NDC 21695-564

Amantadine HCl

Amantadine Hydrochloride

Amantadine HCl is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp.. The primary component is Amantadine Hydrochloride.

Product ID21695-564_c74c9424-278d-4a52-8866-db66f6c3ac67
NDC21695-564
Product TypeHuman Prescription Drug
Proprietary NameAmantadine HCl
Generic NameAmantadine Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2008-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA078720
Labeler NameRebel Distributors Corp.
Substance NameAMANTADINE HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesInfluenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-564-10

10 CAPSULE in 1 BOTTLE (21695-564-10)
Marketing Start Date2008-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-564-10 [21695056410]

Amantadine HCl CAPSULE
Marketing CategoryANDA
Application NumberANDA078720
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-01
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
AMANTADINE HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:c74c9424-278d-4a52-8866-db66f6c3ac67
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 849389
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    10888-5006Amantadine HClAMANTADINE HYDROCHLORIDE
    21695-564Amantadine HClAmantadine hydrochloride
    68788-9530Amantadine HClAmantadine HCl
    69387-100Amantadine HClAmantadine HCl
    69452-142Amantadine HClAmantadine HCl
    71335-0279Amantadine HClAmantadine HCl
    42291-125Amantadine HClAmantadine HCl
    50268-069Amantadine HClAmantadine HCl
    53808-0933Amantadine HClAmantadine HCl
    63629-2681Amantadine HClAmantadine HCl
    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

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