Home NDC 0407-0690 OMNISCAN
Product NDC 0407-0690
11-digit product format 004070690
Labeler code 0407
Product ID 0407-0690_dfe2f58c-7a8f-408a-9690-6300a49eda17
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gadodiamide
Dosage form INJECTION
Route INTRAVENOUS
Labeler GE Healthcare Inc.
Application NDA020123
Marketing category NDA
Marketing start 2002-04-19
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 2026-12-31
Current FDA listing Yes 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 3 · 134 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020123-001 OMNISCAN GADODIAMIDE 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020123-001 OMNISCAN 287MG/ML INJECTABLE / INJECTION RLD, RS 1993-01-08 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base OMNISCAN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GADODIAMIDE 287 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 84F6U3J2R6 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0407-0690 OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.] 24 Current NDC, Legacy NDC, 14 package rows 20250426_1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0407-0690-05 00407069005 10 VIAL in 1 BOX (0407-0690-05) > 5 mL in 1 VIAL 10 vial 2002-04-19 0000-00-00 No No Current 0407-0690-10 00407069010 10 VIAL in 1 BOX (0407-0690-10) / 10 mL in 1 VIAL 10 vial 2002-04-19 0000-00-00 No No Current 0407-0690-12 00407069012 10 SYRINGE, PLASTIC in 1 BOX (0407-0690-12) > 10 mL in 1 SYRINGE, PLASTIC 2002-04-19 0000-00-00 No No Current 0407-0690-15 00407069015 10 VIAL in 1 BOX (0407-0690-15) / 15 mL in 1 VIAL 10 vial 2002-04-19 0000-00-00 No No Current 0407-0690-17 00407069017 10 SYRINGE, PLASTIC in 1 BOX (0407-0690-17) > 15 mL in 1 SYRINGE, PLASTIC 2002-04-19 0000-00-00 No No Current 0407-0690-20 00407069020 10 VIAL in 1 BOX (0407-0690-20) / 20 mL in 1 VIAL 10 vial 2002-04-19 0000-00-00 No No Current 0407-0690-22 00407069022 10 SYRINGE, PLASTIC in 1 BOX (0407-0690-22) > 20 mL in 1 SYRINGE, PLASTIC 2002-04-19 0000-00-00 No No Current 0407-0690-30 00407069030 10 VIAL in 1 BOX (0407-0690-30) > 10 mL in 1 VIAL 10 vial 2010-06-01 2024-05-05 No No Current 0407-0690-40 00407069040 10 VIAL in 1 BOX (0407-0690-40) > 15 mL in 1 VIAL 10 vial 2010-06-01 2024-04-10 No No Current 0407-0690-42 00407069042 10 SYRINGE in 1 BOX (0407-0690-42) > 15 mL in 1 SYRINGE 10 syringe 2010-06-01 0000-00-00 No No Current 0407-0690-43 00407069043 10 SYRINGE in 1 BOX (0407-0690-43) > 20 mL in 1 SYRINGE 10 syringe 2010-06-01 0000-00-00 No No Current 0407-0690-50 00407069050 10 VIAL in 1 BOX (0407-0690-50) > 20 mL in 1 VIAL 10 vial 2010-06-01 0000-00-00 No No Current 0407-0690-70 00407069070 10 BOTTLE, PLASTIC in 1 BOX (0407-0690-70) > 100 mL in 1 BOTTLE, PLASTIC 2007-10-02 0000-00-00 No No Current