NDC 55289-012

Amantadine Hydrochloride

Amantadine Hydrochloride

Amantadine Hydrochloride is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Amantadine Hydrochloride.

Product ID55289-012_7bad8ad7-3a13-4a5b-e053-2991aa0aee05
NDC55289-012
Product TypeHuman Prescription Drug
Proprietary NameAmantadine Hydrochloride
Generic NameAmantadine Hydrochloride
Dosage FormCapsule, Gelatin Coated
Route of AdministrationORAL
Marketing Start Date2011-09-15
Marketing CategoryANDA / ANDA
Application NumberANDA070589
Labeler NamePD-Rx 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 55289-012-20

20 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (55289-012-20)
Marketing Start Date2011-11-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55289-012-10 [55289001210]

Amantadine Hydrochloride CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA070589
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-11-21
Marketing End Date2019-09-11

NDC 55289-012-20 [55289001220]

Amantadine Hydrochloride CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA070589
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-11-21
Marketing End Date2019-09-11

NDC 55289-012-14 [55289001214]

Amantadine Hydrochloride CAPSULE, GELATIN COATED
Marketing CategoryANDA
Application NumberANDA070589
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-11-21
Marketing End Date2019-09-11

Drug Details

Active Ingredients

IngredientStrength
AMANTADINE HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:944ab74b-2657-4821-9f2a-e695b5f24d97
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 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
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