Amiodarone Hydrochloride

Product NDC
70934-280
11-digit product format
709340280
Labeler code
70934
Product ID
70934-280_f057a3e9-ea33-5eae-e053-2a95a90ac0bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA204742
Marketing category
ANDA
Marketing start
2019-02-13
Marketing end
2024-05-31
Substance
AMIODARONE HYDROCHLORIDE
Active strength
200 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
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-280-307093402803030 TABLET in 1 BOTTLE, PLASTIC (70934-280-30) 30 tablet2019-02-130000-00-00NoNoCurrent