Amiodarone Hydrochloride

Product NDC

63739-387

11-digit product format

637390387

Labeler code

63739

Product ID

63739-387_7f532e02-8004-4596-b23f-a53b590cff98

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Amiodarone Hydrochloride

Dosage form

TABLET

Route

ORAL

Labeler

McKesson Corporation dba SKY Packaging

Application

ANDA075315

Marketing category

ANDA

Marketing start

1998-12-23

Marketing end

0000-00-00

Substance

AMIODARONE HYDROCHLORIDE

Active strength

200 mg/1

Pharmacologic 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

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record