Memantine Hydrochloride

Product NDC
0121-0850
11-digit product format
001210850
Labeler code
0121
Product ID
0121-0850_ed854db7-e85c-fb08-e053-2a95a90aaf92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA204033
Marketing category
ANDA
Marketing start
2019-04-15
Marketing end
2024-05-31
Substance
MEMANTINE HYDROCHLORIDE
Active strength
10 mg/5mL
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
0121-0850-402022-11-15C16284748780-1d6a99b39-848f-a426-e053-dadaa90af4c270855a6f-34d1-4eaa-9793-24a5291957c3
0121-0850-402022-01-28C16284748780-1d6a99b39-848f-a426-e053-dadaa90af4c270855a6f-34d1-4eaa-9793-24a5291957c3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0850-05ML - Milliliter0121-085048051d3b-0536-4bb2-a91a-7688e6918d9512019-09-05
0121-0850-40ML - Milliliter0121-085070ee6438-817f-4f8a-94ec-f0c87dd10c8312019-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0850-40001210850404 TRAY in 1 CASE (0121-0850-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0850-05) 4 tray2019-04-150000-00-00NoNoCurrent