Memantine Hydrochloride

Product NDC
43975-266
11-digit product format
439750266
Labeler code
43975
Product ID
43975-266_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
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
43975-266-03EA - Each43975-266e2f73a6a-5dfb-40ce-b99c-d1dffe1695c912020-06-05
43975-266-09EA - Each43975-2668ecf8827-4944-49e9-8208-2ce23042766812020-06-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43975-266-034397502660330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-266-03) 2020-05-190000-00-00NoNoCurrent
43975-266-094397502660990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-266-09) 2020-05-190000-00-00NoNoCurrent