Amiodarone Hydrochloride

Product NDC
71872-7000
11-digit product format
718727000
Labeler code
71872
Product ID
71872-7000_fe91f01c-a089-a2b2-e053-6394a90a79a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA077234
Marketing category
ANDA
Marketing start
2008-02-25
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMIODARONE HYDROCHLORIDE50 mg/mL

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
71872-7000-1Amiodarone Hydrochloride3 mL in 1 VIALINJECTION, SOLUTION35
71872-7000-1Amiodarone Hydrochloride1 in 1 BAGINJECTION, SOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7000AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]5Current NDC, Legacy NDC, 2 package rows20230621_66700f8b-3f76-3749-e053-2a91aa0adfdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1663224amiodarone HCl 150 MG in 3 ML InjectionPSN66700f8b-3f76-3749-e053-2a91aa0adfdb5
16632243 ML amiodarone hydrochloride 50 MG/ML InjectionSCD66700f8b-3f76-3749-e053-2a91aa0adfdb5
1663224amiodarone HCl 150 MG per 3 ML InjectionSY66700f8b-3f76-3749-e053-2a91aa0adfdb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71872-7000-1718727000011 VIAL in 1 BAG (71872-7000-1) / 3 mL in 1 VIAL1 vial2018-02-280000-00-00NoNoCurrent