amiodarone hydrochloride

Generic: amiodarone hydrochloride

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amiodarone hydrochloride 200 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-359
Product ID 29300-359_ca43a6d6-5537-4881-bf75-b43ade430dd1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213446
Listing Expiration 2026-12-31
Marketing Start 2020-09-01

Pharmacologic Class

Classes
antiarrhythmic [epc] cytochrome p450 1a2 inhibitors [moa] cytochrome p450 2c9 inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] p-glycoprotein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 29300359
Hyphenated Format 29300-359

Supplemental Identifiers

RxCUI
833528
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 amiodarone hydrochloride (source: ndc)
Generic Name amiodarone hydrochloride (source: ndc)
Application Number ANDA213446 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (29300-359-05)
  • 60 TABLET in 1 BOTTLE (29300-359-16)
source: ndc

Packages (2)

29300-359-05 500 TABLET in 1 BOTTLE (29300-359-05) 29300-359-16 60 TABLET in 1 BOTTLE (29300-359-16)

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": "ca43a6d6-5537-4881-bf75-b43ade430dd1", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["833528"], "spl_set_id": ["a20d0c03-cfda-49d1-88c9-be1bf295bc6c"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (29300-359-05)", "package_ndc": "29300-359-05", "marketing_start_date": "20200901"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (29300-359-16)", "package_ndc": "29300-359-16", "marketing_start_date": "20200901"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "29300-359_ca43a6d6-5537-4881-bf75-b43ade430dd1", "dosage_form": "TABLET", "pharm_class": ["Antiarrhythmic [EPC]", "Cytochrome P450 1A2 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "29300-359", "generic_name": "Amiodarone Hydrochloride", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA213446", "marketing_category": "ANDA", "marketing_start_date": "20200901", "listing_expiration_date": "20261231"}