NDC 65084-456

Pacerone

Amiodarone Hydrochloride

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

Product ID65084-456_c3eb47b7-1f64-4ed5-8f94-251c9202c254
NDC65084-456
Product TypeHuman Prescription Drug
Proprietary NamePacerone
Generic NameAmiodarone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-01-19
Marketing CategoryANDA / ANDA
Application NumberANDA075135
Labeler NameMckesson Rxpak Inc
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 65084-456-18

90 TABLET in 1 BOTTLE (65084-456-18)
Marketing Start Date2011-01-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65084-456-20 [65084045620]

Pacerone TABLET
Marketing CategoryANDA
Application NumberANDA075135
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-19
Marketing End Date2019-09-05

NDC 65084-456-18 [65084045618]

Pacerone TABLET
Marketing CategoryANDA
Application NumberANDA075135
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-19
Marketing End Date2019-09-05

Drug Details

Active Ingredients

IngredientStrength
AMIODARONE HYDROCHLORIDE200 mg/1

OpenFDA Data

SPL SET ID:a13a7632-74ea-4e2f-b791-190a4765c295
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 834346
  • 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]

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

    NDCBrand NameGeneric Name
    0245-0144PaceroneAmiodarone Hydrochloride
    0245-0145PaceroneAmiodarone Hydrochloride
    0245-0147PaceroneAmiodarone Hydrochloride
    0245-1645PaceroneAmiodarone Hydrochloride
    55154-5606PaceronePacerone
    65084-456PaceronePacerone
    67544-570PaceronePacerone
    42494-307Amiodarone HClAmiodarone Hydrochloride
    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

    Trademark Results [Pacerone]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PACERONE
    PACERONE
    75028678 2127660 Live/Registered
    UPSHER-SMITH LABORATORIES, LLC
    1995-12-06
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.