Amiodarone Hydrochloride

Product NDC

42291-139

11-digit product format

422910139

Labeler code

42291

Product ID

42291-139_62d4fd56-7853-bcc5-e053-2a91aa0aca75

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Amiodarone Hydrochloride

Dosage form

TABLET

Route

ORAL

Labeler

AvKARE, Inc.

Application

ANDA076362

Marketing category

ANDA

Marketing start

2016-03-18

Marketing end

0000-00-00

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

2019-12-31

Current FDA listing

Historical FDA.report record