FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
33342-298
11-digit product format
333420298
Labeler code
33342
Product ID
33342-298_672222e3-12b9-488f-a5ee-c47736d65cce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA202840
Marketing category
ANDA
Marketing start
2015-10-13
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
Listing certified through
2026-12-31
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
A202840-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13
A202840-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A202840-001AB
A202840-002AB

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 22:54:322026-06A202840-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13a50c72e98297…
2026-08-01 22:54:322026-06A202840-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202840-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202840-002AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutions66db6d61-cf1d-46ca-a645-19e9a20f46172023-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202840
application number: ANDA202840
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEMacleods Pharmaceuticals Limited989fa756-7d70-4ea7-bb5e-f4395e48589d2022-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202840
application number: ANDA202840
ndc (product): 33342-298

Additional Listing Data#

Finished product
Yes
Brand name base
Memantine Hydrochloride
Listing expiration
2026-12-31

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
989fa756-7d70-4ea7-bb5e-f4395e48589dAvailable 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
33342-298-09Memantine Hydrochloride60 in 1 BOTTLETABLET606
33342-298-12Memantine Hydrochloride10 in 1 BLISTER PACKTABLET106
33342-298-12Memantine Hydrochloride10 in 1 CARTONTABLET106
33342-298-15Memantine Hydrochloride500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-298-09EA - Each33342-298bb6510a6-4cf9-4061-bcdf-43b8dfa3fd6a12015-11-12
33342-298-15EA - Each33342-2986a6a07dd-aecb-4539-bbfa-f77237f410e012015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60MEMANTINE HYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]2
MEMANTINEACTIVE MOIETYW8O17SJF3TMEMANTINE HYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-298MEMANTINE HYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]6Current NDC, Legacy NDC, 4 package rows20230101_989fa756-7d70-4ea7-bb5e-f4395e48589d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN989fa756-7d70-4ea7-bb5e-f4395e48589d6
996571memantine HCl 5 MG Oral TabletPSN989fa756-7d70-4ea7-bb5e-f4395e48589d6
996561memantine hydrochloride 10 MG Oral TabletSCD989fa756-7d70-4ea7-bb5e-f4395e48589d6
996571memantine hydrochloride 5 MG Oral TabletSCD989fa756-7d70-4ea7-bb5e-f4395e48589d6
996561memantine HCl 10 MG Oral TabletPSN66db6d61-cf1d-46ca-a645-19e9a20f46175
996561memantine hydrochloride 10 MG Oral TabletSCD66db6d61-cf1d-46ca-a645-19e9a20f46175

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-298-093334202980960 TABLET in 1 BOTTLE (33342-298-09) 60 tablet2015-10-130000-00-00NoNoCurrent
33342-298-123334202981210 BLISTER PACK in 1 CARTON (33342-298-12) / 10 TABLET in 1 BLISTER PACK10 blister pack2015-10-130000-00-00NoNoCurrent
33342-298-1533342029815500 TABLET in 1 BOTTLE (33342-298-15) 500 tablet2015-10-130000-00-00NoNoCurrent