FDA.reportPublic FDA data

Namenda

Product NDC
68151-5817
11-digit product format
681515817
Labeler code
68151
Product ID
68151-5817_899dcc94-a2aa-4a1b-b3c6-7c61ed6cd962
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA022525
Marketing category
NDA
Marketing start
2011-10-31
Marketing end
0000-00-00
Substance
MEMANTINE HYDROCHLORIDE
Active strength
28 mg/1
Pharmacologic classes
NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68151-5817IInactivated by FDA2026-08-03
excluded packagepackage68151-581768151-5817-8IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022525-001NAMENDA XRMEMANTINE HYDROCHLORIDE7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21
N022525-002NAMENDA XRMEMANTINE HYDROCHLORIDE14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21
N022525-003NAMENDA XRMEMANTINE HYDROCHLORIDE21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21
N022525-004NAMENDA XRMEMANTINE HYDROCHLORIDE28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022525-00180390092029-03-24U-5392011-11-16
N022525-0018039009*PED2029-09-24Pediatric extension
N022525-00280390092029-03-24U-539
N022525-0028039009*PED2029-09-24Pediatric extension
N022525-00380390092029-03-24U-539
N022525-0038039009*PED2029-09-24Pediatric extension
N022525-00480390092029-03-24U-539
N022525-0048039009*PED2029-09-24Pediatric extension

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 22:54:322026-06N022525-001NAMENDA XR7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21a50c72e98297…
2026-08-01 22:54:322026-06N022525-002NAMENDA XR14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21a50c72e98297…
2026-08-01 22:54:322026-06N022525-003NAMENDA XR21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21a50c72e98297…
2026-08-01 22:54:322026-06N022525-004NAMENDA XR28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N022525-00180390092029-03-24U-5392011-11-16a50c72e98297…
2026-08-01 22:54:322026-06N022525-0018039009*PED2029-09-24Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022525-00280390092029-03-24U-539a50c72e98297…
2026-08-01 22:54:322026-06N022525-0028039009*PED2029-09-24Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022525-00380390092029-03-24U-539a50c72e98297…
2026-08-01 22:54:322026-06N022525-0038039009*PED2029-09-24Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022525-00480390092029-03-24U-539a50c72e98297…
2026-08-01 22:54:322026-06N022525-0048039009*PED2029-09-24Pediatric extensiona50c72e98297…

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
68151-5817-82020-01-31C16284748780-19d75b9d0-06c4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NAMENDA XR capsules safely and effectively. See full prescribing information for NAMENDA XR capsules. NAMENDA XR (memantine hydrochloride) extended release capsules Initial U.S. Approval: 2003 ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-5817-8Namenda XR1 in 1 CUPCAPSULE, EXTENDED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-5817NAMENDA XR (MEMANTINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20160304_617dcd31-3215-4dd8-9b6e-d888d3bf30f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996609memantine HCl 28 MG 24HR Extended Release Oral CapsulePSN617dcd31-3215-4dd8-9b6e-d888d3bf30f32
996611Namenda XR 28 MG 24HR Extended Release Oral CapsulePSN617dcd31-3215-4dd8-9b6e-d888d3bf30f32
99661124 HR memantine hydrochloride 28 MG Extended Release Oral Capsule [Namenda]SBD617dcd31-3215-4dd8-9b6e-d888d3bf30f32
99660924 HR memantine hydrochloride 28 MG Extended Release Oral CapsuleSCD617dcd31-3215-4dd8-9b6e-d888d3bf30f32
99661124 HR Namenda 28 MG Extended Release Oral CapsuleSY617dcd31-3215-4dd8-9b6e-d888d3bf30f32
996609memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSY617dcd31-3215-4dd8-9b6e-d888d3bf30f32
996611Namenda XR 28 MG 24 HR Extended Release Oral CapsuleSY617dcd31-3215-4dd8-9b6e-d888d3bf30f32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-5817-8681515817081 in 1 CUPHistorical