NDC 67684-1901

LIPIODOL

Ethiodized Oil

LIPIODOL is a Intra-arterial; Intralymphatic; Intrauterine Injection in the Human Prescription Drug category. It is labeled and distributed by Guerbet Llc. The primary component is Ethiodized Oil.

• Product ID: 67684-1901_5fe6f05c-cc4b-40ef-a59a-1d2223348ca5
• NDC: 67684-1901
• Product Type: Human Prescription Drug
• Proprietary Name: LIPIODOL
• Generic Name: Ethiodized Oil
• Dosage Form: Injection
• Route of Administration: INTRA-ARTERIAL; INTRALYMPHATIC; INTRAUTERINE
• Marketing Start Date: 2014-03-21
• Marketing Category: NDA / NDA
• Application Number: NDA009190
• Labeler Name: Guerbet LLC
• Substance Name: ETHIODIZED OIL
• Active Ingredient Strength: 480 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 67684-1901-1

1 AMPULE in 1 CARTON (67684-1901-1) > 10 mL in 1 AMPULE

• Marketing Start Date: 2014-03-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67684-1901-2 [67684190102]

LIPIODOL INJECTION

• Marketing Category: NDA
• Application Number: NDA009190
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-09-28

NDC 67684-1901-1 [67684190101]

LIPIODOL INJECTION

• Marketing Category: NDA
• Application Number: NDA009190
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-03-21

NDC 67684-1901-0 [67684190100]

LIPIODOL INJECTION

• Marketing Category: Unapproved drug for use in drug shor
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-05-25
• Marketing End Date: 2014-09-19

Drug Details

Active Ingredients

Ingredient	Strength
ETHIODIZED OIL	480 mg/mL

OpenFDA Data

• SPL SET ID: 511d1f64-5cb9-4baa-a123-96205467e59a
• Manufacturer:
  • Guerbet LLC
• UNII:
  • KZW0R0686Q

NDC Crossover Matching brand name "LIPIODOL" or generic name "Ethiodized Oil"

NDC	Brand Name	Generic Name
67684-1901	LIPIODOL	ethiodized oil
60694-1901	Lipiodol Ultra-Fluide	Ethiodized Oil