OMNISCAN

Product NDC: 0407-0690
Requested package NDC: 0407-0690-20
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020123-001	OMNISCAN	287MG/ML	INJECTABLE / INJECTION	RLD, RS	1993-01-08	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

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

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0407-0690-05	OMNISCAN	5 mL in 1 VIAL	INJECTION	5	24
0407-0690-05	OMNISCAN	10 in 1 BOX	INJECTION	10	24
0407-0690-10	OMNISCAN	10 in 1 BOX	INJECTION	10	24
0407-0690-10	OMNISCAN	10 mL in 1 VIAL	INJECTION	10	24
0407-0690-12	OMNISCAN	10 mL in 1 SYRINGE, PLASTIC	INJECTION	10	24
0407-0690-12	OMNISCAN	10 in 1 BOX	INJECTION	10	24
0407-0690-15	OMNISCAN	15 mL in 1 VIAL	INJECTION	15	24
0407-0690-15	OMNISCAN	10 in 1 BOX	INJECTION	10	24
0407-0690-17	OMNISCAN	15 mL in 1 SYRINGE, PLASTIC	INJECTION	15	24
0407-0690-17	OMNISCAN	10 in 1 BOX	INJECTION	10	24
0407-0690-20	OMNISCAN	20 mL in 1 VIAL	INJECTION	20	24
0407-0690-20	OMNISCAN	10 in 1 BOX	INJECTION	10	24
0407-0690-22	OMNISCAN	10 in 1 BOX	INJECTION	10	24
0407-0690-22	OMNISCAN	20 mL in 1 SYRINGE, PLASTIC	INJECTION	20	24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0407-0690-05	ML - Milliliter	0407-0690	e31c732f-7b06-4f54-bce2-f0921970205d	1	2012-07-24
0407-0690-10	ML - Milliliter	0407-0690	ebee1b25-032f-4e22-a1e7-f5186f352d11	1	2012-07-24
0407-0690-12	ML - Milliliter	0407-0690	7524219d-cdea-4aa4-8476-ab2d47d1974a	1	2012-07-24
0407-0690-15	ML - Milliliter	0407-0690	f927c2da-4390-46f0-b188-eade667b8fc4	1	2012-07-24
0407-0690-17	ML - Milliliter	0407-0690	288f75cb-8dc0-40a3-8793-618c0dff519d	1	2012-07-24
0407-0690-20	ML - Milliliter	0407-0690	fec52cdd-0757-4e34-a007-e026c2bdda36	1	2012-07-24
0407-0690-22	ML - Milliliter	0407-0690	68414cf1-9fac-48a9-af13-b2278c50d3cb	1	2012-07-24
0407-0690-30	ML - Milliliter	0407-0690	a78db6c3-4902-49c6-a1a6-41a71c102ed1	1	2012-07-24
0407-0690-40	ML - Milliliter	0407-0690	3686026f-33e0-4686-a364-49c7c445d66b	1	2012-07-24
0407-0690-42	ML - Milliliter	0407-0690	7571ef70-47b3-425a-a9f4-bd91a4806976	1	2012-07-24
0407-0690-43	ML - Milliliter	0407-0690	4212db65-11dc-4ea3-9d46-92d752ebbde6	1	2012-07-24
0407-0690-50	ML - Milliliter	0407-0690	2048dc46-0517-46a2-88d8-054ae5a6bb31	1	2013-03-03
0407-0690-70	ML - Milliliter	0407-0690	dd9ec9e4-4a4d-408c-964c-438e91a77def	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
gadodiamide	ACTIVE INGREDIENT	84F6U3J2R6	OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]	11
gadodiamide	ACTIVE INGREDIENT	84F6U3J2R6	OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]	11
gadodiamide	ACTIVE MOIETY	84F6U3J2R6	OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]	11
gadodiamide	ACTIVE MOIETY	84F6U3J2R6	OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]	11
caldiamide sodium	INACTIVE INGREDIENT	1M6415C70M	OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]	11
caldiamide sodium	INACTIVE INGREDIENT	1M6415C70M	OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]	11
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]	11
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]	11
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]	11
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]	11
gadodiamide	ACTIVE INGREDIENT	84F6U3J2R6	OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]	2
gadodiamide	ACTIVE MOIETY	84F6U3J2R6	OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]	2
caldiamide sodium	INACTIVE INGREDIENT	1M6415C70M	OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]	2
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]	2
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	OMNISCAN (GADODIAMIDE) INJECTION [GE HEALTHCARE INC.]	2

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.

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 ndc (package): 0407-0690-20 ndc (product): 0407-0690 ndc11 (package): 00407069020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
84F6U3J2R6	GADODIAMIDE	131410-48-5	GADODIAMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0407-0690-20	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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OMNISCAN	GE Healthcare Inc. \| GE Healthcare AS \| GE Healthcare Ireland Limited \| GE Healthcare Shanghai Co., Ltd.	2025-04-18	HUMAN PRESCRIPTION DRUG LABEL	24
OMNISCAN	GE Healthcare Inc. \| GE Healthcare Ireland \| GE Healthcare AS	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	10
OMNISCAN	GE Healthcare Inc. \| GE Healthcare Ireland	2019-11-11	HUMAN PRESCRIPTION DRUG LABEL	15