iodixanol (65219-383) | FunFoxMeds NDC

Drug Facts

Product Profile

Brand Name iodixanol

Generic Name iodixanol

Labeler fresenius kabi usa, llc

Dosage Form INJECTION, SOLUTION

Routes

INTRAVASCULAR

Active Ingredients

iodixanol 320 mg/mL

Manufacturer

FRESENIUS KABI USA, LLC

Identifiers & Regulatory

Product NDC 65219-383

Product ID 65219-383_1980ecbd-58c9-4176-af7f-af955bb0ad2e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA214271

Listing Expiration 2026-12-31

Marketing Start 2022-06-21

Pharmacologic Class

Established (EPC)

radiographic contrast agent [epc]

Mechanism of Action

x-ray contrast activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219383

Hyphenated Format 65219-383

Supplemental Identifiers

UNII

HW8W27HTXX

NUI

N0000180185 N0000010258

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 iodixanol (source: ndc)

Generic Name iodixanol (source: ndc)

Application Number ANDA214271 (source: ndc)

Routes

INTRAVASCULAR

source: ndc

Resolved Composition

Strengths

320 mg/mL

source: ndc

Packaging

10 BOTTLE, PLASTIC in 1 BOX (65219-383-05) / 50 mL in 1 BOTTLE, PLASTIC (65219-383-02)
10 BOTTLE, PLASTIC in 1 BOX (65219-383-10) / 100 mL in 1 BOTTLE, PLASTIC (65219-383-04)
10 BOTTLE, PLASTIC in 1 BOX (65219-383-50) / 150 mL in 1 BOTTLE, PLASTIC (65219-383-06)
10 BOTTLE, PLASTIC in 1 BOX (65219-383-70) / 200 mL in 1 BOTTLE, PLASTIC (65219-383-08)

source: ndc

Packages (4)

65219-383-05 10 BOTTLE, PLASTIC in 1 BOX (65219-383-05) / 50 mL in 1 BOTTLE, PLASTIC (65219-383-02) 65219-383-10 10 BOTTLE, PLASTIC in 1 BOX (65219-383-10) / 100 mL in 1 BOTTLE, PLASTIC (65219-383-04) 65219-383-50 10 BOTTLE, PLASTIC in 1 BOX (65219-383-50) / 150 mL in 1 BOTTLE, PLASTIC (65219-383-06) 65219-383-70 10 BOTTLE, PLASTIC in 1 BOX (65219-383-70) / 200 mL in 1 BOTTLE, PLASTIC (65219-383-08)

Ingredients (1)

iodixanol (320 mg/mL)

Linked Drug Pages (1)

Iodixanol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVASCULAR"], "spl_id": "1980ecbd-58c9-4176-af7f-af955bb0ad2e", "openfda": {"nui": ["N0000180185", "N0000010258"], "unii": ["HW8W27HTXX"], "spl_set_id": ["0fe89ea2-04f7-46c5-9c35-220d8c144a95"], "pharm_class_epc": ["Radiographic Contrast Agent [EPC]"], "pharm_class_moa": ["X-Ray Contrast Activity [MoA]"], "manufacturer_name": ["FRESENIUS KABI USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BOTTLE, PLASTIC in 1 BOX (65219-383-05)  / 50 mL in 1 BOTTLE, PLASTIC (65219-383-02)", "package_ndc": "65219-383-05", "marketing_start_date": "20220621"}, {"sample": false, "description": "10 BOTTLE, PLASTIC in 1 BOX (65219-383-10)  / 100 mL in 1 BOTTLE, PLASTIC (65219-383-04)", "package_ndc": "65219-383-10", "marketing_start_date": "20220621"}, {"sample": false, "description": "10 BOTTLE, PLASTIC in 1 BOX (65219-383-50)  / 150 mL in 1 BOTTLE, PLASTIC (65219-383-06)", "package_ndc": "65219-383-50", "marketing_start_date": "20220621"}, {"sample": false, "description": "10 BOTTLE, PLASTIC in 1 BOX (65219-383-70)  / 200 mL in 1 BOTTLE, PLASTIC (65219-383-08)", "package_ndc": "65219-383-70", "marketing_start_date": "20220621"}], "brand_name": "Iodixanol", "product_id": "65219-383_1980ecbd-58c9-4176-af7f-af955bb0ad2e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radiographic Contrast Agent [EPC]", "X-Ray Contrast Activity [MoA]"], "product_ndc": "65219-383", "generic_name": "Iodixanol", "labeler_name": "FRESENIUS KABI USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Iodixanol", "active_ingredients": [{"name": "IODIXANOL", "strength": "320 mg/mL"}], "application_number": "ANDA214271", "marketing_category": "ANDA", "marketing_start_date": "20220621", "listing_expiration_date": "20261231"}