amiodarone hydrochloride

Generic: amiodarone hydrochloride

Labeler: henry schein, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler henry schein, inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

amiodarone hydrochloride 50 mg/mL

Manufacturer
Henry Schein, Inc

Identifiers & Regulatory

Product NDC 0404-9815
Product ID 0404-9815_7bee583d-d110-411d-b6e2-4e1157594be7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076217
Marketing Start 2022-01-08
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 04049815
Hyphenated Format 0404-9815

Supplemental Identifiers

RxCUI
1663224
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 ANDA076217 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9815-03) / 3 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0404-9815-03 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9815-03) / 3 mL in 1 VIAL, SINGLE-DOSE

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": "7bee583d-d110-411d-b6e2-4e1157594be7", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["1663224"], "spl_set_id": ["545e9d26-0b4a-4784-b9c4-f8d62caf3a7c"], "manufacturer_name": ["Henry Schein, Inc"]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9815-03)  / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0404-9815-03", "marketing_end_date": "20260331", "marketing_start_date": "20220108"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "0404-9815_7bee583d-d110-411d-b6e2-4e1157594be7", "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": "0404-9815", "generic_name": "Amiodarone Hydrochloride", "labeler_name": "Henry Schein, Inc", "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_end_date": "20260331", "marketing_start_date": "20220108"}