NDC 0527-1221

Memantine Hydrochloride

Memantine Hydrochloride

Memantine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Memantine Hydrochloride.

Product ID0527-1221_3e80b956-64be-4b5c-8ed8-213713aa18af
NDC0527-1221
Product TypeHuman Prescription Drug
Proprietary NameMemantine Hydrochloride
Generic NameMemantine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-11-10
Marketing CategoryANDA / ANDA
Application NumberANDA207236
Labeler NameLannett Company, Inc.
Substance NameMEMANTINE HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesNMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0527-1221-05

500 TABLET in 1 BOTTLE, PLASTIC (0527-1221-05)
Marketing Start Date2016-11-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0527-1221-05 [00527122105]

Memantine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA207236
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-10

NDC 0527-1221-06 [00527122106]

Memantine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA207236
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-10

NDC 0527-1221-10 [00527122110]

Memantine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA207236
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-10

Drug Details

Active Ingredients

IngredientStrength
MEMANTINE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:88b7952b-b58a-495e-aa19-d3392d2e2759
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996561
  • 996571
  • UPC Code
  • 0305271222060
  • 0305271221063
  • 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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