memantine hydrochloride

Product NDC
55154-2667
11-digit product format
551542667
Labeler code
55154
Product ID
55154-2667_3c3a9220-1676-4303-97c9-c939ff60477c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
NDA021487
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-04-01
Marketing end
2028-02-29
Substance
MEMANTINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

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
ndc (product): 55154-2667
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

Additional Listing Data#

Finished product
Yes
Brand name base
memantine hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JY0WD0UA60Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996561Internal RxNorm lookup
996571Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e5754973-e73b-4a25-abb4-80f91880f018Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-2667-0memantine hydrochloride10 in 1 BAGTABLET107
55154-2667-0memantine hydrochloride1 in 1 BLISTER PACKTABLET17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-2667MEMANTINE HYDROCHLORIDE TABLET [CARDINAL HEALTH 107, LLC]7Current NDC, Legacy NDC, 2 package rows20250131_e5754973-e73b-4a25-abb4-80f91880f018.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSNe5754973-e73b-4a25-abb4-80f91880f0187
996571memantine HCl 5 MG Oral TabletPSNe5754973-e73b-4a25-abb4-80f91880f0187
996561memantine hydrochloride 10 MG Oral TabletSCDe5754973-e73b-4a25-abb4-80f91880f0187
996571memantine hydrochloride 5 MG Oral TabletSCDe5754973-e73b-4a25-abb4-80f91880f0187

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-2667-05515426670010 BLISTER PACK in 1 BAG (55154-2667-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2015-04-012028-02-29NoNoCurrent