pacerone

Generic: amiodarone hydrochloride

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

Drug Facts

Product Profile

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

amiodarone hydrochloride 100 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2148
Product ID 72162-2148_b3dbe38d-29a3-41a9-a51c-0cc3bf8eb9e0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075135
Listing Expiration 2026-12-31
Marketing Start 2010-11-15

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 721622148
Hyphenated Format 72162-2148

Supplemental Identifiers

RxCUI
835956 835958
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 pacerone (source: ndc)
Generic Name amiodarone hydrochloride (source: ndc)
Application Number ANDA075135 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72162-2148-3)
source: ndc

Packages (1)

72162-2148-3 30 TABLET in 1 BOTTLE (72162-2148-3)

Ingredients (1)

amiodarone hydrochloride (100 mg/1)

Linked Drug Pages (1)

Pacerone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b3dbe38d-29a3-41a9-a51c-0cc3bf8eb9e0", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["835956", "835958"], "spl_set_id": ["dcadce9c-d0a0-4235-8ff8-dd93c09e03b3"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72162-2148-3)", "package_ndc": "72162-2148-3", "marketing_start_date": "20231207"}], "brand_name": "Pacerone", "product_id": "72162-2148_b3dbe38d-29a3-41a9-a51c-0cc3bf8eb9e0", "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": "72162-2148", "generic_name": "Amiodarone Hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pacerone", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA075135", "marketing_category": "ANDA", "marketing_start_date": "20101115", "listing_expiration_date": "20261231"}