amiodarone hydrochloride

Generic: amiodarone hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

amiodarone hydrochloride 200 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6993
Product ID 0904-6993_bb2b1ee4-07e4-4bf1-82bb-0c465a797646
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075424
Marketing Start 2001-03-30
Marketing End 2027-01-31

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 09046993
Hyphenated Format 0904-6993

Supplemental Identifiers

RxCUI
833528
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 ANDA075424 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-6993-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6993-61 100 BLISTER PACK in 1 CARTON (0904-6993-61) / 1 TABLET in 1 BLISTER PACK

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": "bb2b1ee4-07e4-4bf1-82bb-0c465a797646", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["833528"], "spl_set_id": ["352ed423-fc16-47bb-8e25-98e1c20f9991"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6993-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-6993-61", "marketing_end_date": "20270131", "marketing_start_date": "20200420"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "0904-6993_bb2b1ee4-07e4-4bf1-82bb-0c465a797646", "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": "0904-6993", "generic_name": "Amiodarone Hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA075424", "marketing_category": "ANDA", "marketing_end_date": "20270131", "marketing_start_date": "20010330"}