amiodarone hydrochloride

Generic: amiodarone hydrochloride

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

Drug Facts

Product Profile

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

amiodarone hydrochloride 200 mg/1

Manufacturer
Advagen Pharma Limited

Identifiers & Regulatory

Product NDC 72888-039
Product ID 72888-039_458014a5-2f16-9815-e063-6294a90ad169
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078578
Listing Expiration 2026-12-31
Marketing Start 2020-03-09

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 72888039
Hyphenated Format 72888-039

Supplemental Identifiers

RxCUI
833528 834348 835956
UPC
0372888060309 0372888039053 0372888061306
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 ANDA078578 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (72888-039-05)
  • 10 BLISTER PACK in 1 CARTON (72888-039-09) / 10 TABLET in 1 BLISTER PACK
  • 60 TABLET in 1 BOTTLE (72888-039-60)
source: ndc

Packages (3)

72888-039-05 500 TABLET in 1 BOTTLE (72888-039-05) 72888-039-09 10 BLISTER PACK in 1 CARTON (72888-039-09) / 10 TABLET in 1 BLISTER PACK 72888-039-60 60 TABLET in 1 BOTTLE (72888-039-60)

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": "458014a5-2f16-9815-e063-6294a90ad169", "openfda": {"upc": ["0372888060309", "0372888039053", "0372888061306"], "unii": ["976728SY6Z"], "rxcui": ["833528", "834348", "835956"], "spl_set_id": ["d911b4cf-eec4-43f8-aa64-cc60cfc901b9"], "manufacturer_name": ["Advagen Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (72888-039-05)", "package_ndc": "72888-039-05", "marketing_start_date": "20200309"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (72888-039-09)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "72888-039-09", "marketing_start_date": "20200309"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (72888-039-60)", "package_ndc": "72888-039-60", "marketing_start_date": "20200309"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "72888-039_458014a5-2f16-9815-e063-6294a90ad169", "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": "72888-039", "generic_name": "Amiodarone Hydrochloride", "labeler_name": "Advagen Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA078578", "marketing_category": "ANDA", "marketing_start_date": "20200309", "listing_expiration_date": "20261231"}