Amiodarone Hydrochloride

Product NDC
0185-0144
11-digit product format
001850144
Labeler code
0185
Product ID
0185-0144_9f25b5e5-92eb-4945-b026-d414e7041f76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Eon Labs, Inc.
Application
ANDA075315
Marketing category
ANDA
Marketing start
1998-12-23
Marketing end
2022-07-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-0144-05EA - Each0185-0144fb6a621e-4f90-45f9-9c6a-ba7c2e09e0b212012-07-24
0185-0144-09EA - Each0185-014406e665be-a368-4721-a8a6-9773ed1398bf12012-07-24
0185-0144-60EA - Each0185-01448bd45642-e16b-4b12-8eb7-940eb0f5f8b112012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0185-0144-0500185014405500 TABLET in 1 BOTTLE (0185-0144-05) 500 tablet1998-12-232022-07-31NoNoCurrent
0185-0144-090018501440990 TABLET in 1 BOTTLE (0185-0144-09) 90 tablet1998-12-232021-07-31NoNoCurrent
0185-0144-600018501446060 TABLET in 1 BOTTLE (0185-0144-60) 60 tablet1998-12-232022-07-31NoNoCurrent