NDC 0615-8258

Amiodarone Hydrochloride

Amiodarone Hydrochloride

Amiodarone Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Amiodarone Hydrochloride.

• Product ID: 0615-8258_1bdd90a5-9f6b-45e5-8d77-c1d26dcc3802
• NDC: 0615-8258
• Product Type: Human Prescription Drug
• Proprietary Name: Amiodarone Hydrochloride
• Generic Name: Amiodarone Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-06-03
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204742
• Labeler Name: NCS HealthCare of KY, Inc dba Vangard Labs
• Substance Name: AMIODARONE HYDROCHLORIDE
• Active Ingredient Strength: 200 mg/1
• 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 0615-8258-05

15 TABLET in 1 BLISTER PACK (0615-8258-05)

• Marketing Start Date: 2019-03-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0615-8258-39 [00615825839]

Amiodarone Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA204742
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-03-05

NDC 0615-8258-05 [00615825805]

Amiodarone Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA204742
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-03-05

Drug Details

Active Ingredients

Ingredient	Strength
AMIODARONE HYDROCHLORIDE	200 mg/1

OpenFDA Data

• SPL SET ID: d42293e9-07fa-41b4-a08b-2e388f5b1e13
• Manufacturer:
  • NCS HealthCare of KY, Inc dba Vangard Labs
• 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]
• 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 Hydrochloride" or generic name "Amiodarone Hydrochloride"

NDC	Brand Name	Generic Name
0143-9875	Amiodarone Hydrochloride	Amiodarone Hydrochloride
0185-0144	Amiodarone Hydrochloride	Amiodarone Hydrochloride
0404-9815	Amiodarone Hydrochloride	Amiodarone Hydrochloride
0615-4545	Amiodarone Hydrochloride	Amiodarone Hydrochloride
0615-8213	Amiodarone hydrochloride	Amiodarone hydrochloride
0615-8258	Amiodarone Hydrochloride	Amiodarone Hydrochloride
0904-6556	Amiodarone hydrochloride	Amiodarone hydrochloride
0904-6993	Amiodarone Hydrochloride	Amiodarone Hydrochloride
16714-843	Amiodarone Hydrochloride	Amiodarone Hydrochloride
16714-844	Amiodarone Hydrochloride	Amiodarone Hydrochloride
16714-845	Amiodarone Hydrochloride	Amiodarone Hydrochloride
21695-796	Amiodarone hydrochloride	Amiodarone hydrochloride
25021-302	amiodarone hydrochloride	amiodarone hydrochloride
29300-359	Amiodarone Hydrochloride	Amiodarone Hydrochloride
42291-118	Amiodarone Hydrochloride	Amiodarone Hydrochloride
42291-139	Amiodarone Hydrochloride	Amiodarone Hydrochloride
68083-112	Amiodarone hydrochloride	Amiodarone hydrochloride
68084-371	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE
68382-227	Amiodarone hydrochloride	Amiodarone hydrochloride
70518-1231	Amiodarone Hydrochloride	Amiodarone Hydrochloride
70518-1939	Amiodarone Hydrochloride	Amiodarone Hydrochloride
70518-1571	Amiodarone hydrochloride	Amiodarone hydrochloride
71335-0881	Amiodarone Hydrochloride	Amiodarone Hydrochloride
71872-7149	Amiodarone Hydrochloride	Amiodarone Hydrochloride
71872-7000	Amiodarone Hydrochloride	Amiodarone Hydrochloride
50090-2308	Amiodarone hydrochloride	Amiodarone hydrochloride
50090-3015	Amiodarone Hydrochloride	Amiodarone Hydrochloride
50090-3496	Amiodarone Hydrochloride	Amiodarone Hydrochloride
51662-1205	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE
51672-4025	Amiodarone Hydrochloride	Amiodarone Hydrochloride
51862-240	Amiodarone Hydrochloride	Amiodarone Hydrochloride
51672-4057	Amiodarone Hydrochloride	Amiodarone Hydrochloride
51672-4056	Amiodarone Hydrochloride	Amiodarone Hydrochloride
51862-242	Amiodarone Hydrochloride	Amiodarone Hydrochloride
51672-4055	Amiodarone Hydrochloride	Amiodarone Hydrochloride
51862-241	Amiodarone Hydrochloride	Amiodarone Hydrochloride
52584-616	Amiodarone Hydrochloride	Amiodarone Hydrochloride
52584-063	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE
53808-1066	Amiodarone hydrochloride	Amiodarone hydrochloride
55150-180	Amiodarone Hydrochloride	Amiodarone Hydrochloride
55154-4996	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE
55150-182	Amiodarone Hydrochloride	Amiodarone Hydrochloride
55154-5492	Amiodarone Hydrochloride	Amiodarone Hydrochloride
55150-181	Amiodarone Hydrochloride	Amiodarone Hydrochloride
55648-780	Amiodarone Hydrochloride	Amiodarone Hydrochloride
55648-739	Amiodarone Hydrochloride	Amiodarone Hydrochloride
60505-2658	Amiodarone Hydrochloride	Amiodarone Hydrochloride
63323-616	Amiodarone Hydrochloride	Amiodarone Hydrochloride
63629-7300	Amiodarone hydrochloride	Amiodarone hydrochloride
63739-387	Amiodarone Hydrochloride	Amiodarone Hydrochloride