NDC 43353-165

Memantine Hydrochloride

Memantine Hydrochloride

Memantine Hydrochloride is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Memantine Hydrochloride.

Product ID43353-165_bd5eaa03-d2d2-4af4-855f-a3fa51a58b72
NDC43353-165
Product TypeHuman Prescription Drug
Proprietary NameMemantine Hydrochloride
Generic NameMemantine Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2015-10-13
Marketing CategoryANDA / ANDA
Application NumberANDA200891
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameMEMANTINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesNMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43353-165-18

3000 TABLET, COATED in 1 BOTTLE (43353-165-18)
Marketing Start Date2016-03-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-165-18 [43353016518]

Memantine Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA200891
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-30

NDC 43353-165-53 [43353016553]

Memantine Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA200891
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-29

Drug Details

Active Ingredients

IngredientStrength
MEMANTINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:7c093eec-e73f-42aa-acef-101e3d6d039e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996561
  • Pharmacological Class

    • NMDA Receptor Antagonists [MoA]
    • N-methyl-D-aspartate Receptor Antagonist [EPC]
    • NMDA Receptor Antagonists [MoA]
    • N-methyl-D-aspartate Receptor Antagonist [EPC]

    NDC Crossover Matching brand name "Memantine Hydrochloride" or generic name "Memantine Hydrochloride"

    NDCBrand NameGeneric Name
    0121-0850Memantine HydrochlorideMemantine Hydrochloride
    0378-1103Memantine Hydrochloridememantine
    0378-1104Memantine Hydrochloridememantine
    0378-5435Memantine Hydrochloridememantine
    0378-5436Memantine Hydrochloridememantine
    0378-5437Memantine Hydrochloridememantine
    0378-5438Memantine Hydrochloridememantine
    0527-1221Memantine HydrochlorideMemantine Hydrochloride
    68180-246memantine hydrochloridememantine hydrochloride
    68180-229Memantine hydrochlorideMemantine hydrochloride
    68180-230Memantine hydrochlorideMemantine hydrochloride
    68180-248memantine hydrochloridememantine hydrochloride
    68180-247memantine hydrochloridememantine hydrochloride
    68180-249memantine hydrochloridememantine hydrochloride
    68382-546Memantine hydrochlorideMemantine hydrochloride
    68382-548Memantine hydrochlorideMemantine hydrochloride
    68382-388Memantine HydrochlorideMemantine Hydrochloride
    68382-389Memantine HydrochlorideMemantine Hydrochloride
    68382-547Memantine hydrochlorideMemantine hydrochloride
    68382-549Memantine hydrochlorideMemantine hydrochloride
    68788-7165Memantine HydrochlorideMemantine Hydrochloride
    0527-1222Memantine HydrochlorideMemantine Hydrochloride
    0527-1943Memantine HydrochlorideMemantine Hydrochloride
    0591-3870memantine hydrochloridememantine hydrochloride
    0591-3900memantine hydrochloridememantine hydrochloride
    0591-3875memantine hydrochloridememantine hydrochloride
    70771-1323Memantine hydrochlorideMemantine hydrochloride
    70771-1119Memantine HydrochlorideMemantine Hydrochloride
    70771-1322Memantine hydrochlorideMemantine hydrochloride
    70771-1321Memantine hydrochlorideMemantine hydrochloride
    70771-1324Memantine hydrochlorideMemantine hydrochloride
    70771-1120Memantine HydrochlorideMemantine Hydrochloride
    71335-0346Memantine HydrochlorideMemantine Hydrochloride
    71610-011memantine hydrochloridememantine hydrochloride
    72578-004Memantine HydrochlorideMemantine Hydrochloride
    72578-003Memantine HydrochlorideMemantine Hydrochloride
    0615-8264memantine hydrochloridememantine hydrochloride
    0832-1113Memantine HydrochlorideMemantine Hydrochloride
    0832-1112Memantine HydrochlorideMemantine Hydrochloride
    0904-6736memantine hydrochloridememantine hydrochloride
    0904-6735memantine hydrochloridememantine hydrochloride
    10370-347Memantine HydrochlorideMemantine Hydrochloride
    10370-348Memantine HydrochlorideMemantine Hydrochloride
    10370-349Memantine HydrochlorideMemantine Hydrochloride
    10370-346Memantine HydrochlorideMemantine Hydrochloride
    13668-222Memantine hydrochlorideMemantine hydrochloride
    13668-223Memantine hydrochlorideMemantine hydrochloride
    13668-573Memantine HydrochlorideMemantine Hydrochloride
    27241-071Memantine HydrochlorideMemantine Hydrochloride
    27241-070Memantine HydrochlorideMemantine Hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.