NDC 65841-631

Amiodarone hydrochloride

Amiodarone Hydrochloride

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

Product ID65841-631_44ec062e-e0b0-4e88-84b8-6d965b7609a6
NDC65841-631
Product TypeHuman Prescription Drug
Proprietary NameAmiodarone hydrochloride
Generic NameAmiodarone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-08-10
Marketing CategoryANDA / ANDA
Application NumberANDA079029
Labeler NameCadila Healthcare Limited
Substance NameAMIODARONE HYDROCHLORIDE
Active Ingredient Strength200 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 Through2021-12-31

Packaging

NDC 65841-631-05

500 TABLET in 1 BOTTLE (65841-631-05)
Marketing Start Date2009-08-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65841-631-10 [65841063110]

Amiodarone hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA079029
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-08-10

NDC 65841-631-05 [65841063105]

Amiodarone hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA079029
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-08-10

NDC 65841-631-30 [65841063130]

Amiodarone hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA079029
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-08-10

NDC 65841-631-06 [65841063106]

Amiodarone hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA079029
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-08-10

NDC 65841-631-14 [65841063114]

Amiodarone hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA079029
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-08-10

Drug Details

Active Ingredients

IngredientStrength
AMIODARONE HYDROCHLORIDE200 mg/1

OpenFDA Data

SPL SET ID:3e8db251-e3c5-4fba-be9a-6044a92f0beb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 833528
    • UPC Code
  • 0365841631050

    • 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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