NDC 51862-156

Amiodarone HCl

Amiodarone Hydrochloride

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

Product ID51862-156_02f504e6-835e-44c8-828e-9352e78c8e75
NDC51862-156
Product TypeHuman Prescription Drug
Proprietary NameAmiodarone HCl
Generic NameAmiodarone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-01-01
Marketing End Date2019-12-31
Marketing CategoryANDA / ANDA
Application NumberANDA077069
Labeler NameMayne Pharma Inc.
Substance NameAMIODARONE HYDROCHLORIDE
Active Ingredient Strength400 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

Packaging

NDC 51862-156-30

30 TABLET in 1 BOTTLE (51862-156-30)
Marketing Start Date2013-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51862-156-30 [51862015630]

Amiodarone HCl TABLET
Marketing CategoryANDA
Application NumberANDA077069
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-01-01
Marketing End Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
AMIODARONE HYDROCHLORIDE400 mg/1

OpenFDA Data

SPL SET ID:08641e51-abca-4c1c-ba19-d24435332018
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 835956
  • 834348
  • 833528

    • 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]

    Medicade Reported Pricing

    51862015630 AMIODARONE HCL 400 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Amiodarone HCl" or generic name "Amiodarone Hydrochloride"

    NDCBrand NameGeneric Name
    42494-307Amiodarone HClAmiodarone Hydrochloride
    42494-308Amiodarone HClAmiodarone HCl
    42494-309Amiodarone HClAmiodarone HCl
    51862-154Amiodarone HClAmiodarone HCl
    51862-156Amiodarone HClAmiodarone HCl
    51862-155Amiodarone HClAmiodarone HCl
    52533-101Amiodarone HClAmiodarone HCl
    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
    0245-0144PaceroneAmiodarone Hydrochloride
    0245-0145PaceroneAmiodarone Hydrochloride
    0245-0147PaceroneAmiodarone Hydrochloride
    0245-1645PaceroneAmiodarone Hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.