NDC 0378-1104

Memantine Hydrochloride

Memantine

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

Product ID0378-1104_4b207674-ac13-44ea-a422-834a9e86d7f6
NDC0378-1104
Product TypeHuman Prescription Drug
Proprietary NameMemantine Hydrochloride
Generic NameMemantine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-07-11
Marketing End Date2019-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA079225
Labeler NameMylan Pharmaceuticals Inc.
Substance NameMEMANTINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesNMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC Exclude FlagN

Packaging

NDC 0378-1104-91

60 TABLET in 1 BOTTLE, PLASTIC (0378-1104-91)
Marketing Start Date2015-07-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-1104-05 [00378110405]

Memantine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA079225
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-07-11
Marketing End Date2019-05-03

NDC 0378-1104-91 [00378110491]

Memantine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA079225
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-07-11
Marketing End Date2019-10-31

Drug Details

Active Ingredients

IngredientStrength
MEMANTINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:be032f1e-c123-45a0-a345-a56be6fa43a6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996561
  • 996571

    • Pharmacological Class

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