FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
67046-458
11-digit product format
670460458
Labeler code
67046
Product ID
67046-458_5a455264-1055-2ddb-e053-2991aa0a66b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA090058
Marketing category
ANDA
Marketing start
2017-09-28
Marketing end
0000-00-00
Substance
MEMANTINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67046-458IInactivated by FDA2026-07-31
excluded packagepackage67046-45867046-458-07IInactivated by FDA2026-07-31
excluded packagepackage67046-45867046-458-14IInactivated by FDA2026-07-31
excluded packagepackage67046-45867046-458-15IInactivated by FDA2026-07-31
excluded packagepackage67046-45867046-458-20IInactivated by FDA2026-07-31
excluded packagepackage67046-45867046-458-21IInactivated by FDA2026-07-31
excluded packagepackage67046-45867046-458-28IInactivated by FDA2026-07-31
excluded packagepackage67046-45867046-458-30IInactivated by FDA2026-07-31
excluded packagepackage67046-45867046-458-60IInactivated by FDA2026-07-31

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
A090058-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-05
A090058-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090058-001AB
A090058-002AB

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 22:54:322026-06A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-05a50c72e98297…
2026-08-01 22:54:322026-06A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090058-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A090058-002AB1a50c72e98297…

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 HYDROCHLORIDEBryant Ranch Prepack2ac7d23c-5f9f-4ffc-ae01-d7099a8a79292024-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090058
application number: ANDA090058
Memantine HydrochlorideMEMANTINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.d1963395-3cf7-4433-bf2c-06295bb1c5b02023-10-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090058
application number: ANDA090058

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-458-072020-01-31C16284748780-19d75b9d0-33c1-f424-e053-dadaa90a57ce458 Memantine 10 mg These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
67046-458-142020-01-31C16284748780-19d75b9d0-33c1-f424-e053-dadaa90a57ce458 Memantine 10 mg These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
67046-458-152020-01-31C16284748780-19d75b9d0-33c1-f424-e053-dadaa90a57ce458 Memantine 10 mg These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
67046-458-202020-01-31C16284748780-19d75b9d0-33c1-f424-e053-dadaa90a57ce458 Memantine 10 mg These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
67046-458-212020-01-31C16284748780-19d75b9d0-33c1-f424-e053-dadaa90a57ce458 Memantine 10 mg These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
67046-458-282020-01-31C16284748780-19d75b9d0-33c1-f424-e053-dadaa90a57ce458 Memantine 10 mg These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
67046-458-302020-01-31C16284748780-19d75b9d0-33c1-f424-e053-dadaa90a57ce458 Memantine 10 mg These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003
67046-458-602020-01-31C16284748780-19d75b9d0-33c1-f424-e053-dadaa90a57ce458 Memantine 10 mg These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-458-07Memantine Hydrochloride7 in 1 BLISTER PACKTABLET, FILM COATED71
67046-458-14Memantine Hydrochloride14 in 1 BLISTER PACKTABLET, FILM COATED141
67046-458-15Memantine Hydrochloride15 in 1 BLISTER PACKTABLET, FILM COATED151
67046-458-20Memantine Hydrochloride20 in 1 BLISTER PACKTABLET, FILM COATED201
67046-458-21Memantine Hydrochloride21 in 1 BLISTER PACKTABLET, FILM COATED211
67046-458-28Memantine Hydrochloride28 in 1 BLISTER PACKTABLET, FILM COATED281
67046-458-30Memantine Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED301
67046-458-60Memantine Hydrochloride60 in 1 BLISTER PACKTABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-458MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170929_5a455264-1054-2ddb-e053-2991aa0a66b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN5a455264-1054-2ddb-e053-2991aa0a66b01
996561memantine hydrochloride 10 MG Oral TabletSCD5a455264-1054-2ddb-e053-2991aa0a66b01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-458-07670460458077 in 1 BLISTER PACKHistorical
67046-458-146704604581414 in 1 BLISTER PACKHistorical
67046-458-156704604581515 in 1 BLISTER PACKHistorical
67046-458-206704604582020 in 1 BLISTER PACKHistorical
67046-458-216704604582121 in 1 BLISTER PACKHistorical
67046-458-286704604582828 in 1 BLISTER PACKHistorical
67046-458-306704604583030 in 1 BLISTER PACKHistorical
67046-458-606704604586060 in 1 BLISTER PACKHistorical