amiodarone hydrochloride (70436-232)

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride

Generic Name amiodarone hydrochloride

Labeler slate run pharmaceuticals

Dosage Form INJECTION, SOLUTION

Routes

INTRAVENOUS

Active Ingredients

amiodarone hydrochloride 50 mg/mL

Manufacturer

Slate Run Pharmaceuticals

Identifiers & Regulatory

Product NDC 70436-232

Product ID 70436-232_31c43944-e7af-8d8d-e063-6394a90a3b45

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA218253

Listing Expiration 2026-12-31

Marketing Start 2024-10-31

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 70436232

Hyphenated Format 70436-232

Supplemental Identifiers

RxCUI

1663224 1663244 1663248

UPC

0370436232741 0370436232734

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 ANDA218253 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

50 mg/mL

source: ndc

Packaging

1 VIAL in 1 CARTON (70436-232-50) / 18 mL in 1 VIAL
10 VIAL in 1 CARTON (70436-232-52) / 3 mL in 1 VIAL
10 VIAL in 1 CARTON (70436-232-62) / 9 mL in 1 VIAL

source: ndc

Packages (3)

70436-232-50 1 VIAL in 1 CARTON (70436-232-50) / 18 mL in 1 VIAL 70436-232-52 10 VIAL in 1 CARTON (70436-232-52) / 3 mL in 1 VIAL 70436-232-62 10 VIAL in 1 CARTON (70436-232-62) / 9 mL in 1 VIAL

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": "31c43944-e7af-8d8d-e063-6394a90a3b45", "openfda": {"upc": ["0370436232741", "0370436232734"], "unii": ["976728SY6Z"], "rxcui": ["1663224", "1663244", "1663248"], "spl_set_id": ["3a53668c-adda-44c2-a743-e79e467437e3"], "manufacturer_name": ["Slate Run Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (70436-232-50)  / 18 mL in 1 VIAL", "package_ndc": "70436-232-50", "marketing_start_date": "20241031"}, {"sample": false, "description": "10 VIAL in 1 CARTON (70436-232-52)  / 3 mL in 1 VIAL", "package_ndc": "70436-232-52", "marketing_start_date": "20241031"}, {"sample": false, "description": "10 VIAL in 1 CARTON (70436-232-62)  / 9 mL in 1 VIAL", "package_ndc": "70436-232-62", "marketing_start_date": "20241031"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "70436-232_31c43944-e7af-8d8d-e063-6394a90a3b45", "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": "70436-232", "generic_name": "amiodarone hydrochloride", "labeler_name": "Slate Run Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA218253", "marketing_category": "ANDA", "marketing_start_date": "20241031", "listing_expiration_date": "20261231"}