NDC 55648-739

Amiodarone Hydrochloride

Amiodarone Hydrochloride

Amiodarone Hydrochloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Wockhardt Limited. The primary component is Amiodarone Hydrochloride.

Product ID55648-739_e11649f1-cacd-4246-ba5c-c45407d16c93
NDC55648-739
Product TypeHuman Prescription Drug
Proprietary NameAmiodarone Hydrochloride
Generic NameAmiodarone Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2008-10-30
Marketing CategoryANDA / ANDA
Application NumberANDA077610
Labeler NameWockhardt Limited
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 Through2019-12-31

Packaging

NDC 55648-739-04

5 VIAL in 1 CARTON (55648-739-04) > 3 mL in 1 VIAL
Marketing Start Date2008-10-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55648-739-02 [55648073902]

Amiodarone Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA077610
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-30
Inactivation Date2020-01-31

NDC 55648-739-01 [55648073901]

Amiodarone Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA077610
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-30
Inactivation Date2020-01-31

NDC 55648-739-04 [55648073904]

Amiodarone Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA077610
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-30
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
AMIODARONE HYDROCHLORIDE50 mg/mL

OpenFDA Data

SPL SET ID:b0eb6c22-7553-4e3f-a06d-20a186ced99a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 833532
  • 1663224
    • UPC Code
  • 0364679739013
  • 0364679739020

    • 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]

    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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