OMNIPAQUE

Product NDC: 0407-1414
Requested package NDC: 0407-1414-95
11-digit product format: 004071414
Labeler code: 0407
Product ID: 0407-1414_61f3e388-89bf-43d6-ad51-b620fff561fb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Iohexol
Dosage form: INJECTION, SOLUTION
Route: INTRA-ARTICULAR; INTRAVASCULAR; INTRAVENOUS; ORAL
Labeler: GE Healthcare Inc.
Application: NDA018956
Marketing category: NDA
Marketing start: 1985-12-26
Substance: IOHEXOL
Active strength: 350 mg/mL
Pharmacologic classes: Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0407-1414	0407-1414-95	D	Discontinued by firm		2026-08-17

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 1 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`

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

Orange Book products#

Current product rows page 1 of 1 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018956-001	OMNIPAQUE 180	IOHEXOL	38.8%	SOLUTION / INJECTION, ORAL, RECTAL		RLD, RS	1985-12-26
N018956-002	OMNIPAQUE 240	IOHEXOL	51.8%	SOLUTION / INJECTION, ORAL, RECTAL		RLD, RS	1985-12-26
N018956-003	OMNIPAQUE 300	IOHEXOL	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	AP	RLD, RS	1985-12-26
N018956-004	OMNIPAQUE 350	IOHEXOL	75.5%	SOLUTION / INJECTION, ORAL	AP	RLD, RS	1985-12-26
N018956-005	OMNIPAQUE 140	IOHEXOL	30.2%	INJECTABLE / INJECTION		RLD, RS	1988-11-30
N018956-006	OMNIPAQUE 210	IOHEXOL	45.3%	INJECTABLE / INJECTION			1989-06-30
N018956-007	OMNIPAQUE 70	IOHEXOL	15.1%	SOLUTION / URETHRAL			1994-06-01
N018956-008	OMNIPAQUE 9	IOHEXOL	1.9%	SOLUTION / ORAL		RLD, RS	2018-04-17
N018956-009	OMNIPAQUE 12	IOHEXOL	2.6%	SOLUTION / ORAL		RLD, RS	2018-04-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N018956-003	AP
N018956-004	AP

