Amiodarone HCl

Product NDC
42494-307
11-digit product format
424940307
Labeler code
42494
Product ID
42494-307_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
2017-01-01
Marketing end
0000-00-00
Substance
AMIODARONE HYDROCHLORIDE
Active strength
100 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42494-307-03EA - Each42494-307c5e16318-a82d-4c1d-8e31-150fbb58cc0b12018-04-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42494-307-034249403070330 TABLET in 1 BOTTLE (42494-307-03) 30 tablet2018-03-010000-00-00NoNoCurrent