NDC 52584-063

AMIODARONE HYDROCHLORIDE

Amiodarone Hydrochloride

AMIODARONE HYDROCHLORIDE is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables And Vaccines, Inc.. The primary component is Amiodarone Hydrochloride.

Product ID52584-063_519397a4-86a9-4532-bfa4-07ed8396d302
NDC52584-063
Product TypeHuman Prescription Drug
Proprietary NameAMIODARONE HYDROCHLORIDE
Generic NameAmiodarone Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-06-11
Marketing CategoryANDA / ANDA
Application NumberANDA077234
Labeler NameGeneral Injectables and Vaccines, Inc.
Substance NameAMIODARONE HYDROCHLORIDE
Active Ingredient Strength50 mg/mL
Pharm ClassesCytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52584-063-01

1 VIAL, SINGLE-DOSE in 1 BAG (52584-063-01) > 3 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-06-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-063-01 [52584006301]

AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA077234
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-11

Drug Details

Active Ingredients

IngredientStrength
AMIODARONE HYDROCHLORIDE50 mg/mL

OpenFDA Data

SPL SET ID:f7cba2ab-7c15-4d8e-b5d4-db24560d02b3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1663224

    • Pharmacological Class

    • Cytochrome P450 2C9 Inhibitors [MoA]
    • Cytochrome P450 2D6 Inhibitors [MoA]
    • Antiarrhythmic [EPC]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]
    • Cytochrome P450 1A2 Inhibitors [MoA]
    • Cytochrome P450 2C9 Inhibitors [MoA]
    • Cytochrome P450 2D6 Inhibitors [MoA]
    • Antiarrhythmic [EPC]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]
    • Cytochrome P450 1A2 Inhibitors [MoA]

    NDC Crossover Matching brand name "AMIODARONE HYDROCHLORIDE" or generic name "Amiodarone Hydrochloride"

    NDCBrand NameGeneric Name
    0143-9875Amiodarone HydrochlorideAmiodarone Hydrochloride
    0185-0144Amiodarone HydrochlorideAmiodarone Hydrochloride
    0404-9815Amiodarone HydrochlorideAmiodarone Hydrochloride
    0615-4545Amiodarone HydrochlorideAmiodarone Hydrochloride
    0615-8213Amiodarone hydrochlorideAmiodarone hydrochloride
    0615-8258Amiodarone HydrochlorideAmiodarone Hydrochloride
    0904-6556Amiodarone hydrochlorideAmiodarone hydrochloride
    0904-6993Amiodarone HydrochlorideAmiodarone Hydrochloride
    16714-843Amiodarone HydrochlorideAmiodarone Hydrochloride
    16714-844Amiodarone HydrochlorideAmiodarone Hydrochloride
    16714-845Amiodarone HydrochlorideAmiodarone Hydrochloride
    21695-796Amiodarone hydrochlorideAmiodarone hydrochloride
    25021-302amiodarone hydrochlorideamiodarone hydrochloride
    29300-359Amiodarone HydrochlorideAmiodarone Hydrochloride
    42291-118Amiodarone HydrochlorideAmiodarone Hydrochloride
    42291-139Amiodarone HydrochlorideAmiodarone Hydrochloride
    68083-112Amiodarone hydrochlorideAmiodarone hydrochloride
    68084-371AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE
    68382-227Amiodarone hydrochlorideAmiodarone hydrochloride
    70518-1231Amiodarone HydrochlorideAmiodarone Hydrochloride
    70518-1939Amiodarone HydrochlorideAmiodarone Hydrochloride
    70518-1571Amiodarone hydrochlorideAmiodarone hydrochloride
    71335-0881Amiodarone HydrochlorideAmiodarone Hydrochloride
    71872-7149Amiodarone HydrochlorideAmiodarone Hydrochloride
    71872-7000Amiodarone HydrochlorideAmiodarone Hydrochloride
    50090-2308Amiodarone hydrochlorideAmiodarone hydrochloride
    50090-3015Amiodarone HydrochlorideAmiodarone Hydrochloride
    50090-3496Amiodarone HydrochlorideAmiodarone Hydrochloride
    51662-1205AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE
    51672-4025Amiodarone HydrochlorideAmiodarone Hydrochloride
    51862-240Amiodarone HydrochlorideAmiodarone Hydrochloride
    51672-4057Amiodarone HydrochlorideAmiodarone Hydrochloride
    51672-4056Amiodarone HydrochlorideAmiodarone Hydrochloride
    51862-242Amiodarone HydrochlorideAmiodarone Hydrochloride
    51672-4055Amiodarone HydrochlorideAmiodarone Hydrochloride
    51862-241Amiodarone HydrochlorideAmiodarone Hydrochloride
    52584-616Amiodarone HydrochlorideAmiodarone Hydrochloride
    52584-063AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE
    53808-1066Amiodarone hydrochlorideAmiodarone hydrochloride
    55150-180Amiodarone HydrochlorideAmiodarone Hydrochloride
    55154-4996AMIODARONE HYDROCHLORIDEAMIODARONE HYDROCHLORIDE
    55150-182Amiodarone HydrochlorideAmiodarone Hydrochloride
    55154-5492Amiodarone HydrochlorideAmiodarone Hydrochloride
    55150-181Amiodarone HydrochlorideAmiodarone Hydrochloride
    55648-780Amiodarone HydrochlorideAmiodarone Hydrochloride
    55648-739Amiodarone HydrochlorideAmiodarone Hydrochloride
    60505-2658Amiodarone HydrochlorideAmiodarone Hydrochloride
    63323-616Amiodarone HydrochlorideAmiodarone Hydrochloride
    63629-7300Amiodarone hydrochlorideAmiodarone hydrochloride
    63739-387Amiodarone HydrochlorideAmiodarone Hydrochloride
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