NDC 42494-308

Amiodarone HCl

Amiodarone Hydrochloride

Amiodarone HCl is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Cameron Pharmaceuticals, Llc. The primary component is Amiodarone Hydrochloride.

Product ID42494-308_7cda354d-4a32-10c5-e053-2991aa0a3a03
NDC42494-308
Product TypeHuman Prescription Drug
Proprietary NameAmiodarone HCl
Generic NameAmiodarone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA077069
Labeler NameCameron Pharmaceuticals, LLC
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 Through2019-12-31

Packaging

NDC 42494-308-06

60 TABLET in 1 BOTTLE (42494-308-06)
Marketing Start Date2018-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42494-308-06 [42494030806]

Amiodarone HCl TABLET
Marketing CategoryANDA
Application NumberANDA077069
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-01

NDC 42494-308-30 [42494030830]

Amiodarone HCl TABLET
Marketing CategoryANDA
Application NumberANDA077069
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-01
Marketing End Date2018-04-12

Drug Details

Active Ingredients

IngredientStrength
AMIODARONE HYDROCHLORIDE200 mg/1

OpenFDA Data

SPL SET ID:d779a746-0bdd-49cc-b0d8-5f9a72524b8c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 835956
  • 834348
  • 833528
    • UPC Code
  • 0342494309031
  • 0342494307037
  • 0342494308065

    • 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 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
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