Memantine Hydrochloride

Product NDC
68788-7165
11-digit product format
687887165
Labeler code
68788
Product ID
68788-7165_00698ee1-6ba4-4581-90e8-3954a7ba1cb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA202840
Marketing category
ANDA
Marketing start
2018-06-05
Marketing end
0000-00-00
Substance
MEMANTINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7165-3EA - Each68788-7165910d29d2-c56f-4c9b-834e-0ed892f4cb4312018-08-13
68788-7165-6EA - Each68788-71650ef16a8a-28dc-4e2e-8d4b-5e093c03686412018-08-13
68788-7165-9EA - Each68788-71653f43b801-e496-42e9-987c-d0174608037812018-08-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7165-36878871650330 TABLET in 1 BOTTLE (68788-7165-3) 30 tablet2018-06-050000-00-00NoNoCurrent
68788-7165-66878871650660 TABLET in 1 BOTTLE (68788-7165-6) 60 tablet2018-06-050000-00-00NoNoCurrent
68788-7165-96878871650990 TABLET in 1 BOTTLE (68788-7165-9) 90 tablet2018-06-050000-00-00NoNoCurrent