Memantine Hydrochloride

Product NDC
63629-9286
11-digit product format
636299286
Labeler code
63629
Product ID
63629-9286_2066c36c-e2df-4fd5-94f1-b9e01240c08c
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
63629-9286-16362992860130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-9286-1) 2022-06-060000-00-00NoNoCurrent