amiodarone hydrochloride

Generic: amiodarone hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amiodarone hydrochloride 200 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1942
Product ID 71335-1942_5b27ec4d-eebc-445d-a4ab-fced073afaa6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213446
Listing Expiration 2026-12-31
Marketing Start 2020-09-01

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 713351942
Hyphenated Format 71335-1942

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 ANDA213446 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 200 TABLET in 1 BOTTLE (71335-1942-1)
  • 30 TABLET in 1 BOTTLE (71335-1942-2)
  • 60 TABLET in 1 BOTTLE (71335-1942-3)
  • 90 TABLET in 1 BOTTLE (71335-1942-4)
  • 10 TABLET in 1 BOTTLE (71335-1942-5)
source: ndc

Packages (5)

71335-1942-1 200 TABLET in 1 BOTTLE (71335-1942-1) 71335-1942-2 30 TABLET in 1 BOTTLE (71335-1942-2) 71335-1942-3 60 TABLET in 1 BOTTLE (71335-1942-3) 71335-1942-4 90 TABLET in 1 BOTTLE (71335-1942-4) 71335-1942-5 10 TABLET in 1 BOTTLE (71335-1942-5)

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": "5b27ec4d-eebc-445d-a4ab-fced073afaa6", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["833528"], "spl_set_id": ["8377eb89-0d62-48c5-90e7-e96d545a4642"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "200 TABLET in 1 BOTTLE (71335-1942-1)", "package_ndc": "71335-1942-1", "marketing_start_date": "20210903"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-1942-2)", "package_ndc": "71335-1942-2", "marketing_start_date": "20210903"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-1942-3)", "package_ndc": "71335-1942-3", "marketing_start_date": "20210903"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-1942-4)", "package_ndc": "71335-1942-4", "marketing_start_date": "20210903"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (71335-1942-5)", "package_ndc": "71335-1942-5", "marketing_start_date": "20210903"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "71335-1942_5b27ec4d-eebc-445d-a4ab-fced073afaa6", "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": "71335-1942", "generic_name": "Amiodarone Hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA213446", "marketing_category": "ANDA", "marketing_start_date": "20200901", "listing_expiration_date": "20261231"}