lipiodol

Generic: ethiodized oil

Labeler: guerbet llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lipiodol
Generic Name ethiodized oil
Labeler guerbet llc
Dosage Form INJECTION
Routes
INTRA-ARTERIAL INTRALYMPHATIC INTRAUTERINE
Active Ingredients

ethiodized oil 480 mg/mL

Manufacturer
Guerbet LLC

Identifiers & Regulatory

Product NDC 67684-1901
Product ID 67684-1901_46155dba-f0cf-22b8-e063-6294a90a5997
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA009190
Listing Expiration 2026-12-31
Marketing Start 2014-03-21

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 676841901
Hyphenated Format 67684-1901

Supplemental Identifiers

UNII
KZW0R0686Q
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 lipiodol (source: ndc)
Generic Name ethiodized oil (source: ndc)
Application Number NDA009190 (source: ndc)
Routes
INTRA-ARTERIAL INTRALYMPHATIC INTRAUTERINE
source: ndc

Resolved Composition

Strengths
  • 480 mg/mL
source: ndc
Packaging
  • 1 AMPULE in 1 CARTON (67684-1901-1) / 10 mL in 1 AMPULE
  • 1 VIAL in 1 CARTON (67684-1901-2) / 10 mL in 1 VIAL
source: ndc

Packages (2)

67684-1901-1 1 AMPULE in 1 CARTON (67684-1901-1) / 10 mL in 1 AMPULE 67684-1901-2 1 VIAL in 1 CARTON (67684-1901-2) / 10 mL in 1 VIAL

Ingredients (1)

ethiodized oil (480 mg/mL)

Linked Drug Pages (1)

LIPIODOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRA-ARTERIAL", "INTRALYMPHATIC", "INTRAUTERINE"], "spl_id": "46155dba-f0cf-22b8-e063-6294a90a5997", "openfda": {"nui": ["N0000180185", "N0000010258"], "unii": ["KZW0R0686Q"], "spl_set_id": ["511d1f64-5cb9-4baa-a123-96205467e59a"], "pharm_class_epc": ["Radiographic Contrast Agent [EPC]"], "pharm_class_moa": ["X-Ray Contrast Activity [MoA]"], "manufacturer_name": ["Guerbet LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 AMPULE in 1 CARTON (67684-1901-1)  / 10 mL in 1 AMPULE", "package_ndc": "67684-1901-1", "marketing_start_date": "20140321"}, {"sample": false, "description": "1 VIAL in 1 CARTON (67684-1901-2)  / 10 mL in 1 VIAL", "package_ndc": "67684-1901-2", "marketing_start_date": "20180928"}], "brand_name": "LIPIODOL", "product_id": "67684-1901_46155dba-f0cf-22b8-e063-6294a90a5997", "dosage_form": "INJECTION", "product_ndc": "67684-1901", "generic_name": "ethiodized oil", "labeler_name": "Guerbet LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LIPIODOL", "active_ingredients": [{"name": "ETHIODIZED OIL", "strength": "480 mg/mL"}], "application_number": "NDA009190", "marketing_category": "NDA", "marketing_start_date": "20140321", "listing_expiration_date": "20261231"}