amiodarone hci

Generic: amiodarone hci

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiodarone hci
Generic Name amiodarone hci
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

amiodarone hydrochloride 50 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1363
Product ID 51662-1363_ef7bd6e6-d62f-7e93-e053-2a95a90aef83
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075761
Listing Expiration 2026-12-31
Marketing Start 2019-12-08

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 516621363
Hyphenated Format 51662-1363

Supplemental Identifiers

RxCUI
1663224
UPC
0363323616038
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 hci (source: ndc)
Generic Name amiodarone hci (source: ndc)
Application Number ANDA075761 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 3 mL in 1 VIAL, SINGLE-DOSE (51662-1363-1)
source: ndc

Packages (1)

51662-1363-1 3 mL in 1 VIAL, SINGLE-DOSE (51662-1363-1)

Ingredients (1)

amiodarone hydrochloride (50 mg/mL)

Linked Drug Pages (1)

AMIODARONE HCI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ef7bd6e6-d62f-7e93-e053-2a95a90aef83", "openfda": {"upc": ["0363323616038"], "unii": ["976728SY6Z"], "rxcui": ["1663224"], "spl_set_id": ["993b2557-6774-bb7a-e053-2995a90a0503"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "3 mL in 1 VIAL, SINGLE-DOSE (51662-1363-1)", "package_ndc": "51662-1363-1", "marketing_start_date": "20191208"}], "brand_name": "AMIODARONE HCI", "product_id": "51662-1363_ef7bd6e6-d62f-7e93-e053-2a95a90aef83", "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": "51662-1363", "generic_name": "AMIODARONE HCI", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMIODARONE HCI", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA075761", "marketing_category": "ANDA", "marketing_start_date": "20191208", "listing_expiration_date": "20261231"}