NDC 42543-497

Amantadine Hydrochloride

Amantadine Hydrochloride

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

Product ID42543-497_6ac9faed-6ab0-4563-9d5b-d7ed817bf017
NDC42543-497
Product TypeHuman Prescription Drug
Proprietary NameAmantadine Hydrochloride
Generic NameAmantadine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-06-21
Marketing CategoryANDA / ANDA
Application NumberANDA209035
Labeler NameVensun Pharmaceuticals, Inc
Substance NameAMANTADINE HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesInfluenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42543-497-01

100 TABLET in 1 BOTTLE (42543-497-01)
Marketing Start Date2017-08-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42543-497-05 [42543049705]

Amantadine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA209035
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-08-08

NDC 42543-497-01 [42543049701]

Amantadine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA209035
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-08-04

Drug Details

Active Ingredients

IngredientStrength
AMANTADINE HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:9a99bb98-82a4-4b9e-9216-554dade72a3c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 849395

    • Pharmacological Class

    • Influenza A M2 Protein Inhibitor [EPC]
    • M2 Protein Inhibitors [MoA]

    Medicade Reported Pricing

    42543049705 AMANTADINE 100 MG TABLET

    Pricing Unit: EA | Drug Type:

    42543049701 AMANTADINE 100 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    0121-0646AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE
    0527-1704Amantadine HydrochlorideAmantadine Hydrochloride
    0527-1868Amantadine HydrochlorideAmantadine Hydrochloride
    0591-4920Amantadine HydrochlorideAmantadine Hydrochloride
    0591-4930Amantadine HydrochlorideAmantadine Hydrochloride
    0615-0326Amantadine HydrochlorideAmantadine Hydrochloride
    0615-8263Amantadine HydrochlorideAmantadine Hydrochloride
    0781-2048Amantadine HydrochlorideAmantadine Hydrochloride
    0781-2320Amantadine HydrochlorideAmantadine Hydrochloride
    0832-0111Amantadine Hydrochlorideamantadine hydrochloride
    0832-1015Amantadine Hydrochlorideamantadine hydrochloride
    0832-2012Amantadine HydrochlorideAmantadine Hydrochloride
    0904-6630amantadine hydrochlorideamantadine hydrochloride
    0904-7042Amantadine HydrochlorideAmantadine Hydrochloride
    10135-692Amantadine HydrochlorideAmantadine Hydrochloride
    10135-693Amantadine HydrochlorideAmantadine Hydrochloride
    16571-834Amantadine HydrochlorideAmantadine Hydrochloride
    17856-0093Amantadine HydrochlorideAMANTADINE HYDROCHLORIDE
    17856-0646AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE
    23155-362Amantadine HydrochlorideAmantadine Hydrochloride
    24689-105AMANTADINE HYDROCHLORIDEamantadine hydrochloride
    24689-112AMANTADINE HYDROCHLORIDEamantadine hydrochloride
    33261-773Amantadine HydrochlorideAmantadine Hydrochloride
    68084-611Amantadine HydrochlorideAmantadine Hydrochloride
    68151-0910AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE
    68151-2991Amantadine HydrochlorideAmantadine Hydrochloride
    68382-512amantadine hydrochlorideamantadine hydrochloride
    68788-7088Amantadine HydrochlorideAmantadine Hydrochloride
    68788-6975amantadine hydrochlorideamantadine hydrochloride
    68996-101AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE
    69097-926Amantadine hydrochlorideAmantadine hydrochloride
    68996-102AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE
    69097-925amantadine hydrochlorideamantadine hydrochloride
    69844-026Amantadine hydrochlorideAmantadine hydrochloride
    69844-027amantadine hydrochlorideamantadine hydrochloride
    71335-0469amantadine hydrochlorideamantadine hydrochloride
    71205-223Amantadine HydrochlorideAmantadine Hydrochloride
    42543-493Amantadine HydrochlorideAmantadine Hydrochloride
    42543-497Amantadine HydrochlorideAmantadine Hydrochloride
    43353-947Amantadine HydrochlorideAmantadine Hydrochloride
    46672-606amantadine hydrochlorideamantadine hydrochloride
    50090-0020Amantadine HydrochlorideAmantadine Hydrochloride
    50436-0646AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE
    50383-807Amantadine HydrochlorideAmantadine Hydrochloride
    51079-247Amantadine HydrochlorideAmantadine Hydrochloride
    53002-3750Amantadine HydrochlorideAmantadine Hydrochloride
    55154-9444AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE
    55289-012Amantadine HydrochlorideAmantadine Hydrochloride
    59746-699amantadine hydrochlorideamantadine hydrochloride
    60432-093Amantadine HydrochlorideAmantadine Hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.