amiodarone hydrochloride

Generic: amiodarone hydrochloride

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler propharma distribution
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

amiodarone hydrochloride 50 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-153
Product ID 84549-153_462a9d14-baa5-8d4b-e063-6394a90a0d58
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076217
Listing Expiration 2026-12-31
Marketing Start 2002-10-14

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 84549153
Hyphenated Format 84549-153

Supplemental Identifiers

RxCUI
1663224
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 ANDA076217 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 3 mL in 1 VIAL, GLASS (84549-153-03)
source: ndc

Packages (1)

84549-153-03 3 mL in 1 VIAL, GLASS (84549-153-03)

Ingredients (1)

amiodarone hydrochloride (50 mg/mL)

Linked Drug Pages (1)

Amiodarone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "462a9d14-baa5-8d4b-e063-6394a90a0d58", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["1663224"], "spl_set_id": ["364ab45e-b525-f310-e063-6394a90a4421"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "3 mL in 1 VIAL, GLASS (84549-153-03)", "package_ndc": "84549-153-03", "marketing_start_date": "20250827"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "84549-153_462a9d14-baa5-8d4b-e063-6394a90a0d58", "dosage_form": "INJECTION, SOLUTION", "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": "84549-153", "generic_name": "amiodarone hydrochloride", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA076217", "marketing_category": "ANDA", "marketing_start_date": "20021014", "listing_expiration_date": "20261231"}