amiodarone hydrochloride

Generic: amiodarone hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amiodarone hydrochloride 200 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5766
Product ID 50090-5766_144da1fc-bf68-44fc-a6ad-9f1d00d6838f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213446
Listing Expiration 2026-12-31
Marketing Start 2020-09-01

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 500905766
Hyphenated Format 50090-5766

Supplemental Identifiers

RxCUI
833528
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 ANDA213446 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (50090-5766-1)
  • 90 TABLET in 1 BOTTLE (50090-5766-2)
source: ndc

Packages (2)

50090-5766-1 30 TABLET in 1 BOTTLE (50090-5766-1) 50090-5766-2 90 TABLET in 1 BOTTLE (50090-5766-2)

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": "144da1fc-bf68-44fc-a6ad-9f1d00d6838f", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["833528"], "spl_set_id": ["c536e0ad-2758-4022-8242-f5e9b6aca1e2"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-5766-1)", "package_ndc": "50090-5766-1", "marketing_start_date": "20211004"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (50090-5766-2)", "package_ndc": "50090-5766-2", "marketing_start_date": "20211007"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "50090-5766_144da1fc-bf68-44fc-a6ad-9f1d00d6838f", "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": "50090-5766", "generic_name": "Amiodarone Hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA213446", "marketing_category": "ANDA", "marketing_start_date": "20200901", "listing_expiration_date": "20261231"}