Memantine Hydrochloride

Product NDC
43975-243
11-digit product format
439750243
Labeler code
43975
Product ID
43975-243_b0907384-1fef-433a-9d3b-3bd35bcdc3ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA205365
Marketing category
ANDA
Marketing start
2020-05-19
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
43975-243-03EA - Each43975-2434e64a884-4f11-446d-b042-949d556d9f5512020-06-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43975-243-034397502430330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-243-03) 2020-05-190000-00-00NoNoCurrent