FDA.reportPublic FDA data

memantine hydrochloride

Product NDC
47335-034
11-digit product format
473350034
Labeler code
47335
Product ID
47335-034_1f7269e6-8156-45be-ba04-9f81cfe7e409
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA205905
Marketing category
ANDA
Marketing start
2013-06-14
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
No
Listing certified through
2020-12-31
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
47335-034-182025-01-30C16284748780-12cef2736-7e80-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. MEMANTINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 2003
47335-034-812025-01-30C16284748780-12cef2736-7e80-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. MEMANTINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 2003
47335-034-832025-01-30C16284748780-12cef2736-7e80-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. MEMANTINE HYDROCHLORIDE extended-release capsules, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-034-18memantine hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10006
47335-034-81memantine hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE906
47335-034-83memantine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-034MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Legacy NDC, 3 package rows20191228_e16a8aa8-f5fd-4db8-abb2-d54e742bb95f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996594memantine HCl 14 MG 24HR Extended Release Oral CapsulePSNe16a8aa8-f5fd-4db8-abb2-d54e742bb95f6
996603memantine HCl 21 MG 24HR Extended Release Oral CapsulePSNe16a8aa8-f5fd-4db8-abb2-d54e742bb95f6
996609memantine HCl 28 MG 24HR Extended Release Oral CapsulePSNe16a8aa8-f5fd-4db8-abb2-d54e742bb95f6
996615memantine HCl 7 MG 24HR Extended Release Oral CapsulePSNe16a8aa8-f5fd-4db8-abb2-d54e742bb95f6
99659424 HR memantine hydrochloride 14 MG Extended Release Oral CapsuleSCDe16a8aa8-f5fd-4db8-abb2-d54e742bb95f6
99660324 HR memantine hydrochloride 21 MG Extended Release Oral CapsuleSCDe16a8aa8-f5fd-4db8-abb2-d54e742bb95f6
99660924 HR memantine hydrochloride 28 MG Extended Release Oral CapsuleSCDe16a8aa8-f5fd-4db8-abb2-d54e742bb95f6
99661524 HR memantine hydrochloride 7 MG Extended Release Oral CapsuleSCDe16a8aa8-f5fd-4db8-abb2-d54e742bb95f6
996594memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSYe16a8aa8-f5fd-4db8-abb2-d54e742bb95f6
996603memantine hydrochloride 21 MG 24 HR Extended Release Oral CapsuleSYe16a8aa8-f5fd-4db8-abb2-d54e742bb95f6
996609memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSYe16a8aa8-f5fd-4db8-abb2-d54e742bb95f6
996615memantine hydrochloride 7 MG 24 HR Extended Release Oral CapsuleSYe16a8aa8-f5fd-4db8-abb2-d54e742bb95f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-034-18473350034181000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-034-18) 2013-06-140000-00-00NoNoCurrent
47335-034-814733500348190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-034-81) 2013-06-140000-00-00NoNoCurrent
47335-034-834733500348330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-034-83) 2013-06-140000-00-00NoNoCurrent