FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
65862-653
Requested package NDC
65862-653-35
11-digit product format
658620653
Labeler code
65862
Product ID
65862-653_12f3b127-625b-4c19-99f5-54f0ddc5cdc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA203175
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

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
unfinished packagepackage65862-65365862-653-35UNFINISHEDActive or certified unfinished drug listing2026-08-03

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
A203175-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13
A203175-002MEMANTINE 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
A203175-001AB
A203175-002AB

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 22:54:322026-06A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13a50c72e98297…
2026-08-01 22:54:322026-06A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203175-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A203175-002AB1a50c72e98297…

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 HYDROCHLORIDEAurobindo Pharma Limitedceb733fa-4526-4b76-ab6a-bd4c5638afff2022-11-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203175
application number: ANDA203175
ndc (product): 65862-653

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
ceb733fa-4526-4b76-ab6a-bd4c5638afffAvailable 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
65862-653-03Memantine Hydrochloride3 in 1 CARTONTABLET, FILM COATED39
65862-653-10Memantine Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED109
65862-653-60Memantine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED609
65862-653-78Memantine Hydrochloride10 in 1 CARTONTABLET, FILM COATED109
65862-653-99Memantine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-653-60EA - Each65862-653c6045050-bc20-4d56-878f-668473a9fdf612015-11-12
65862-653-99EA - Each65862-6534603cbdd-909f-443d-bdd3-148a17f6b7e912016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
MEMANTINEACTIVE MOIETYW8O17SJF3TMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-653MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]9Current NDC, Legacy NDC, 5 package rows20221109_ceb733fa-4526-4b76-ab6a-bd4c5638afff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSNceb733fa-4526-4b76-ab6a-bd4c5638afff9
996571memantine HCl 5 MG Oral TabletPSNceb733fa-4526-4b76-ab6a-bd4c5638afff9
996561memantine hydrochloride 10 MG Oral TabletSCDceb733fa-4526-4b76-ab6a-bd4c5638afff9
996571memantine hydrochloride 5 MG Oral TabletSCDceb733fa-4526-4b76-ab6a-bd4c5638afff9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startStatus
65862-653-35658620653353500 TABLET, FILM COATED in 1 BAG (65862-653-35)13-OCT-15Current