Memantine Hydrochloride

Product NDC
43975-264
11-digit product format
439750264
Labeler code
43975
Product ID
43975-264_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
14 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
43975-264-03EA - Each43975-2640fe06a4f-cc62-4caf-880a-dd83abc8767f12020-06-05
43975-264-09EA - Each43975-26463798886-71a3-4352-a189-bb104889f49212020-06-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43975-264-034397502640330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-264-03) 2020-05-190000-00-00NoNoCurrent
43975-264-094397502640990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-264-09) 2020-05-190000-00-00NoNoCurrent