amiodarone hydrochloride

Generic: amiodarone hydrochloride

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amiodarone hydrochloride 100 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8607
Product ID 0615-8607_95e3bff0-e303-4661-85e9-1d8ea93c5671
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078578
Listing Expiration 2026-12-31
Marketing Start 2020-08-21

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 06158607
Hyphenated Format 0615-8607

Supplemental Identifiers

RxCUI
835956
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 amiodarone hydrochloride (source: ndc)
Generic Name amiodarone hydrochloride (source: ndc)
Application Number ANDA078578 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (0615-8607-39)
source: ndc

Packages (1)

0615-8607-39 30 TABLET in 1 BLISTER PACK (0615-8607-39)

Ingredients (1)

amiodarone hydrochloride (100 mg/1)

Linked Drug Pages (1)

Amiodarone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "95e3bff0-e303-4661-85e9-1d8ea93c5671", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["835956"], "spl_set_id": ["28cd0224-3569-4308-bd40-480bc4230503"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (0615-8607-39)", "package_ndc": "0615-8607-39", "marketing_start_date": "20251217"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "0615-8607_95e3bff0-e303-4661-85e9-1d8ea93c5671", "dosage_form": "TABLET", "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": "0615-8607", "generic_name": "Amiodarone Hydrochloride", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA078578", "marketing_category": "ANDA", "marketing_start_date": "20200821", "listing_expiration_date": "20261231"}