pacerone

Generic: amiodarone hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pacerone
Generic Name amiodarone hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amiodarone hydrochloride 200 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-787
Product ID 71610-787_f373ed89-c786-4f7c-a55e-2d1dc62971b0
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 71610787
Hyphenated Format 71610-787

Supplemental Identifiers

RxCUI
833528 834346
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
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71610-787-30)
source: ndc

Packages (1)

71610-787-30 30 TABLET in 1 BOTTLE (71610-787-30)

Ingredients (1)

amiodarone hydrochloride (200 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": "f373ed89-c786-4f7c-a55e-2d1dc62971b0", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["833528", "834346"], "spl_set_id": ["02f4a736-63ed-4ad4-a1f1-b21a71e928bd"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71610-787-30)", "package_ndc": "71610-787-30", "marketing_start_date": "20240125"}], "brand_name": "Pacerone", "product_id": "71610-787_f373ed89-c786-4f7c-a55e-2d1dc62971b0", "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": "71610-787", "generic_name": "Amiodarone Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pacerone", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA075135", "marketing_category": "ANDA", "marketing_start_date": "20101115", "listing_expiration_date": "20261231"}