nexterone

Generic: amiodarone hydrochloride

Labeler: baxter healthcare company
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nexterone
Generic Name amiodarone hydrochloride
Labeler baxter healthcare company
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

amiodarone hydrochloride 1.5 mg/mL

Manufacturer
Baxter Healthcare Company

Identifiers & Regulatory

Product NDC 43066-150
Product ID 43066-150_aff0eecb-d97f-44bd-b149-5115dcacec53
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022325
Listing Expiration 2026-12-31
Marketing Start 2010-11-16

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 43066150
Hyphenated Format 43066-150

Supplemental Identifiers

RxCUI
849876 1046406 1046408 1046410
UNII
976728SY6Z

Packaging Origin

Original Packager
true

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 (source: ndc)
Generic Name amiodarone hydrochloride (source: ndc)
Application Number NDA022325 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/mL
source: ndc
Packaging
  • 100 mL in 1 BAG (43066-150-10)
source: ndc

Packages (1)

43066-150-10 100 mL in 1 BAG (43066-150-10)

Ingredients (1)

amiodarone hydrochloride (1.5 mg/mL)

Linked Drug Pages (1)

Nexterone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "aff0eecb-d97f-44bd-b149-5115dcacec53", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["849876", "1046406", "1046408", "1046410"], "spl_set_id": ["e9108958-b8d7-4fba-87c3-9a32990de551"], "manufacturer_name": ["Baxter Healthcare Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BAG (43066-150-10)", "package_ndc": "43066-150-10", "marketing_start_date": "20101116"}], "brand_name": "Nexterone", "product_id": "43066-150_aff0eecb-d97f-44bd-b149-5115dcacec53", "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": "43066-150", "generic_name": "amiodarone hydrochloride", "labeler_name": "Baxter Healthcare Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nexterone", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "1.5 mg/mL"}], "application_number": "NDA022325", "marketing_category": "NDA", "marketing_start_date": "20101116", "listing_expiration_date": "20261231"}