Amiodarone Hydrochloride

Product NDC
71872-7163
11-digit product format
718727163
Labeler code
71872
Product ID
71872-7163_fbbf8de0-338f-728d-e053-6294a90a5451
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amiodarone hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA076217
Marketing category
ANDA
Marketing start
2002-10-14
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 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
976728SY6ZAMIODARONE HYDROCHLORIDE19774-82-4AMIODARONE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71872-7163-1718727163011 VIAL, GLASS in 1 BAG (71872-7163-1) / 3 mL in 1 VIAL, GLASS2019-05-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amiodarone HydrochlorideMedical Purchasing Solutions, LLC2023-05-15HUMAN PRESCRIPTION DRUG LABEL2