AMIODARONE HYDROCHLORIDE

Product NDC

68084-371

11-digit product format

680840371

Labeler code

68084

Product ID

68084-371_a6286918-2fde-be5e-e053-2a95a90a6bb9

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

AMIODARONE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Labeler

American Health Packaging

Application

ANDA079029

Marketing category

ANDA

Marketing start

2009-09-10

Marketing end

2020-10-31

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

0000-00-00

Current FDA listing

Historical FDA.report record