Memantine Hydrochloride

Product NDC
60505-6210
11-digit product format
605056210
Labeler code
60505
Product ID
60505-6210_6cfcef62-aadf-4c12-9fa7-2e8cb65f8d54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Apotex Corp
Application
NDA022525
Marketing category
NDA
Marketing start
2019-05-09
Marketing end
0000-00-00
Substance
MEMANTINE HYDROCHLORIDE
Active strength
21 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6210-3EA - Each60505-62102e01f522-1c5c-4fae-a742-1c22d428061612019-06-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-6210-36050562100330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-6210-3) 2019-05-090000-00-00NoNoCurrent