amiodarone hydrochloride

Generic: amiodarone hydrochloride

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

amiodarone hydrochloride 50 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 72078-046
Product ID 72078-046_7cfc7c84-7d98-4060-bb6c-8268244be3cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076217
Listing Expiration 2026-12-31
Marketing Start 2023-06-09

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 72078046
Hyphenated Format 72078-046

Supplemental Identifiers

RxCUI
1663244 1663248
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 ANDA076217 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (72078-046-09) / 9 mL in 1 VIAL, GLASS (72078-046-00)
  • 1 VIAL, GLASS in 1 CARTON (72078-046-18) / 18 mL in 1 VIAL, GLASS
source: ndc

Packages (2)

72078-046-09 10 VIAL, GLASS in 1 CARTON (72078-046-09) / 9 mL in 1 VIAL, GLASS (72078-046-00) 72078-046-18 1 VIAL, GLASS in 1 CARTON (72078-046-18) / 18 mL in 1 VIAL, GLASS

Ingredients (1)

amiodarone hydrochloride (50 mg/mL)

Linked Drug Pages (1)

Amiodarone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7cfc7c84-7d98-4060-bb6c-8268244be3cb", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["1663244", "1663248"], "spl_set_id": ["f0b3b743-9f62-4b02-ace5-c8d93637ecad"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (72078-046-09)  / 9 mL in 1 VIAL, GLASS (72078-046-00)", "package_ndc": "72078-046-09", "marketing_start_date": "20230609"}, {"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (72078-046-18)  / 18 mL in 1 VIAL, GLASS", "package_ndc": "72078-046-18", "marketing_start_date": "20230609"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "72078-046_7cfc7c84-7d98-4060-bb6c-8268244be3cb", "dosage_form": "INJECTION, SOLUTION", "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": "72078-046", "generic_name": "amiodarone hydrochloride", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA076217", "marketing_category": "ANDA", "marketing_start_date": "20230609", "listing_expiration_date": "20261231"}