NDC 51662-1480

NEXTERONE (AMIODARONE HCI)

Nexterone (amiodarone Hci)

NEXTERONE (AMIODARONE HCI) is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hf Acquisition Co Llc, Dba Healthfirst. The primary component is Amiodarone Hydrochloride.

• Product ID: 51662-1480_9d4d66f7-fa15-e832-e053-2a95a90a8b62
• NDC: 51662-1480
• Product Type: Human Prescription Drug
• Proprietary Name: NEXTERONE (AMIODARONE HCI)
• Generic Name: Nexterone (amiodarone Hci)
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2020-01-29
• Marketing Category: NDA / NDA
• Application Number: NDA022325
• Labeler Name: HF Acquisition Co LLC, DBA HealthFirst
• Substance Name: AMIODARONE HYDROCHLORIDE
• Active Ingredient Strength: 2 mg/mL
• Pharm Classes: 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 Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 51662-1480-1

1 BAG in 1 CARTON (51662-1480-1) > 100 mL in 1 BAG

• Marketing Start Date: 2020-01-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51662-1480-1 [51662148001]

NEXTERONE (AMIODARONE HCI) INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA022325
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-01-29

Drug Details

Active Ingredients

Ingredient	Strength
AMIODARONE HYDROCHLORIDE	1.5 mg/mL

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 (AMIODARONE HCI)" or generic name "Nexterone (amiodarone Hci)"

NDC	Brand Name	Generic Name
51662-1480	NEXTERONE (AMIODARONE HCI)	NEXTERONE (AMIODARONE HCI)
51662-1481	NEXTERONE (AMIODARONE HCI)	NEXTERONE (AMIODARONE HCI)