Amiodarone hydrochloride

Product NDC
0904-6556
11-digit product format
009046556
Labeler code
0904
Product ID
0904-6556_ccb4c59e-36fb-4b04-a7e6-fdf749a18e6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA079029
Marketing category
ANDA
Marketing start
2009-08-10
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6556-6100904655661100 BLISTER PACK in 1 CARTON (0904-6556-61) > 1 TABLET in 1 BLISTER PACK100 blister pack2009-08-100000-00-00NoNoCurrent