FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
72078-046
11-digit product format
720780046
Labeler code
72078
Product ID
72078-046_7cfc7c84-7d98-4060-bb6c-8268244be3cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amiodarone hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA076217
Marketing category
ANDA
Marketing start
2023-06-09
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
Rxcui1663244, 1663248

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
72078-046-00Amiodarone Hydrochloride9 mL in 1 VIAL, GLASSINJECTION, SOLUTION94
72078-046-09Amiodarone Hydrochloride10 in 1 CARTONINJECTION, SOLUTION104
72078-046-18Amiodarone Hydrochloride1 in 1 CARTONINJECTION, SOLUTION14
72078-046-18Amiodarone Hydrochloride18 mL in 1 VIAL, GLASSINJECTION, SOLUTION184

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72078-046-00ML - Milliliter72078-046fd16af5c-da59-499a-993d-1d6f2b22430f12025-02-10
72078-046-09ML - Milliliter72078-046dce9f97e-d712-4205-acab-ca0bd2a43c4712023-07-06
72078-046-18ML - Milliliter72078-046809db3ab-321d-4128-ba2d-015cb004994c12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72078-046AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]4Current NDC, 4 package rows20250115_f0b3b743-9f62-4b02-ace5-c8d93637ecad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1663244amiodarone HCl 450 MG in 9 ML InjectionPSNf0b3b743-9f62-4b02-ace5-c8d93637ecad4
1663248amiodarone HCl 900 MG in 18 ML InjectionPSNf0b3b743-9f62-4b02-ace5-c8d93637ecad4
166324818 ML amiodarone hydrochloride 50 MG/ML InjectionSCDf0b3b743-9f62-4b02-ace5-c8d93637ecad4
16632449 ML amiodarone hydrochloride 50 MG/ML InjectionSCDf0b3b743-9f62-4b02-ace5-c8d93637ecad4
1663244amiodarone HCl 450 MG per 9 ML InjectionSYf0b3b743-9f62-4b02-ace5-c8d93637ecad4
1663248amiodarone HCl 900 MG per 18 ML InjectionSYf0b3b743-9f62-4b02-ace5-c8d93637ecad4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72078-046-00720780046009 mL in 1 VIAL, GLASS9 mlHistorical
72078-046-097207800460910 VIAL, GLASS in 1 CARTON (72078-046-09) / 9 mL in 1 VIAL, GLASS (72078-046-00) 2023-06-09NoNoHistorical
72078-046-18720780046181 VIAL, GLASS in 1 CARTON (72078-046-18) / 18 mL in 1 VIAL, GLASS2023-06-09NoNoHistorical