Amiodarone hydrochloride

Product NDC
63629-7300
11-digit product format
636297300
Labeler code
63629
Product ID
63629-7300_ded19b13-99a4-47c6-86b6-5ca93aa47527
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7300-163629730001200 TABLET in 1 BOTTLE (63629-7300-1) 200 tablet2009-08-100000-00-00NoNoCurrent
63629-7300-26362973000230 TABLET in 1 BOTTLE (63629-7300-2) 30 tablet2009-08-100000-00-00NoNoCurrent
63629-7300-36362973000360 TABLET in 1 BOTTLE (63629-7300-3) 60 tablet2009-08-100000-00-00NoNoCurrent
63629-7300-46362973000490 TABLET in 1 BOTTLE (63629-7300-4) 90 tablet2018-06-210000-00-00NoNoCurrent
63629-7300-56362973000510 TABLET in 1 BOTTLE (63629-7300-5) 10 tablet2021-12-220000-00-00NoNoCurrent