Amiodarone Hydrochloride

Product NDC
70518-2792
11-digit product format
705182792
Labeler code
70518
Product ID
70518-2792_e5314c67-69c7-d494-e053-2995a90acf00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMIODARONE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA075761
Marketing category
ANDA
Marketing start
2020-06-19
Marketing end
0000-00-00
Substance
AMIODARONE HYDROCHLORIDE
Active strength
50 mg/mL
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2792-12022-02-02C16284748780-1d6a99b39-aea6-a426-e053-dadaa90af4c217a1383b-fdff-4054-8815-d5ef47d892e0
70518-2792-12022-01-28C16284748780-1d6a99b39-aea6-a426-e053-dadaa90af4c217a1383b-fdff-4054-8815-d5ef47d892e0

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2792-17051827920125 VIAL, SINGLE-DOSE in 1 TRAY (70518-2792-1) > 3 mL in 1 VIAL, SINGLE-DOSE (70518-2792-0) 2020-06-190000-00-00NoNoCurrent