Memantine Hydrochloride

Product NDC
10370-348
11-digit product format
103700348
Labeler code
10370
Product ID
10370-348_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
21 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10370-348-112022-09-23C16284748780-1e4f33bdf-a54c-d8a0-e053-dadaa90a6e4ea861df49-c5ee-40ba-9027-b2371b91f6f3
10370-348-112022-07-29C16284748780-1e4f33bdf-a54c-d8a0-e053-dadaa90a6e4ea861df49-c5ee-40ba-9027-b2371b91f6f3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10370-348-11EA - Each10370-3488c89caf2-16ab-444c-a198-25d8a6343d1a12018-03-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10370-348-111037003481130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-348-11) 2018-02-200000-00-00NoNoCurrent