Memantine Hydrochloride

Product NDC
63629-1957
11-digit product format
636291957
Labeler code
63629
Product ID
63629-1957_2ce480a4-bc50-448c-9e4f-02a598709a76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205365
Marketing category
ANDA
Marketing start
2020-05-19
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1957-16362919570190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-1957-1) 2021-01-200000-00-00NoNoCurrent