FDA.reportPublic FDA data

Memantine hydrochloride

Product NDC
52605-072
11-digit product format
526050072
Labeler code
52605
Product ID
52605-072_4fe4f372-10c2-42ca-bc69-d78a489672b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
POLYGEN PHARMACEUTICALS INC.
Application
ANDA210587
Marketing category
ANDA
Marketing start
2021-07-01
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
A210587-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2020-12-11
A210587-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2020-12-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210587-001AB
A210587-002AB

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 22:54:322026-06A210587-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2020-12-11a50c72e98297…
2026-08-01 22:54:322026-06A210587-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2020-12-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A210587-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A210587-002AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
memantine hydrochlorideMEMANTINE HYDROCHLORIDEPOLYGEN PHARMACEUTICALS INC.c343b0c5-3bfc-4b94-9483-a56924f6dcdb2022-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210587
application number: ANDA210587
ndc (product): 52605-072

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
c343b0c5-3bfc-4b94-9483-a56924f6dcdbAvailable 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
52605-072-10Memantine hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10004
52605-072-13Memantine hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
52605-072-16Memantine hydrochloride60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52605-072MEMANTINE HYDROCHLORIDE TABLET, FILM COATED MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [POLYGEN PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 3 package rows20221202_c343b0c5-3bfc-4b94-9483-a56924f6dcdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSNc343b0c5-3bfc-4b94-9483-a56924f6dcdb4
996571memantine HCl 5 MG Oral TabletPSNc343b0c5-3bfc-4b94-9483-a56924f6dcdb4
996561memantine hydrochloride 10 MG Oral TabletSCDc343b0c5-3bfc-4b94-9483-a56924f6dcdb4
996571memantine hydrochloride 5 MG Oral TabletSCDc343b0c5-3bfc-4b94-9483-a56924f6dcdb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52605-072-10526050072101000 TABLET, FILM COATED in 1 BOTTLE (52605-072-10) 2021-07-010000-00-00NoNoCurrent
52605-072-135260500721330 TABLET, FILM COATED in 1 BOTTLE (52605-072-13) 2021-07-010000-00-00NoNoCurrent
52605-072-165260500721660 TABLET, FILM COATED in 1 BOTTLE (52605-072-16) 2021-07-010000-00-00NoNoCurrent