amiodarone hydrochloride (71335-1985)

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 71335-1985

Product ID 71335-1985_84684b63-4bba-483c-a253-c67cc80d8276

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078578

Listing Expiration 2026-12-31

Marketing Start 2020-03-09

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 713351985

Hyphenated Format 71335-1985

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 ANDA078578 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

200 mg/1

source: ndc

Packaging

200 TABLET in 1 BOTTLE (71335-1985-1)
30 TABLET in 1 BOTTLE (71335-1985-2)
60 TABLET in 1 BOTTLE (71335-1985-3)
90 TABLET in 1 BOTTLE (71335-1985-4)
10 TABLET in 1 BOTTLE (71335-1985-5)

source: ndc

Packages (5)

71335-1985-1 200 TABLET in 1 BOTTLE (71335-1985-1) 71335-1985-2 30 TABLET in 1 BOTTLE (71335-1985-2) 71335-1985-3 60 TABLET in 1 BOTTLE (71335-1985-3) 71335-1985-4 90 TABLET in 1 BOTTLE (71335-1985-4) 71335-1985-5 10 TABLET in 1 BOTTLE (71335-1985-5)

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": "84684b63-4bba-483c-a253-c67cc80d8276", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["833528"], "spl_set_id": ["f4532f12-3b7a-42ab-9a6c-36fd2a3f192c"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "200 TABLET in 1 BOTTLE (71335-1985-1)", "package_ndc": "71335-1985-1", "marketing_start_date": "20221013"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-1985-2)", "package_ndc": "71335-1985-2", "marketing_start_date": "20221013"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-1985-3)", "package_ndc": "71335-1985-3", "marketing_start_date": "20221013"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-1985-4)", "package_ndc": "71335-1985-4", "marketing_start_date": "20211029"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (71335-1985-5)", "package_ndc": "71335-1985-5", "marketing_start_date": "20221013"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "71335-1985_84684b63-4bba-483c-a253-c67cc80d8276", "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": "71335-1985", "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": "ANDA078578", "marketing_category": "ANDA", "marketing_start_date": "20200309", "listing_expiration_date": "20261231"}