nexterone (amiodarone hci) (51662-1480)

Drug Facts

Product Profile

Brand Name nexterone (amiodarone hci)

Generic Name nexterone (amiodarone hci)

Labeler hf acquisition co llc, dba healthfirst

Dosage Form INJECTION, SOLUTION

Routes

INTRAVENOUS

Active Ingredients

amiodarone hydrochloride 1.5 mg/mL

Manufacturer

HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1480

Product ID 51662-1480_11c3bf02-6616-9353-e063-6394a90af9cd

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA022325

Listing Expiration 2026-12-31

Marketing Start 2020-01-29

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621480

Hyphenated Format 51662-1480

Supplemental Identifiers

RxCUI

849876 1046406

UNII

976728SY6Z

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nexterone (amiodarone hci) (source: ndc)

Generic Name nexterone (amiodarone hci) (source: ndc)

Application Number NDA022325 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

1.5 mg/mL

source: ndc

Packaging

1 BAG in 1 CARTON (51662-1480-1) / 100 mL in 1 BAG

source: ndc

Packages (1)

51662-1480-1 1 BAG in 1 CARTON (51662-1480-1) / 100 mL in 1 BAG

Ingredients (1)

amiodarone hydrochloride (1.5 mg/mL)

Linked Drug Pages (1)

NEXTERONE (AMIODARONE HCI) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVENOUS"], "spl_id": "11c3bf02-6616-9353-e063-6394a90af9cd", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["849876", "1046406"], "spl_set_id": ["9d4d66f7-fa14-e832-e053-2a95a90a8b62"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 CARTON (51662-1480-1)  / 100 mL in 1 BAG", "package_ndc": "51662-1480-1", "marketing_start_date": "20200129"}], "brand_name": "NEXTERONE (AMIODARONE HCI)", "product_id": "51662-1480_11c3bf02-6616-9353-e063-6394a90af9cd", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["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]"], "product_ndc": "51662-1480", "generic_name": "NEXTERONE (AMIODARONE HCI)", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NEXTERONE (AMIODARONE HCI)", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "1.5 mg/mL"}], "application_number": "NDA022325", "marketing_category": "NDA", "marketing_start_date": "20200129", "listing_expiration_date": "20261231"}