Amiodarone hydrochloride

Product NDC
50090-2308
11-digit product format
500902308
Labeler code
50090
Product ID
50090-2308_ba0edde1-80de-45f1-91b8-94c8f2598b6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
2019-12-31
Current FDA listing
Historical FDA.report record