amiodarone hydrochloride

Generic: amiodarone hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

amiodarone hydrochloride 50 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9875
Product ID 0143-9875_624376cc-5fa3-410a-95de-ef975e2ea501
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077234
Listing Expiration 2026-12-31
Marketing Start 2008-02-25

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 01439875
Hyphenated Format 0143-9875

Supplemental Identifiers

RxCUI
1663224
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 ANDA077234 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 BOX (0143-9875-10) / 3 mL in 1 VIAL (0143-9875-01)
  • 25 VIAL in 1 BOX (0143-9875-25) / 3 mL in 1 VIAL (0143-9875-01)
source: ndc

Packages (2)

0143-9875-10 10 VIAL in 1 BOX (0143-9875-10) / 3 mL in 1 VIAL (0143-9875-01) 0143-9875-25 25 VIAL in 1 BOX (0143-9875-25) / 3 mL in 1 VIAL (0143-9875-01)

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": "624376cc-5fa3-410a-95de-ef975e2ea501", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["1663224"], "spl_set_id": ["51772745-9ea9-42cd-97e6-7266f41ae3ca"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 BOX (0143-9875-10)  / 3 mL in 1 VIAL (0143-9875-01)", "package_ndc": "0143-9875-10", "marketing_start_date": "20080225"}, {"sample": false, "description": "25 VIAL in 1 BOX (0143-9875-25)  / 3 mL in 1 VIAL (0143-9875-01)", "package_ndc": "0143-9875-25", "marketing_start_date": "20080225"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "0143-9875_624376cc-5fa3-410a-95de-ef975e2ea501", "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": "0143-9875", "generic_name": "Amiodarone Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA077234", "marketing_category": "ANDA", "marketing_start_date": "20080225", "listing_expiration_date": "20261231"}