NDC 68382-389

Memantine Hydrochloride

Memantine Hydrochloride

Memantine Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Memantine Hydrochloride.

Product ID68382-389_5cf85a8a-effe-4207-8b72-e91e8c4f4650
NDC68382-389
Product TypeHuman Prescription Drug
Proprietary NameMemantine Hydrochloride
Generic NameMemantine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-09-28
Marketing CategoryANDA / ANDA
Application NumberANDA090961
Labeler NameZydus Pharmaceuticals (USA) Inc.
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 Through2019-12-31

Packaging

NDC 68382-389-01

100 TABLET, FILM COATED in 1 BOTTLE (68382-389-01)
Marketing Start Date2017-09-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-389-10 [68382038910]

Memantine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090961
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-28
Marketing End Date2019-04-26

NDC 68382-389-01 [68382038901]

Memantine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090961
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-28
Marketing End Date2019-04-26

NDC 68382-389-05 [68382038905]

Memantine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090961
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-28
Marketing End Date2019-04-26

NDC 68382-389-30 [68382038930]

Memantine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090961
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-28
Marketing End Date2019-04-26

NDC 68382-389-14 [68382038914]

Memantine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090961
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-28
Marketing End Date2019-04-26

NDC 68382-389-77 [68382038977]

Memantine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090961
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-28
Marketing End Date2019-04-26

Drug Details

Active Ingredients

IngredientStrength
MEMANTINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:2086e21e-811b-45af-b9d2-86dff7e965b1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996561
  • 996571
    • UPC Code
  • 0368382388148
  • 0368382389145

    • Pharmacological Class

    • 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
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