NDC 0456-3414

Namenda XR

Memantine Hydrochloride

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

Product ID0456-3414_3fae1fd7-ac36-4564-9de9-84533cea4636
NDC0456-3414
Product TypeHuman Prescription Drug
Proprietary NameNamenda XR
Generic NameMemantine Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2011-10-31
Marketing CategoryNDA / NDA
Application NumberNDA022525
Labeler NameAllergan, Inc.
Substance NameMEMANTINE HYDROCHLORIDE
Active Ingredient Strength14 mg/1
Pharm ClassesNMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0456-3414-33

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0456-3414-33)
Marketing Start Date2011-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0456-3414-63 [00456341463]

Namenda XR CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022525
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-10-31
Marketing End Date2016-09-06

NDC 0456-3414-90 [00456341490]

Namenda XR CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022525
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-10-31

NDC 0456-3414-11 [00456341411]

Namenda XR CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022525
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-10-31

NDC 0456-3414-33 [00456341433]

Namenda XR CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022525
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-10-31

Drug Details

Active Ingredients

IngredientStrength
MEMANTINE HYDROCHLORIDE14 mg/1

OpenFDA Data

SPL SET ID:710f523f-0158-4639-8ce7-57598247d48c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996594
  • 996624
  • 996603
  • 996605
  • 996633
  • 996617
  • 996609
  • 996615
  • 996611
  • 996597
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    68151-5755Namenda XRNamenda XR
    68151-5817Namenda XRNamenda XR
    68151-5829Namenda XRNamenda XR
    0121-0850Memantine HydrochlorideMemantine Hydrochloride
    0527-1221Memantine HydrochlorideMemantine Hydrochloride
    0527-1222Memantine HydrochlorideMemantine Hydrochloride
    0527-1943Memantine HydrochlorideMemantine Hydrochloride
    0591-3011memantine hydrochloridememantine hydrochloride
    0591-3870memantine hydrochloridememantine hydrochloride
    0456-3200NamendaMemantine Hydrochloride
    0456-3205Namendamemantine hydrochloride
    0456-3210Namendamemantine hydrochloride
    0456-3400Namendamemantine hydrochloride
    0456-3407Namendamemantine hydrochloride
    0456-3414Namendamemantine hydrochloride
    0456-3421Namendamemantine hydrochloride
    0456-3428Namendamemantine hydrochloride

    Trademark Results [Namenda]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NAMENDA
    NAMENDA
    78093238 2843824 Live/Registered
    MERZ PHARMA GMBH & CO. KGAA
    2001-11-14

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