Memantine Hydrochloride

Product NDC
71335-0346
11-digit product format
713350346
Labeler code
71335
Product ID
71335-0346_1183728c-e0ed-4c18-b157-071d94d2c38a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206528
Marketing category
ANDA
Marketing start
2015-08-27
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0346-17133503460130 TABLET in 1 BOTTLE (71335-0346-1) 30 tablet2017-08-180000-00-00NoNoCurrent
71335-0346-27133503460228 TABLET in 1 BOTTLE (71335-0346-2) 28 tablet2017-08-180000-00-00NoNoCurrent