NDC 0378-5438

Memantine Hydrochloride

Memantine

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

Product ID0378-5438_642189b4-b4ad-424a-9c89-4dcbde5b2773
NDC0378-5438
Product TypeHuman Prescription Drug
Proprietary NameMemantine Hydrochloride
Generic NameMemantine
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-02-21
Marketing CategoryANDA / ANDA
Application NumberANDA206032
Labeler NameMylan Pharmaceuticals Inc.
Substance NameMEMANTINE HYDROCHLORIDE
Active Ingredient Strength28 mg/1
Pharm ClassesNMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0378-5438-77

90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-5438-77)
Marketing Start Date2018-02-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-5438-93 [00378543893]

Memantine Hydrochloride CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206032
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-21

NDC 0378-5438-77 [00378543877]

Memantine Hydrochloride CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA206032
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-21

Drug Details

Active Ingredients

IngredientStrength
MEMANTINE HYDROCHLORIDE28 mg/1

OpenFDA Data

SPL SET ID:19c74245-9681-4623-8166-cd29bb4957b9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996594
  • 996609
  • 996615
  • 996603
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Memantine Hydrochloride" or generic name "Memantine"

    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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