Home NDC 0407-0691 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 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.
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…
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OMNISCAN GADODIAMIDE GE Healthcare Inc. 1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a 2025-04-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020123 application number: NDA020123
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0407-0691-62 00407069162 10 SYRINGE, PLASTIC in 1 BOX (0407-0691-62) > 15 mL in 1 SYRINGE, PLASTIC 2006-09-21 0000-00-00 No No Current 0407-0691-63 00407069163 10 SYRINGE, PLASTIC in 1 BOX (0407-0691-63) > 20 mL in 1 SYRINGE, PLASTIC 2006-09-21 0000-00-00 No No Current