amiodarone hydrochloride

Generic: amiodarone hydrochloride

Labeler: auromedics pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler auromedics pharma llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

amiodarone hydrochloride 450 mg/9mL

Manufacturer
AuroMedics Pharma LLC

Identifiers & Regulatory

Product NDC 55150-181
Product ID 55150-181_c2e4f552-4ed1-4c8c-b865-39596b79b1ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204550
Listing Expiration 2026-12-31
Marketing Start 2017-10-25

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 55150181
Hyphenated Format 55150-181

Supplemental Identifiers

RxCUI
833532 1663224 1663244
UPC
0355150180035 0355150182183 0355150181094
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 ANDA204550 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 450 mg/9mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-181-09) / 9 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-181-09 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-181-09) / 9 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

amiodarone hydrochloride (450 mg/9mL)

Linked Drug Pages (1)

Amiodarone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c2e4f552-4ed1-4c8c-b865-39596b79b1ad", "openfda": {"upc": ["0355150180035", "0355150182183", "0355150181094"], "unii": ["976728SY6Z"], "rxcui": ["833532", "1663224", "1663244"], "spl_set_id": ["6cd870d7-6381-421a-89bc-bce5c9518219"], "manufacturer_name": ["AuroMedics Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (55150-181-09)  / 9 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-181-09", "marketing_start_date": "20171025"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "55150-181_c2e4f552-4ed1-4c8c-b865-39596b79b1ad", "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 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "55150-181", "generic_name": "Amiodarone Hydrochloride", "labeler_name": "AuroMedics Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "450 mg/9mL"}], "application_number": "ANDA204550", "marketing_category": "ANDA", "marketing_start_date": "20171025", "listing_expiration_date": "20261231"}