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LIPIODOL

These highlights do not include all the information needed to use LIPIODOL safely and effectively. See full prescribing information for LIPIODOL. LIPIODOL® (Ethiodized Oil) Injection, for intrauterine, intralymphatic, or intra-arterial use Initial U.S. Approval: 1954

Approved
Approval ID

511d1f64-5cb9-4baa-a123-96205467e59a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 17, 2023

Manufacturers
FDA

Guerbet LLC

DUNS: 037876096

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ethiodized oil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67684-1901
Application NumberNDA009190
Product Classification
M
Marketing Category
C73594
G
Generic Name
ethiodized oil
Product Specifications
Route of AdministrationINTRALYMPHATIC, INTRAUTERINE, INTRA-ARTERIAL
Effective DateMay 5, 2018
FDA Product Classification

INGREDIENTS (2)

ETHIODIZED OILActive
Quantity: 480 mg in 1 mL
Code: KZW0R0686Q
Classification: ACTIM
POPPY SEED OILInactive
Code: 9G3Z76ES9J
Classification: IACT

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LIPIODOL - FDA Drug Approval Details