NDC 0615-8319

Memantine

Memantine

Memantine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Memantine Hydrochloride.

Product ID0615-8319_43b61a6b-626f-417c-86ca-043e7bc0e808
NDC0615-8319
Product TypeHuman Prescription Drug
Proprietary NameMemantine
Generic NameMemantine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-07-11
Marketing CategoryANDA / ANDA
Application NumberANDA090048
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
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 0615-8319-05

15 TABLET in 1 BLISTER PACK (0615-8319-05)
Marketing Start Date2019-09-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-8319-39 [00615831939]

Memantine TABLET
Marketing CategoryANDA
Application NumberANDA090048
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-03

NDC 0615-8319-05 [00615831905]

Memantine TABLET
Marketing CategoryANDA
Application NumberANDA090048
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-03

Drug Details

Active Ingredients

IngredientStrength
MEMANTINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:5c8a168d-aef5-4ac7-b8c1-3812a8c228ab
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" or generic name "Memantine"

    NDCBrand NameGeneric Name
    0615-8100MemantineMemantine
    0615-8192MemantineMemantine
    0615-8319MemantineMemantine
    0904-6505MemantineMemantine
    0904-6506MemantineMemantine
    55111-596MemantineMemantine
    55111-597MemantineMemantine
    55154-4151MemantineMemantine
    55154-7637MemantineMemantine
    60505-6162MEMANTINEmemantine hydrochloride
    60687-173MemantineMemantine
    60687-184MemantineMemantine
    0378-1103Memantine Hydrochloridememantine
    0378-1104Memantine Hydrochloridememantine
    0378-5435Memantine Hydrochloridememantine
    0378-5436Memantine Hydrochloridememantine
    0378-5437Memantine Hydrochloridememantine
    0378-5438Memantine Hydrochloridememantine
    42291-551Memantine hydrochlorideMemantine
    42291-552Memantine hydrochlorideMemantine
    42292-005Memantine Hydrochloridememantine
    42292-006Memantine Hydrochloridememantine
    53746-169Memantine hydrochlorideMemantine
    53746-173Memantine hydrochlorideMemantine
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