NDC 67684-1901-01 - LIPIODOL

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
67684-1901
Requested NDC
67684-1901-01
Package NDCs from labels
67684-1901-1, 67684-1901-2, 67684-1901-01
Manufacturer
Guerbet LLC | Simafex | Jubilant HollisterStier General Partnership | RECIPHARM MONTS | IFTS
Effective date
2025-12-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LIPIODOL - Guerbet LLC | Simafex | Jubilant HollisterStier General Partnership | RECIPHARM MONTS | IFTSGuerbet LLC | Simafex | Jubilant HollisterStier General Partnership | RECIPHARM MONTS | IFTS2025-12-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67684-1901-1LIPIODOL1 in 1 CARTONINJECTION113
67684-1901-1LIPIODOL10 mL in 1 AMPULEINJECTION1013
67684-1901-2LIPIODOL1 in 1 CARTONINJECTION113
67684-1901-2LIPIODOL10 mL in 1 VIALINJECTION1013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67684-1901LIPIODOL (ETHIODIZED OIL) INJECTION [GUERBET LLC]11Current NDC, Legacy NDC, 4 package rows20250101_511d1f64-5cb9-4baa-a123-96205467e59a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67684-1901-1ML - Milliliter67684-19018c595ae1-1af0-4aca-b64f-f0b9d6e8a22e12015-01-05
67684-1901-2ML - Milliliter67684-1901bd2d3d6a-d6dd-4d32-ac31-38fc73f61ee212020-03-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHIODIZED OILACTIVE INGREDIENTKZW0R0686QLIPIODOL (ETHIODIZED OIL) INJECTION [GUERBET LLC]3
IODINEACTIVE MOIETY9679TC07X4LIPIODOL (ETHIODIZED OIL) INJECTION [GUERBET LLC]3
POPPY SEED OILINACTIVE INGREDIENT9G3Z76ES9JLIPIODOL (ETHIODIZED OIL) INJECTION [GUERBET LLC]3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIPIODOLETHIODIZED OILGuerbet LLC511d1f64-5cb9-4baa-a123-96205467e59a2025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA009190
ndc (package): 67684-1901-1
ndc (package): 67684-1901-2
ndc (product): 67684-1901
ndc11 (package): 67684190101
spl id: 46155dba-f0cf-22b8-e063-6294a90a5997
spl set id: 511d1f64-5cb9-4baa-a123-96205467e59a
unii: KZW0R0686Q

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.