Amiodarone hydrochloride

Product NDC
65084-477
11-digit product format
650840477
Labeler code
65084
Product ID
65084-477_bb023713-964e-743a-e053-2a95a90abb50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
McKesson Corporation dba RX Pak
Application
ANDA079029
Marketing category
ANDA
Marketing start
2009-08-10
Marketing end
2021-02-28
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
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65084-477-102020-07-22C16284748780-1ab0e2407-26d2-f274-e053-dbdaa90a6471f6d05b43-caee-4a33-8103-4653ae41b275

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65084-477-106508404771010 BLISTER PACK in 1 BOX (65084-477-10) > 10 TABLET in 1 BLISTER PACK10 blister pack2019-11-152021-02-28NoNoCurrent