OMNISCAN

Product NDC
0407-0691
11-digit product format
004070691
Labeler code
0407
Product ID
0407-0691_f1118736-777d-3d3a-e053-2a95a90a9a07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gadodiamide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
GE Healthcare Inc.
Application
NDA020123
Marketing category
NDA
Marketing start
2006-09-21
Marketing end
0000-00-00
Substance
GADODIAMIDE
Active strength
287 mg/mL
Pharmacologic classes
Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0407-0691DDiscontinued by firm2026-08-17
excluded productproduct0407-0691DDiscontinued by firm2026-08-17
excluded packagepackage0407-06910407-0691-64DDiscontinued by firm2026-08-17
excluded packagepackage0407-06910407-0691-65DDiscontinued by firm2026-08-17
excluded packagepackage0407-06910407-0691-62DDiscontinued by firm2026-08-17
excluded packagepackage0407-06910407-0691-63DDiscontinued by firm2026-08-17

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 2 · 72 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 productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-0691-64d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-0691-63d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-0691-65d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-0691-62d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-0691-64f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-0691-63f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-0691-65f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-0691-62f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0407-0691-642ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0407-0691-632ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0407-0691-652ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0407-0691-622ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0407-0691-64a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0407-0691-63a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0407-0691-65a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0407-0691-62a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0407-0691-64cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0407-0691-63cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0407-0691-65cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0407-0691-62cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0407-0691-64cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0407-0691-63cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0407-0691-65cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0407-0691-62cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0407-0691-64302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0407-0691-63302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0407-0691-65302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0407-0691-62302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0407-0691-64ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0407-0691-63ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0407-0691-65ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0407-0691-62ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0407-0691-640efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0407-0691-630efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0407-0691-650efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0407-0691-620efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0407-0691-64ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0407-0691-63ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0407-0691-65ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0407-0691-62ad56d346431e…cc804d4bbf1e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020123-001OMNISCANGADODIAMIDE287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-083f01610625f2…
2019-09-15 20:21 UTC2019-09N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020123-001OMNISCAN287MG/MLINJECTABLE / INJECTIONRLD, RS1993-01-08e64feba35796…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0407-0691-62ML - Milliliter0407-06917b161a3c-609c-410b-ad79-6029130cc9ad12012-07-24
0407-0691-63ML - Milliliter0407-06912e7ed77e-0ac2-47fc-9161-89719066b1ef12012-07-24

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
OMNISCANGADODIAMIDEGE Healthcare Inc.1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a2025-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020123
application number: NDA020123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0407-0691-620040706916210 SYRINGE, PLASTIC in 1 BOX (0407-0691-62) > 15 mL in 1 SYRINGE, PLASTIC2006-09-210000-00-00NoNoCurrent
0407-0691-630040706916310 SYRINGE, PLASTIC in 1 BOX (0407-0691-63) > 20 mL in 1 SYRINGE, PLASTIC2006-09-210000-00-00NoNoCurrent