FDA.reportPublic FDA data

Namenda XR

Product NDC
68151-5829
11-digit product format
681515829
Labeler code
68151
Product ID
68151-5829_3a73e786-fa25-4c07-af56-2b4022b2cd2e
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

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
68151-5829-82020-01-31C16284748780-19d75b9d0-ee2d-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, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-5829-8Namenda XR1 in 1 BOTTLECAPSULE, EXTENDED RELEASE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-5829NAMENDA XR (MEMANTINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE NAMENDA XR (MEMANTINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]6Legacy NDC, 1 package rows20180228_1fa2b7bc-94e5-4566-a7c5-419f8fd393a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996594memantine HCl 14 MG 24HR Extended Release Oral CapsulePSN1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
996609memantine HCl 28 MG 24HR Extended Release Oral CapsulePSN1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
996597Namenda XR 14 MG 24HR Extended Release Oral CapsulePSN1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
996611Namenda XR 28 MG 24HR Extended Release Oral CapsulePSN1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
99659724 HR memantine hydrochloride 14 MG Extended Release Oral Capsule [Namenda]SBD1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
99661124 HR memantine hydrochloride 28 MG Extended Release Oral Capsule [Namenda]SBD1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
99659424 HR memantine hydrochloride 14 MG Extended Release Oral CapsuleSCD1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
99660924 HR memantine hydrochloride 28 MG Extended Release Oral CapsuleSCD1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
99659724 HR Namenda 14 MG Extended Release Oral CapsuleSY1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
99661124 HR Namenda 28 MG Extended Release Oral CapsuleSY1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
996594memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSY1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
996609memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSY1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
996597Namenda XR 14 MG 24 HR Extended Release Oral CapsuleSY1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
996611Namenda XR 28 MG 24 HR Extended Release Oral CapsuleSY1fa2b7bc-94e5-4566-a7c5-419f8fd393a76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-5829-8681515829081 in 1 BOTTLEHistorical