NDC 0245-0145

Pacerone

Amiodarone Hydrochloride

Pacerone is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Llc. The primary component is Amiodarone Hydrochloride.

Product ID0245-0145_7c5ce47c-8219-49a8-a958-e2b7a7ff68d7
NDC0245-0145
Product TypeHuman Prescription Drug
Proprietary NamePacerone
Generic NameAmiodarone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2000-06-30
Marketing CategoryANDA / ANDA
Application NumberANDA075315
Labeler NameUpsher-Smith Laboratories, LLC
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
Listing Certified Through2020-12-31

Packaging

NDC 0245-0145-01

100 BLISTER PACK in 1 CARTON (0245-0145-01) > 1 TABLET in 1 BLISTER PACK (0245-0145-89)
Marketing Start Date2000-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0245-0145-15 [00245014515]

Pacerone TABLET
Marketing CategoryANDA
Application NumberANDA075315
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-06-30
Marketing End Date2023-09-30

NDC 0245-0145-11 [00245014511]

Pacerone TABLET
Marketing CategoryANDA
Application NumberANDA075315
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-06-30
Marketing End Date2005-12-31

NDC 0245-0145-01 [00245014501]

Pacerone TABLET
Marketing CategoryANDA
Application NumberANDA075315
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-06-30

NDC 0245-0145-89 [00245014589]

Pacerone TABLET
Marketing CategoryANDA
Application NumberANDA075315
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-06-30

NDC 0245-0145-30 [00245014530]

Pacerone TABLET
Marketing CategoryANDA
Application NumberANDA075315
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-06-30
Marketing End Date2023-09-30

Drug Details

Active Ingredients

IngredientStrength
AMIODARONE HYDROCHLORIDE400 mg/1

OpenFDA Data

SPL SET ID:730039c2-0a32-4775-855d-98b2207e93e2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 834350
  • 834348

    • 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 "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
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