NDC 50268-097

Amiodarone Hydrochloride

Amiodarone Hydrochloride

Amiodarone Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Avpak. The primary component is Amiodarone Hydrochloride.

Product ID50268-097_924c9359-ebc5-62a7-e053-2a95a90a4327
NDC50268-097
Product TypeHuman Prescription Drug
Proprietary NameAmiodarone Hydrochloride
Generic NameAmiodarone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-09-11
Marketing CategoryANDA / ANDA
Application NumberANDA075389
Labeler NameAvPAK
Substance NameAMIODARONE HYDROCHLORIDE
Active Ingredient Strength100 mg/1
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 50268-097-15

50 BLISTER PACK in 1 BOX (50268-097-15) > 1 TABLET in 1 BLISTER PACK (50268-097-11)
Marketing Start Date2019-09-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50268-097-11 [50268009711]

Amiodarone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA075389
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-11

NDC 50268-097-15 [50268009715]

Amiodarone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA075389
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-11

Drug Details

Active Ingredients

IngredientStrength
AMIODARONE HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:924c9359-ebc4-62a7-e053-2a95a90a4327
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 835956
  • 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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