amiodarone hydrochloride

Generic: amiodarone hydrochloride

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amiodarone hydrochloride 100 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-097
Product ID 50268-097_47e23673-1380-50b5-e063-6394a90a9314
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075389
Listing Expiration 2027-12-31
Marketing Start 2019-09-11

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 50268097
Hyphenated Format 50268-097

Supplemental Identifiers

RxCUI
835956
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 ANDA075389 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-097-15) / 1 TABLET in 1 BLISTER PACK (50268-097-11)
source: ndc

Packages (1)

50268-097-15 50 BLISTER PACK in 1 BOX (50268-097-15) / 1 TABLET in 1 BLISTER PACK (50268-097-11)

Ingredients (1)

amiodarone hydrochloride (100 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": "47e23673-1380-50b5-e063-6394a90a9314", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["835956"], "spl_set_id": ["924c9359-ebc4-62a7-e053-2a95a90a4327"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-097-15)  / 1 TABLET in 1 BLISTER PACK (50268-097-11)", "package_ndc": "50268-097-15", "marketing_start_date": "20190911"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "50268-097_47e23673-1380-50b5-e063-6394a90a9314", "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": "50268-097", "generic_name": "Amiodarone Hydrochloride", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA075389", "marketing_category": "ANDA", "marketing_start_date": "20190911", "listing_expiration_date": "20271231"}