14
11-digit product format
004563200
Labeler code
0456
Product ID
0456-3200_d2d531d0-0380-4b22-90e8-ca93627b7900
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
KIT
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA021487
Marketing category
NDA
Marketing start
2003-10-16
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0456-32000456-3200-14DDiscontinued by firm2026-07-31

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0456-3200-14EA - Each0456-32007f73ee97-d9a5-4bd8-ab51-93d6855f88a712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
memantineACTIVE MOIETYW8O17SJF3TNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
FD&C blue No. 2INACTIVE INGREDIENTL06K8R7DQKNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
glycerinINACTIVE INGREDIENTPDC6A3C0OXNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
hypromellosesINACTIVE INGREDIENT3NXW29V3WONAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
magnesium stearateINACTIVE INGREDIENT70097M6I30NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
sorbitolINACTIVE INGREDIENT506T60A25RNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
talcINACTIVE INGREDIENT7SEV7J4R1UNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) SOLUTION NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC. ]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0456-3200NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET NAMENDA (MEMANTINE HYDROCHLORIDE) KIT [ALLERGAN, INC.]19Legacy NDC20241220_b9f27baf-aa2a-443a-9ef5-e002d23407ba.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0456-3200-14004563200141 KIT in 1 BLISTER PACK (0456-3200-14) 1 kit2003-10-160000-00-00NoNoCurrent