FDA.reportPublic FDA data

NEXTERONE (AMIODARONE HCI)

Product NDC
51662-1480
11-digit product format
516621480
Labeler code
51662
Product ID
51662-1480_11c3bf02-6616-9353-e063-6394a90af9cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NEXTERONE (AMIODARONE HCI)
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA022325
Marketing category
NDA
Marketing start
2020-01-29
Substance
AMIODARONE HYDROCHLORIDE
Active strength
1.5 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
NEXTERONE (AMIODARONE HCI)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMIODARONE HYDROCHLORIDE1.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii976728SY6Z
Rxcui849876, 1046406

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
555d5389-223f-1ce8-3064-82307acfdb0dProduct name420250325
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
b88d5283-0ee6-f0b3-21f1-5522444ef3dfProduct name320210204
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
555d5389-223f-1ce8-3064-82307acfdb0dProduct name320171213
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1f5577c0-bdff-03f7-f803-d1d3f05329c2Product name120140508
a0ee8fe5-e56a-6ca2-24dc-111ec6d188e4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1480-1NEXTERONE (AMIODARONE HCI)1 in 1 CARTONINJECTION, SOLUTION13
51662-1480-1NEXTERONE (AMIODARONE HCI)100 mL in 1 BAGINJECTION, SOLUTION1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1480NEXTERONE (AMIODARONE HCI) INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]3Current NDC, Legacy NDC, 2 package rows20240220_9d4d66f7-fa14-e832-e053-2a95a90a8b62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046406amiodarone HCl 150 MG in 100 ML InjectionPSN9d4d66f7-fa14-e832-e053-2a95a90a8b623
849876amiodarone HCl 360 MG in 200 ML InjectionPSN9d4d66f7-fa14-e832-e053-2a95a90a8b623
1046406100 ML amiodarone hydrochloride 1.5 MG/ML InjectionSCD9d4d66f7-fa14-e832-e053-2a95a90a8b623
849876200 ML amiodarone hydrochloride 1.8 MG/ML InjectionSCD9d4d66f7-fa14-e832-e053-2a95a90a8b623
1046406amiodarone HCl 150 MG per 100 ML InjectionSY9d4d66f7-fa14-e832-e053-2a95a90a8b623
849876amiodarone HCl 360 MG per 200 ML InjectionSY9d4d66f7-fa14-e832-e053-2a95a90a8b623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1480-1516621480011 BAG in 1 CARTON (51662-1480-1) / 100 mL in 1 BAG1 bag2020-01-290000-00-00NoNoCurrent