LIPIODOL

Product NDC
67684-1901
11-digit product format
676841901
Labeler code
67684
Product ID
67684-1901_46155dba-f0cf-22b8-e063-6294a90a5997
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ethiodized oil
Dosage form
INJECTION
Route
INTRA-ARTERIAL; INTRALYMPHATIC; INTRAUTERINE
Labeler
Guerbet LLC
Application
NDA009190
Marketing category
NDA
Marketing start
2014-03-21
Substance
ETHIODIZED OIL
Active strength
480 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67684-1901DDiscontinued by firm2026-08-10
excluded packagepackage67684-190167684-1901-0DDiscontinued by firm2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67684-1901-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67684-1901-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67684-1901-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67684-1901-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67684-1901-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67684-1901-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67684-1901-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67684-1901-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67684-1901-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67684-1901-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67684-1901-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67684-1901-0557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N009190-001LIPIODOLETHIODIZED OILEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N009190-001LIPIODOLEQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)OIL / INTRALYMPHATIC, INTRAUTERINERLD, RS, Approved before 1982cb3db0bc1861…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N009190-001ODE-642021-04-0474a2ff9319b5…
2021-12-28 21:50 UTC2021-12N009190-001ODE-642021-04-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N009190-001ODE-642021-04-0487673890dc5c…
2021-03-12 10:30 UTC2021-03N009190-001ODE-642021-04-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N009190-001ODE-642021-04-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11N009190-001ODE-642021-04-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12N009190-001ODE-642021-04-043f01610625f2…
2019-09-15 20:21 UTC2019-09N009190-001ODE-642021-04-04b00525d2431f…
2019-07-19 19:46 UTC2019-07N009190-001ODE-642021-04-04ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
LIPIODOL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETHIODIZED OIL480 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KZW0R0686QInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
511d1f64-5cb9-4baa-a123-96205467e59aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

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 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

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

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 · 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 applno (NDA): 009190
application number: NDA009190
ndc (product): 67684-1901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67684-1901-1676841901011 AMPULE in 1 CARTON (67684-1901-1) / 10 mL in 1 AMPULE1 ampule2014-03-210000-00-00NoNoCurrent
67684-1901-2676841901021 VIAL in 1 CARTON (67684-1901-2) / 10 mL in 1 VIAL1 vial2018-09-280000-00-00NoNoCurrent