NDC 17856-0093

Amantadine Hydrochloride

Amantadine Hydrochloride

Amantadine Hydrochloride is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Atlantic Biologicals Corps. The primary component is Amantadine Hydrochloride.

Product ID17856-0093_99d67846-14c5-4203-ba32-ffec4f6a8fab
NDC17856-0093
Product TypeHuman Prescription Drug
Proprietary NameAmantadine Hydrochloride
Generic NameAmantadine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date1998-12-24
Marketing CategoryANDA / ANDA
Application NumberANDA075060
Labeler NameAtlantic Biologicals Corps
Substance NameAMANTADINE HYDROCHLORIDE
Active Ingredient Strength50 mg/5mL
Pharm ClassesInfluenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 17856-0093-1

72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0093-1) > 10 mL in 1 CUP, UNIT-DOSE
Marketing Start Date2020-05-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0093-1 [17856009301]

Amantadine Hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA075060
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-20
Inactivation Date2020-01-31
Reactivation Date2020-05-20

NDC 17856-0093-3 [17856009303]

Amantadine Hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA075060
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-20
Inactivation Date2020-01-31
Reactivation Date2020-05-20

Drug Details

Active Ingredients

IngredientStrength
AMANTADINE HYDROCHLORIDE50 mg/5mL

OpenFDA Data

SPL SET ID:97d6bd4a-31ca-4b33-8353-a536835ef1e1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 849385
  • Pharmacological Class

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

    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.