pacerone

Generic: amiodarone hydrochloride

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pacerone
Generic Name amiodarone hydrochloride
Labeler upsher-smith laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amiodarone hydrochloride 200 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0245-0147
Product ID 0245-0147_39e7666b-4916-2716-e063-6394a90a0589
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 02450147
Hyphenated Format 0245-0147

Supplemental Identifiers

RxCUI
833528 834346 834348 834350 835956 835958
UPC
0302450144304 0302450147602 0302451645305
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 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
  • 100 BLISTER PACK in 1 CARTON (0245-0147-01) / 1 TABLET in 1 BLISTER PACK (0245-0147-89)
  • 500 TABLET in 1 BOTTLE (0245-0147-15)
  • 60 TABLET in 1 BOTTLE (0245-0147-60)
  • 90 TABLET in 1 BOTTLE (0245-0147-90)
source: ndc

Packages (4)

0245-0147-01 100 BLISTER PACK in 1 CARTON (0245-0147-01) / 1 TABLET in 1 BLISTER PACK (0245-0147-89) 0245-0147-15 500 TABLET in 1 BOTTLE (0245-0147-15) 0245-0147-60 60 TABLET in 1 BOTTLE (0245-0147-60) 0245-0147-90 90 TABLET in 1 BOTTLE (0245-0147-90)

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": "39e7666b-4916-2716-e063-6394a90a0589", "openfda": {"upc": ["0302450144304", "0302450147602", "0302451645305"], "unii": ["976728SY6Z"], "rxcui": ["833528", "834346", "834348", "834350", "835956", "835958"], "spl_set_id": ["4c4ec9b0-13a5-49a8-b57b-b3f64e4316a7"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0245-0147-01)  / 1 TABLET in 1 BLISTER PACK (0245-0147-89)", "package_ndc": "0245-0147-01", "marketing_start_date": "20110119"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0245-0147-15)", "package_ndc": "0245-0147-15", "marketing_start_date": "20110119"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (0245-0147-60)", "package_ndc": "0245-0147-60", "marketing_start_date": "20110119"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (0245-0147-90)", "package_ndc": "0245-0147-90", "marketing_start_date": "20110119"}], "brand_name": "Pacerone", "product_id": "0245-0147_39e7666b-4916-2716-e063-6394a90a0589", "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": "0245-0147", "generic_name": "Amiodarone Hydrochloride", "labeler_name": "Upsher-Smith Laboratories, 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"}