amiodarone hydrochloride

Generic: amiodarone hydrochloride

Labeler: mckesson corporation dba sky packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler mckesson corporation dba sky packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amiodarone hydrochloride 200 mg/1

Manufacturer
McKesson Corporation dba SKY Packaging

Identifiers & Regulatory

Product NDC 63739-051
Product ID 63739-051_29b5c6af-7797-c5c9-e063-6394a90a5e11
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079029
Marketing Start 2009-08-10
Marketing End 2026-03-31

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 63739051
Hyphenated Format 63739-051

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 ANDA079029 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BOX (63739-051-10) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

63739-051-10 10 BLISTER PACK in 1 BOX (63739-051-10) / 10 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": "29b5c6af-7797-c5c9-e063-6394a90a5e11", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["833528"], "spl_set_id": ["713db610-e2a9-438a-ab0c-c5b6d8e0693c"], "manufacturer_name": ["McKesson Corporation dba SKY Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BOX (63739-051-10)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "63739-051-10", "marketing_end_date": "20260331", "marketing_start_date": "20191206"}], "brand_name": "Amiodarone hydrochloride", "product_id": "63739-051_29b5c6af-7797-c5c9-e063-6394a90a5e11", "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": "63739-051", "generic_name": "Amiodarone hydrochloride", "labeler_name": "McKesson Corporation dba SKY Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA079029", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20090810"}