Amiodarone hydrochloride

Product NDC
63739-051
11-digit product format
637390051
Labeler code
63739
Product ID
63739-051_bd9cb250-28d4-0e82-e053-2a95a90a2936
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-051-102020-07-22C16284748780-1ab0e2407-26c6-f274-e053-dbdaa90a6471713db610-e2a9-438a-ab0c-c5b6d8e0693c

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-051-10EA - Each63739-051f5db1340-f0a8-4c56-8414-a299c6d44bd712020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-051AMIODARONE HYDROCHLORIDE TABLET [MCKESSON CORPORATION DBA SKY PACKAGING]7Legacy NDC20241222_713db610-e2a9-438a-ab0c-c5b6d8e0693c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-051-106373900511010 BLISTER PACK in 1 BOX (63739-051-10) > 10 TABLET in 1 BLISTER PACK10 blister pack2019-12-060000-00-00NoNoCurrent