NDC 52533-101

Amiodarone HCl

Amiodarone Hcl

Amiodarone HCl is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Cantrell Drug Company. The primary component is Amiodarone Hydrochloride.

• Product ID: 52533-101_10eea951-d568-45fe-8ab3-1450fda1a64c
• NDC: 52533-101
• Product Type: Human Prescription Drug
• Proprietary Name: Amiodarone HCl
• Generic Name: Amiodarone Hcl
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2011-08-01
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Cantrell Drug Company
• 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: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 52533-101-59

500 mL in 1 BAG (52533-101-59)

• Marketing Start Date: 2013-10-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52533-101-59 [52533010159]

Amiodarone HCl INJECTION, SOLUTION

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-10-18
• Inactivation Date: 2019-11-27

NDC 52533-101-58 [52533010158]

Amiodarone HCl INJECTION, SOLUTION

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-08-01
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
AMIODARONE HYDROCHLORIDE	1.8 mg/mL

OpenFDA Data

• SPL SET ID: 794f9f8e-44fb-4087-b76f-a7cc826f9523
• Manufacturer:
  • Cantrell Drug Company
• UNII:
  • 976728SY6Z

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 "Amiodarone HCl" or generic name "Amiodarone Hcl"

NDC	Brand Name	Generic Name
42494-307	Amiodarone HCl	Amiodarone Hydrochloride
42494-308	Amiodarone HCl	Amiodarone Hydrochloride
42494-309	Amiodarone HCl	Amiodarone Hydrochloride
51862-154	Amiodarone HCl	Amiodarone Hydrochloride
51862-155	Amiodarone HCl	Amiodarone Hydrochloride
51862-156	Amiodarone HCl	Amiodarone Hydrochloride
52533-101	Amiodarone HCl	Amiodarone HCl
63629-2001	Amiodarone HCl	Amiodarone Hydrochloride
63629-2076	Amiodarone HCl	Amiodarone Hydrochloride
63629-9294	Amiodarone HCl	Amiodarone Hydrochloride