FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
71872-7149
11-digit product format
718727149
Labeler code
71872
Product ID
71872-7149_fbd8455e-7d35-e022-e053-6294a90aba6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA204550
Marketing category
ANDA
Marketing start
2017-10-25
Substance
AMIODARONE HYDROCHLORIDE
Active strength
150 mg/3mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
Amiodarone Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMIODARONE HYDROCHLORIDE150 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii976728SY6Z
Rxcui1663224

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
555d5389-223f-1ce8-3064-82307acfdb0dProduct name420250325
b88d5283-0ee6-f0b3-21f1-5522444ef3dfProduct name320210204
555d5389-223f-1ce8-3064-82307acfdb0dProduct name320171213
1f5577c0-bdff-03f7-f803-d1d3f05329c2Product name120140508
a0ee8fe5-e56a-6ca2-24dc-111ec6d188e4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71872-7149-1Amiodarone Hydrochloride1 in 1 BAGINJECTION, SOLUTION12
71872-7149-1Amiodarone Hydrochloride3 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7149AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]2Current NDC, Legacy NDC, 2 package rows20230517_81a15062-ba1e-37c0-e053-2991aa0af945.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1663224amiodarone HCl 150 MG in 3 ML InjectionPSN81a15062-ba1e-37c0-e053-2991aa0af9452
16632243 ML amiodarone hydrochloride 50 MG/ML InjectionSCD81a15062-ba1e-37c0-e053-2991aa0af9452
1663224amiodarone HCl 150 MG per 3 ML InjectionSY81a15062-ba1e-37c0-e053-2991aa0af9452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71872-7149-1718727149011 VIAL, SINGLE-DOSE in 1 BAG (71872-7149-1) / 3 mL in 1 VIAL, SINGLE-DOSE2018-12-050000-00-00NoNoCurrent