Memantine Hydrochloride

Product NDC
10370-349
11-digit product format
103700349
Labeler code
10370
Product ID
10370-349_84bb0482-3d0a-4f64-a2cb-865fe4becd6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA205784
Marketing category
ANDA
Marketing start
2018-02-20
Marketing end
2023-06-30
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
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10370-349-09EA - Each10370-349b76bd3ba-7022-497b-b914-385fd32a86e612018-03-08
10370-349-11EA - Each10370-34920e6029f-7f7e-4f3c-b3f2-a8ccc00b27af12018-03-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10370-349-091037003490990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-349-09) 2018-02-200000-00-00NoNoCurrent
10370-349-111037003491130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-349-11) 2018-02-200000-00-00NoNoCurrent