Amiodarone HCl

Product NDC

51862-156

11-digit product format

518620156

Labeler code

51862

Product ID

51862-156_02f504e6-835e-44c8-828e-9352e78c8e75

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Amiodarone Hydrochloride

Dosage form

TABLET

Route

ORAL

Labeler

Mayne Pharma Inc.

Application

ANDA077069

Marketing category

ANDA

Marketing start

2013-01-01

Marketing end

2019-12-31

Substance

AMIODARONE HYDROCHLORIDE

Active strength

400 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

0000-00-00

Current FDA listing

Historical FDA.report record