FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
62332-076
11-digit product format
623320076
Labeler code
62332
Product ID
62332-076_9792a0a6-a48e-4998-9f5a-c9eaa144edea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA200891
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
A200891-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13
A200891-002MEMANTINE 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
A200891-001AB
A200891-002AB

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 22:54:322026-06A200891-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13a50c72e98297…
2026-08-01 22:54:322026-06A200891-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A200891-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A200891-002AB1a50c72e98297…

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 HYDROCHLORIDEAlembic Pharmaceuticals Limitedb86c0f6e-480b-40e7-aa4d-21bd0659101d2023-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200891
application number: ANDA200891
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.af2b73da-1be4-4b7f-929b-acb3b9a10f782021-10-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200891
application number: ANDA200891
ndc (product): 62332-076

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
af2b73da-1be4-4b7f-929b-acb3b9a10f78Available 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
62332-076-10Memantine Hydrochloride100 in 1 CARTONTABLET, COATED10013
62332-076-20Memantine Hydrochloride20 in 1 BOTTLETABLET, COATED2013
62332-076-30Memantine Hydrochloride30 in 1 BOTTLETABLET, COATED3013
62332-076-31Memantine Hydrochloride100 in 1 BOTTLETABLET, COATED10013
62332-076-42Memantine Hydrochloride3000 in 1 BOTTLETABLET, COATED300013
62332-076-60Memantine Hydrochloride60 in 1 BOTTLETABLET, COATED6013
62332-076-71Memantine Hydrochloride500 in 1 BOTTLETABLET, COATED50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-076-31EA - Each62332-076539368e0-e5cb-473a-ac4a-74423e13a28112017-03-06
62332-076-42EA - Each62332-076f6c50fa4-0642-442b-a027-91422e64246412016-07-19
62332-076-60EA - Each62332-076b3c5a252-d2c9-40a6-9055-771ed64b8ef412015-11-12
62332-076-71EA - Each62332-076553b54e7-db8b-4474-9047-c4cabf696e8912018-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
MEMANTINEACTIVE MOIETYW8O17SJF3TMEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UMEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-076MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 7 package rows20211012_af2b73da-1be4-4b7f-929b-acb3b9a10f78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSNaf2b73da-1be4-4b7f-929b-acb3b9a10f7813
996571memantine HCl 5 MG Oral TabletPSNaf2b73da-1be4-4b7f-929b-acb3b9a10f7813
996561memantine hydrochloride 10 MG Oral TabletSCDaf2b73da-1be4-4b7f-929b-acb3b9a10f7813
996571memantine hydrochloride 5 MG Oral TabletSCDaf2b73da-1be4-4b7f-929b-acb3b9a10f7813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-076-1062332007610100 TABLET, COATED in 1 CARTON (62332-076-10) 2015-10-130000-00-00NoNoCurrent
62332-076-206233200762020 TABLET, COATED in 1 BOTTLE (62332-076-20) 2015-10-130000-00-00NoNoCurrent
62332-076-306233200763030 TABLET, COATED in 1 BOTTLE (62332-076-30) 2015-10-130000-00-00NoNoCurrent
62332-076-3162332007631100 TABLET, COATED in 1 BOTTLE (62332-076-31) 2015-10-130000-00-00NoNoCurrent
62332-076-42623320076423000 TABLET, COATED in 1 BOTTLE (62332-076-42) 2015-10-130000-00-00NoNoCurrent
62332-076-606233200766060 TABLET, COATED in 1 BOTTLE (62332-076-60) 2015-10-130000-00-00NoNoCurrent
62332-076-7162332007671500 TABLET, COATED in 1 BOTTLE (62332-076-71) 2015-10-130000-00-00NoNoCurrent