amiodarone hydrochloride

Generic: amiodarone hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amiodarone hydrochloride 400 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-4057
Product ID 51672-4057_4cc4c3cb-aced-a125-e063-6394a90aee93
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076362
Listing Expiration 2027-12-31
Marketing Start 2002-11-29

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 516724057
Hyphenated Format 51672-4057

Supplemental Identifiers

UPC
0351672405663 0351672405762 0351672405564
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 ANDA076362 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (51672-4057-0) / 10 TABLET in 1 BLISTER PACK
  • 30 TABLET in 1 BOTTLE (51672-4057-6)
source: ndc

Packages (2)

51672-4057-0 10 BLISTER PACK in 1 CARTON (51672-4057-0) / 10 TABLET in 1 BLISTER PACK 51672-4057-6 30 TABLET in 1 BOTTLE (51672-4057-6)

Ingredients (1)

amiodarone hydrochloride (400 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": "4cc4c3cb-aced-a125-e063-6394a90aee93", "openfda": {"upc": ["0351672405663", "0351672405762", "0351672405564"], "unii": ["976728SY6Z"], "spl_set_id": ["7ccd3733-c3af-4a11-8500-0f99194c1472"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (51672-4057-0)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "51672-4057-0", "marketing_start_date": "20021129"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (51672-4057-6)", "package_ndc": "51672-4057-6", "marketing_start_date": "20021129"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "51672-4057_4cc4c3cb-aced-a125-e063-6394a90aee93", "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": "51672-4057", "generic_name": "Amiodarone Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "400 mg/1"}], "application_number": "ANDA076362", "marketing_category": "ANDA", "marketing_start_date": "20021129", "listing_expiration_date": "20271231"}