Amiodarone HCl

Product NDC
42494-308
11-digit product format
424940308
Labeler code
42494
Product ID
42494-308_f0e7c97f-7697-ed89-e053-2a95a90a560b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Cameron Pharmaceuticals, LLC
Application
ANDA077069
Marketing category
ANDA
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
AMIODARONE HYDROCHLORIDE
Active strength
200 mg/1
Pharmacologic classes
Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42494-308-064249403080660 TABLET in 1 BOTTLE (42494-308-06) 60 tablet2018-03-010000-00-00NoNoCurrent