Memantine Hydrochloride

Product NDC
0527-1222
11-digit product format
005271222
Labeler code
0527
Product ID
0527-1222_5931403d-152d-43b3-b6df-941c580affa8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA207236
Marketing category
ANDA
Marketing start
2016-11-10
Marketing end
0000-00-00
Substance
MEMANTINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1222-05EA - Each0527-122221975011-349a-416d-8941-6a4177dea21c12018-08-13
0527-1222-06EA - Each0527-12229eb3ce1a-ff3a-4ff6-b7b4-a08fee7b59d112018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1222MEMANTINE HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]10Legacy NDC20240704_88b7952b-b58a-495e-aa19-d3392d2e2759.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSNa5c3eba1-604b-4662-a718-0b7ebb9582273
996561memantine hydrochloride 10 MG Oral TabletSCDa5c3eba1-604b-4662-a718-0b7ebb9582273

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1222-0500527122205500 TABLET in 1 BOTTLE, PLASTIC (0527-1222-05) 500 tablet2016-11-100000-00-00NoNoCurrent
0527-1222-060052712220660 TABLET in 1 BOTTLE, PLASTIC (0527-1222-06) 60 tablet2016-11-100000-00-00NoNoCurrent
0527-1222-10005271222101000 TABLET in 1 BOTTLE, PLASTIC (0527-1222-10) 1000 tablet2016-11-100000-00-00NoNoCurrent