Amiodarone HCl

Product NDC
63629-2001
11-digit product format
636292001
Labeler code
63629
Product ID
63629-2001_62c29c7a-b6bd-411e-983c-6d5756420835
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077069
Marketing category
ANDA
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
AMIODARONE HYDROCHLORIDE
Active strength
400 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
63629-2001-1EA - Each63629-20018466a3ef-fa30-4759-8841-e93e50f6fb4312021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2001-16362920010130 TABLET in 1 BOTTLE (63629-2001-1) 30 tablet2022-02-080000-00-00NoNoCurrent