NDC 0904-6506

Memantine

Memantine

Memantine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Memantine Hydrochloride.

Product ID0904-6506_067be3c1-9cd3-409c-b9a9-7381268ab867
NDC0904-6506
Product TypeHuman Prescription Drug
Proprietary NameMemantine
Generic NameMemantine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-07-20
Marketing CategoryANDA / ANDA
Application NumberANDA090048
Labeler NameMajor Pharmaceuticals
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 0904-6506-06

50 BLISTER PACK in 1 CARTON (0904-6506-06) > 1 TABLET in 1 BLISTER PACK
Marketing Start Date2015-07-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6506-61 [00904650661]

Memantine TABLET
Marketing CategoryANDA
Application NumberANDA090048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-07-20

NDC 0904-6506-06 [00904650606]

Memantine TABLET
Marketing CategoryANDA
Application NumberANDA090048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-07-20

Drug Details

Active Ingredients

IngredientStrength
MEMANTINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:d0a5e0fc-04e3-417d-bef3-9b309ff71597
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996561
  • 996571

    • Pharmacological Class

    • 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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