amiodarone hydrochloride

Generic: amiodarone hydrochloride

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler cardinal health 107, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amiodarone hydrochloride 200 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-3365
Product ID 55154-3365_4add0af7-82cf-433f-9d96-4a0536de31ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075424
Marketing Start 2001-03-30
Marketing End 2027-01-31

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 551543365
Hyphenated Format 55154-3365

Supplemental Identifiers

RxCUI
833528
UPC
0055154336505
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 ANDA075424 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-3365-0) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

55154-3365-0 10 BLISTER PACK in 1 BAG (55154-3365-0) / 1 TABLET in 1 BLISTER PACK

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": "4add0af7-82cf-433f-9d96-4a0536de31ba", "openfda": {"upc": ["0055154336505"], "unii": ["976728SY6Z"], "rxcui": ["833528"], "spl_set_id": ["7bdc2236-3a1a-4210-a9fb-38f860227aa7"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-3365-0)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "55154-3365-0", "marketing_end_date": "20270131", "marketing_start_date": "20200420"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "55154-3365_4add0af7-82cf-433f-9d96-4a0536de31ba", "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": "55154-3365", "generic_name": "Amiodarone Hydrochloride", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA075424", "marketing_category": "ANDA", "marketing_end_date": "20270131", "marketing_start_date": "20010330"}