NDC 51662-1363

AMIODARONE HCI

Amiodarone Hci

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: 51662-1363_993b2557-6775-bb7a-e053-2995a90a0503
• NDC: 51662-1363
• Product Type: Human Prescription Drug
• Proprietary Name: AMIODARONE HCI
• Generic Name: Amiodarone Hci
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-12-08
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075761
• Labeler Name: HF Acquisition Co LLC, DBA HealthFirst
• Substance Name: AMIODARONE HYDROCHLORIDE
• Active Ingredient Strength: 50 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: 2020-12-31

Packaging

NDC 51662-1363-1

3 mL in 1 VIAL, SINGLE-DOSE (51662-1363-1)

• Marketing Start Date: 2019-12-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51662-1363-1 [51662136301]

AMIODARONE HCI INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA075761
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-12-08

Drug Details

Active Ingredients

Ingredient	Strength
AMIODARONE HYDROCHLORIDE	50 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]