NDC 43066-360

Nexterone

Amiodarone Hydrochloride

Nexterone is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Amiodarone Hydrochloride.

Product ID43066-360_26bdbf94-9fc5-4b44-8d56-f2096e95a402
NDC43066-360
Product TypeHuman Prescription Drug
Proprietary NameNexterone
Generic NameAmiodarone Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2010-11-16
Marketing CategoryNDA / NDA
Application NumberNDA022325
Labeler NameBaxter Healthcare Corporation
Substance NameAMIODARONE HYDROCHLORIDE
Active Ingredient Strength2 mg/mL
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 Through2022-12-31

Packaging

NDC 43066-360-20

200 mL in 1 BAG (43066-360-20)
Marketing Start Date2010-11-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43066-360-20 [43066036020]

Nexterone INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA022325
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-11-16

Drug Details

Active Ingredients

IngredientStrength
AMIODARONE HYDROCHLORIDE1.8 mg/mL

OpenFDA Data

SPL SET ID:e9108958-b8d7-4fba-87c3-9a32990de551
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1046408
  • 1046410
  • 1046406
  • 849876

    • 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 "Nexterone" or generic name "Amiodarone Hydrochloride"

    NDCBrand NameGeneric Name
    43066-360NexteroneNexterone
    43066-150NexteroneNexterone
    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
    0245-0144PaceroneAmiodarone Hydrochloride
    0245-0145PaceroneAmiodarone Hydrochloride
    0245-0147PaceroneAmiodarone Hydrochloride
    0245-1645PaceroneAmiodarone Hydrochloride

    Trademark Results [Nexterone]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NEXTERONE
    NEXTERONE
    78910301 3438253 Live/Registered
    BAXTER INTERNATIONAL, INC.
    2006-06-16
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.