FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
27241-070
11-digit product format
272410070
Labeler code
27241
Product ID
27241-070_078be4f6-c883-4178-be61-834fb9d5e4f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA206528
Marketing category
ANDA
Marketing start
2015-08-27
Substance
MEMANTINE HYDROCHLORIDE
Active strength
5 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
A206528-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-30
A206528-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206528-001AB
A206528-002AB

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 22:54:322026-06A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-30a50c72e98297…
2026-08-01 22:54:322026-06A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206528-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A206528-002AB1a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.becb09dc-174d-4817-88d4-f38c8adcd3092026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackafc07196-be28-4521-afc0-d4aa5b6fd46d2026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAjanta Pharma USA Inc.292671f2-f221-4a3d-a110-a266a9527e042025-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
ndc (product): 27241-070
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC30b8b982-db74-7cf4-e063-6394a90a3a6b2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
Memantine HCLMEMANTINE HCLDirect_Rx1289db0e-5179-d157-e063-6294a90ab7582024-02-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutionsd1c2ec99-7183-46e3-a96e-4f23e20b8b062023-04-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE5 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
292671f2-f221-4a3d-a110-a266a9527e04Available 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
27241-070-05Memantine Hydrochloride500 in 1 BOTTLETABLET5009
27241-070-06Memantine Hydrochloride60 in 1 BOTTLETABLET609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-070-06EA - Each27241-0702e4617c0-4f21-4eef-bdb2-6405e7d9830112016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-070MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE ) TABLET [AJANTA PHARMA USA INC.]8Current NDC, Legacy NDC, 2 package rows20211228_292671f2-f221-4a3d-a110-a266a9527e04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN292671f2-f221-4a3d-a110-a266a9527e049
996571memantine HCl 5 MG Oral TabletPSN292671f2-f221-4a3d-a110-a266a9527e049
996561memantine hydrochloride 10 MG Oral TabletSCD292671f2-f221-4a3d-a110-a266a9527e049
996571memantine hydrochloride 5 MG Oral TabletSCD292671f2-f221-4a3d-a110-a266a9527e049

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-070-0527241007005500 TABLET in 1 BOTTLE (27241-070-05) 500 tablet2015-08-270000-00-00NoNoCurrent
27241-070-062724100700660 TABLET in 1 BOTTLE (27241-070-06) 60 tablet2015-08-270000-00-00NoNoCurrent