NDC 63629-5291

Namenda

Memantine Hydrochloride

Namenda is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Memantine Hydrochloride.

Product ID63629-5291_ae4d77ae-cacb-4ce8-8c2e-8835272fb232
NDC63629-5291
Product TypeHuman Prescription Drug
Proprietary NameNamenda
Generic NameMemantine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2003-10-16
Marketing CategoryNDA / NDA
Application NumberNDA021487
Labeler NameBryant Ranch Prepack
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 Through2021-12-31

Packaging

NDC 63629-5291-1

30 TABLET in 1 BOTTLE (63629-5291-1)
Marketing Start Date2014-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-5291-2 [63629529102]

Namenda TABLET
Marketing CategoryNDA
Application NumberNDA021487
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-04-01
Inactivation Date2020-01-31

NDC 63629-5291-1 [63629529101]

Namenda TABLET
Marketing CategoryNDA
Application NumberNDA021487
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-04-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
MEMANTINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:eb9f9d29-161a-4ffd-a3be-9eccc6e50644
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996561
  • 996563
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0456-3200NamendaMemantine Hydrochloride
    0456-3205Namendamemantine hydrochloride
    0456-3210Namendamemantine hydrochloride
    0456-3400Namendamemantine hydrochloride
    0456-3407Namendamemantine hydrochloride
    0456-3414Namendamemantine hydrochloride
    0456-3421Namendamemantine hydrochloride
    0456-3428Namendamemantine hydrochloride
    21695-169NamendaNamenda
    21695-232NamendaNamenda
    55289-937NamendaNamenda
    55154-4617NamendaNamenda
    63629-3383NamendaNamenda
    63629-5291NamendaNamenda
    67046-489NamendaNamenda
    0121-0850Memantine HydrochlorideMemantine Hydrochloride
    0527-1221Memantine HydrochlorideMemantine Hydrochloride
    0527-1222Memantine HydrochlorideMemantine Hydrochloride
    0527-1943Memantine HydrochlorideMemantine Hydrochloride
    0591-3011memantine hydrochloridememantine hydrochloride
    0591-3870memantine hydrochloridememantine 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.