FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
63323-616
11-digit product format
633230616
Labeler code
63323
Product ID
63323-616_262974e7-d551-4123-adfa-2ee1c4fa6195
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMIODARONE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA075761
Marketing category
ANDA
Marketing start
2003-01-28
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, 1663244

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
63323-616-01Amiodarone Hydrochloride3 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION36
63323-616-02Amiodarone Hydrochloride9 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION96
63323-616-03Amiodarone Hydrochloride25 in 1 TRAYINJECTION, SOLUTION256
63323-616-09Amiodarone Hydrochloride10 in 1 TRAYINJECTION, SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-616-01ML - Milliliter63323-616bf663fdf-9105-4a35-892b-60c1048a333b12024-07-12
63323-616-02ML - Milliliter63323-6166d41f106-aa48-4d74-b69e-fc5a025b2bc712021-11-09
63323-616-03ML - Milliliter63323-6166c9fe469-b588-48f6-894c-3f01eba1912d12012-07-24
63323-616-09ML - Milliliter63323-6168d677ab5-e7f3-486f-92c1-d43c5d514f7b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMIODARONE HYDROCHLORIDEACTIVE INGREDIENT976728SY6ZAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
AMIODARONEACTIVE MOIETYN3RQ532IUTAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-616AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 4 package rows20250416_d8d04647-8e25-4127-8ecf-360ce1991c2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1663224amiodarone HCl 150 MG in 3 ML InjectionPSNd8d04647-8e25-4127-8ecf-360ce1991c2f6
1663244amiodarone HCl 450 MG in 9 ML InjectionPSNd8d04647-8e25-4127-8ecf-360ce1991c2f6
16632243 ML amiodarone hydrochloride 50 MG/ML InjectionSCDd8d04647-8e25-4127-8ecf-360ce1991c2f6
16632449 ML amiodarone hydrochloride 50 MG/ML InjectionSCDd8d04647-8e25-4127-8ecf-360ce1991c2f6
1663224amiodarone HCl 150 MG per 3 ML InjectionSYd8d04647-8e25-4127-8ecf-360ce1991c2f6
1663244amiodarone HCl 450 MG per 9 ML InjectionSYd8d04647-8e25-4127-8ecf-360ce1991c2f6
1663224amiodarone HCl 150 MG in 3 ML InjectionPSN993b2557-6774-bb7a-e053-2995a90a05033
16632243 ML amiodarone hydrochloride 50 MG/ML InjectionSCD993b2557-6774-bb7a-e053-2995a90a05033
1663224amiodarone HCl 150 MG per 3 ML InjectionSY993b2557-6774-bb7a-e053-2995a90a05033
1663224amiodarone HCl 150 MG in 3 ML InjectionPSNd889c00c-e27e-4e27-e053-2995a90ad4e12
16632243 ML amiodarone hydrochloride 50 MG/ML InjectionSCDd889c00c-e27e-4e27-e053-2995a90ad4e12
1663224amiodarone HCl 150 MG per 3 ML InjectionSYd889c00c-e27e-4e27-e053-2995a90ad4e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-616-01633230616013 mL in 1 VIAL, SINGLE-DOSE3 mlHistorical
63323-616-02633230616029 mL in 1 VIAL, SINGLE-DOSE9 mlHistorical
63323-616-036332306160325 VIAL, SINGLE-DOSE in 1 TRAY (63323-616-03) / 3 mL in 1 VIAL, SINGLE-DOSE (63323-616-01) 2003-01-280000-00-00NoNoCurrent
63323-616-096332306160910 VIAL, SINGLE-DOSE in 1 TRAY (63323-616-09) / 9 mL in 1 VIAL, SINGLE-DOSE (63323-616-02) 2003-01-280000-00-00NoNoCurrent