FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
50268-588
11-digit product format
502680588
Labeler code
50268
Product ID
50268-588_47e7cea9-cd6c-40d4-e063-6294a90a9e8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA200022
Marketing category
ANDA
Marketing start
2024-02-20
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
2027-12-31
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
A200022-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13
A200022-002MEMANTINE 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
A200022-001AB
A200022-002AB

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 22:54:322026-06A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13a50c72e98297…
2026-08-01 22:54:322026-06A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A200022-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A200022-002AB1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC47e4a696-fe2a-c905-e063-6294a90a74152026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200022
application number: ANDA200022
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAvPAK11d27c75-fdc0-f9da-e063-6394a90ac6b02026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200022
application number: ANDA200022
ndc (product): 50268-588
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutionsca619439-f4ca-43f1-9261-9aa2b6dc74502024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200022
application number: ANDA200022
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutions2fdf0b2b-0337-472d-83ec-075c17c9b0d02023-11-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200022
application number: ANDA200022
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.ff74edcb-d7ed-4b70-8f22-4cb5ccc58f902020-12-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200022
application number: ANDA200022

Additional Listing Data#

Finished product
Yes
Brand name base
Memantine Hydrochloride
Listing expiration
2027-12-31

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
11d27c75-fdc0-f9da-e063-6394a90ac6b0Available 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-588-11Memantine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED12
50268-588-13Memantine Hydrochloride30 in 1 BOXTABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-588-11EA - Each50268-588c2d0a6e5-bdf8-4294-b619-f57ce9744e4112024-04-05
50268-588-13EA - Each50268-5889400f7e3-4f66-4955-8542-533e9cc7889812024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-588MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AVPAK]1Current NDC, 2 package rows20240307_11d27c75-fdc0-f9da-e063-6394a90ac6b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN11d27c75-fdc0-f9da-e063-6394a90ac6b02
996571memantine HCl 5 MG Oral TabletPSN11d27c75-fdc0-f9da-e063-6394a90ac6b02
996561memantine hydrochloride 10 MG Oral TabletSCD11d27c75-fdc0-f9da-e063-6394a90ac6b02
996571memantine hydrochloride 5 MG Oral TabletSCD11d27c75-fdc0-f9da-e063-6394a90ac6b02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-588-11502680588111 in 1 BLISTER PACKHistorical
50268-588-135026805881330 BLISTER PACK in 1 BOX (50268-588-13) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-588-11) 30 blister pack2024-02-20NoNoCurrent