FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
55150-181
11-digit product format
551500181
Labeler code
55150
Product ID
55150-181_c2e4f552-4ed1-4c8c-b865-39596b79b1ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
AuroMedics Pharma LLC
Application
ANDA204550
Marketing category
ANDA
Marketing start
2017-10-25
Substance
AMIODARONE HYDROCHLORIDE
Active strength
450 mg/9mL
Pharmacologic classes
Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 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 HYDROCHLORIDE450 mg/9mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii976728SY6Z
Rxcui833532, 1663224, 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
55150-181-09Amiodarone Hydrochloride10 in 1 CARTONINJECTION, SOLUTION102
55150-181-09Amiodarone Hydrochloride9 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION92

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-181-09ML - Milliliter55150-18121ffcf21-f4b2-4faa-866d-28a120fe39e112018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-181AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]2Current NDC, Legacy NDC, 2 package rows20211212_6cd870d7-6381-421a-89bc-bce5c9518219.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1663224amiodarone HCl 150 MG in 3 ML InjectionPSN6cd870d7-6381-421a-89bc-bce5c95182192
1663244amiodarone HCl 450 MG in 9 ML InjectionPSN6cd870d7-6381-421a-89bc-bce5c95182192
833532amiodarone HCl 50 MG/ML Injectable SolutionPSN6cd870d7-6381-421a-89bc-bce5c95182192
16632243 ML amiodarone hydrochloride 50 MG/ML InjectionSCD6cd870d7-6381-421a-89bc-bce5c95182192
16632449 ML amiodarone hydrochloride 50 MG/ML InjectionSCD6cd870d7-6381-421a-89bc-bce5c95182192
833532amiodarone hydrochloride 50 MG/ML Injectable SolutionSCD6cd870d7-6381-421a-89bc-bce5c95182192
1663224amiodarone HCl 150 MG per 3 ML InjectionSY6cd870d7-6381-421a-89bc-bce5c95182192
1663244amiodarone HCl 450 MG per 9 ML InjectionSY6cd870d7-6381-421a-89bc-bce5c95182192
833532amiodarone hydrochloride 450 MG per 9 ML Injectable SolutionSY6cd870d7-6381-421a-89bc-bce5c95182192
833532amiodarone hydrochloride 900 MG per 18 ML Injectable SolutionSY6cd870d7-6381-421a-89bc-bce5c95182192

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-181-095515001810910 VIAL, SINGLE-DOSE in 1 CARTON (55150-181-09) / 9 mL in 1 VIAL, SINGLE-DOSE2017-10-250000-00-00NoNoCurrent