Pacerone

Product NDC
65084-456
11-digit product format
650840456
Labeler code
65084
Product ID
65084-456_c3eb47b7-1f64-4ed5-8f94-251c9202c254
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Mckesson Rxpak Inc
Application
ANDA075135
Marketing category
ANDA
Marketing start
2011-01-19
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
2019-12-31
Current FDA listing
Historical FDA.report record