amiodarone hydrochloride

Generic: amiodarone hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amiodarone hydrochloride 200 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-732
Product ID 65862-732_84ad18a0-1887-4b62-8ac1-94ace3433366
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204742
Listing Expiration 2027-12-31
Marketing Start 2016-06-03

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 65862732
Hyphenated Format 65862-732

Supplemental Identifiers

RxCUI
833528
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 amiodarone hydrochloride (source: ndc)
Generic Name amiodarone hydrochloride (source: ndc)
Application Number ANDA204742 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (65862-732-01)
  • 500 TABLET in 1 BOTTLE (65862-732-05)
  • 250 TABLET in 1 BOTTLE (65862-732-25)
  • 30 TABLET in 1 BOTTLE (65862-732-30)
  • 60 TABLET in 1 BOTTLE (65862-732-60)
  • 90 TABLET in 1 BOTTLE (65862-732-90)
  • 1000 TABLET in 1 BOTTLE (65862-732-99)
source: ndc

Packages (7)

65862-732-01 100 TABLET in 1 BOTTLE (65862-732-01) 65862-732-05 500 TABLET in 1 BOTTLE (65862-732-05) 65862-732-25 250 TABLET in 1 BOTTLE (65862-732-25) 65862-732-30 30 TABLET in 1 BOTTLE (65862-732-30) 65862-732-60 60 TABLET in 1 BOTTLE (65862-732-60) 65862-732-90 90 TABLET in 1 BOTTLE (65862-732-90) 65862-732-99 1000 TABLET in 1 BOTTLE (65862-732-99)

Ingredients (1)

amiodarone hydrochloride (200 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": "84ad18a0-1887-4b62-8ac1-94ace3433366", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["833528"], "spl_set_id": ["7ae393d1-7469-432a-9f21-f5ebab1207d1"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (65862-732-01)", "package_ndc": "65862-732-01", "marketing_start_date": "20160603"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65862-732-05)", "package_ndc": "65862-732-05", "marketing_start_date": "20160603"}, {"sample": false, "description": "250 TABLET in 1 BOTTLE (65862-732-25)", "package_ndc": "65862-732-25", "marketing_start_date": "20160603"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (65862-732-30)", "package_ndc": "65862-732-30", "marketing_start_date": "20160603"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (65862-732-60)", "package_ndc": "65862-732-60", "marketing_start_date": "20160603"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (65862-732-90)", "package_ndc": "65862-732-90", "marketing_start_date": "20160603"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65862-732-99)", "package_ndc": "65862-732-99", "marketing_start_date": "20160603"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "65862-732_84ad18a0-1887-4b62-8ac1-94ace3433366", "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": "65862-732", "generic_name": "Amiodarone Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA204742", "marketing_category": "ANDA", "marketing_start_date": "20160603", "listing_expiration_date": "20271231"}