Amiodarone HCl

Product NDC
63629-2076
11-digit product format
636292076
Labeler code
63629
Product ID
63629-2076_b7acb460-a87d-43f9-b48c-7dc407390c26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
63629-2076-1EA - Each63629-20768baa57ab-a68d-42ce-839f-d1276e035a7a12021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2076-16362920760130 TABLET in 1 BOTTLE (63629-2076-1) 30 tablet2022-02-080000-00-00NoNoCurrent