Memantine Hydrochloride

Product NDC
0527-1221
11-digit product format
005271221
Labeler code
0527
Product ID
0527-1221_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
5 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1221-06EA - Each0527-12218710e148-da43-4401-a00a-ef2f61f257ed12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1221MEMANTINE HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]10Legacy NDC20240704_88b7952b-b58a-495e-aa19-d3392d2e2759.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1221-0500527122105500 TABLET in 1 BOTTLE, PLASTIC (0527-1221-05) 500 tablet2016-11-100000-00-00NoNoCurrent
0527-1221-060052712210660 TABLET in 1 BOTTLE, PLASTIC (0527-1221-06) 60 tablet2016-11-100000-00-00NoNoCurrent
0527-1221-10005271221101000 TABLET in 1 BOTTLE, PLASTIC (0527-1221-10) 1000 tablet2016-11-100000-00-00NoNoCurrent