Memantine Hydrochloride

Product NDC
60505-6211
11-digit product format
605056211
Labeler code
60505
Product ID
60505-6211_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
28 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
60505-6211-3EA - Each60505-6211ab69fa80-450e-4065-82c3-f2133cecfd2112019-06-19
60505-6211-9EA - Each60505-62111d3e4dc9-bc27-4c93-93f4-b016a104085e12019-06-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-6211-36050562110330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-6211-3) 2019-05-090000-00-00NoNoCurrent
60505-6211-96050562110990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-6211-9) 2019-05-090000-00-00NoNoCurrent