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 10 · 378 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	N018956-001	OMNIPAQUE 180	38.8%	SOLUTION / INJECTION, ORAL, RECTAL		RLD, RS	1985-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018956-002	OMNIPAQUE 240	51.8%	SOLUTION / INJECTION, ORAL, RECTAL		RLD, RS	1985-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018956-003	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	AP	RLD, RS	1985-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018956-004	OMNIPAQUE 350	75.5%	SOLUTION / INJECTION, ORAL	AP	RLD, RS	1985-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018956-005	OMNIPAQUE 140	30.2%	INJECTABLE / INJECTION		RLD, RS	1988-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018956-006	OMNIPAQUE 210	45.3%	INJECTABLE / INJECTION			1989-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018956-007	OMNIPAQUE 70	15.1%	SOLUTION / URETHRAL			1994-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018956-008	OMNIPAQUE 9	1.9%	SOLUTION / ORAL		RLD, RS	2018-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018956-009	OMNIPAQUE 12	2.6%	SOLUTION / ORAL		RLD, RS	2018-04-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018956-001	OMNIPAQUE 180	38.8%	SOLUTION / INJECTION, ORAL, RECTAL		RLD, RS	1985-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018956-002	OMNIPAQUE 240	51.8%	SOLUTION / INJECTION, ORAL, RECTAL		RLD, RS	1985-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018956-003	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	AP	RLD, RS	1985-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018956-004	OMNIPAQUE 350	75.5%	SOLUTION / INJECTION, ORAL		RLD, RS	1985-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018956-005	OMNIPAQUE 140	30.2%	INJECTABLE / INJECTION		RLD, RS	1988-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018956-006	OMNIPAQUE 210	45.3%	INJECTABLE / INJECTION			1989-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018956-007	OMNIPAQUE 70	15.1%	SOLUTION / URETHRAL			1994-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018956-008	OMNIPAQUE 9	1.9%	SOLUTION / ORAL		RLD, RS	2018-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018956-009	OMNIPAQUE 12	2.6%	SOLUTION / ORAL		RLD, RS	2018-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018956-001	OMNIPAQUE 180	38.8%	SOLUTION / INJECTION, ORAL, RECTAL		RLD, RS	1985-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018956-002	OMNIPAQUE 240	51.8%	SOLUTION / INJECTION, ORAL, RECTAL		RLD, RS	1985-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018956-003	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	AP	RLD, RS	1985-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018956-004	OMNIPAQUE 350	75.5%	SOLUTION / INJECTION, ORAL		RLD, RS	1985-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018956-005	OMNIPAQUE 140	30.2%	INJECTABLE / INJECTION		RLD, RS	1988-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018956-006	OMNIPAQUE 210	45.3%	INJECTABLE / INJECTION			1989-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018956-007	OMNIPAQUE 70	15.1%	SOLUTION / URETHRAL			1994-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018956-008	OMNIPAQUE 9	1.9%	SOLUTION / ORAL		RLD, RS	2018-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018956-009	OMNIPAQUE 12	2.6%	SOLUTION / ORAL		RLD, RS	2018-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018956-001	OMNIPAQUE 180	38.8%	SOLUTION / INJECTION, ORAL, RECTAL		RLD, RS	1985-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018956-002	OMNIPAQUE 240	51.8%	SOLUTION / INJECTION, ORAL, RECTAL		RLD, RS	1985-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018956-003	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL		RLD, RS	1985-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018956-004	OMNIPAQUE 350	75.5%	SOLUTION / INJECTION, ORAL		RLD, RS	1985-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018956-005	OMNIPAQUE 140	30.2%	INJECTABLE / INJECTION		RLD, RS	1988-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018956-006	OMNIPAQUE 210	45.3%	INJECTABLE / INJECTION			1989-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018956-007	OMNIPAQUE 70	15.1%	SOLUTION / URETHRAL			1994-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018956-008	OMNIPAQUE 9	1.9%	SOLUTION / ORAL		RLD, RS	2018-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018956-009	OMNIPAQUE 12	2.6%	SOLUTION / ORAL		RLD, RS	2018-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018956-001	OMNIPAQUE 180	38.8%	SOLUTION / INJECTION, ORAL, RECTAL		RLD, RS	1985-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018956-002	OMNIPAQUE 240	51.8%	SOLUTION / INJECTION, ORAL, RECTAL		RLD, RS	1985-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018956-003	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL		RLD, RS	1985-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018956-004	OMNIPAQUE 350	75.5%	SOLUTION / INJECTION, ORAL		RLD, RS	1985-12-26	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N018956-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018956-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018956-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018956-003	AP	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018956-003	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018956-004	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: OMNIPAQUE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IOHEXOL	350 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4419T9MX03	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
eee15ebe-d349-4497-acef-6abe7a8247fb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0407-1414-03	OMNIPAQUE	150 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	150	19
0407-1414-03	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-04	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-04	OMNIPAQUE	200 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	200	19
0407-1414-20	OMNIPAQUE	75 mL in 1 BOTTLE, PLASTIC	INJECTION, SOLUTION	75	19
0407-1414-20	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-21	OMNIPAQUE	50 mL in 1 BOTTLE, PLASTIC	INJECTION, SOLUTION	50	19
0407-1414-21	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-22	OMNIPAQUE	100 mL in 1 BOTTLE, PLASTIC	INJECTION, SOLUTION	100	19
0407-1414-22	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-23	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-23	OMNIPAQUE	150 mL in 1 BOTTLE, PLASTIC	INJECTION, SOLUTION	150	19
0407-1414-24	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-24	OMNIPAQUE	200 mL in 1 BOTTLE, PLASTIC	INJECTION, SOLUTION	200	19
0407-1414-50	OMNIPAQUE	50 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	50	19
0407-1414-50	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-51	OMNIPAQUE	50 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	50	19
0407-1414-51	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-52	OMNIPAQUE	50 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	50	19
0407-1414-52	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-53	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-53	OMNIPAQUE	100 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	100	19
0407-1414-60	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-60	OMNIPAQUE	100 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	100	19
0407-1414-76	OMNIPAQUE	125 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	125	19
0407-1414-76	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-80	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-80	OMNIPAQUE	250 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	250	19
0407-1414-89	OMNIPAQUE	50 mL in 1 BOTTLE, PLASTIC	INJECTION, SOLUTION	50	19
0407-1414-89	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-90	OMNIPAQUE	75 mL in 1 BOTTLE, PLASTIC	INJECTION, SOLUTION	75	19
0407-1414-90	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-91	OMNIPAQUE	100 mL in 1 BOTTLE, PLASTIC	INJECTION, SOLUTION	100	19
0407-1414-91	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-93	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-93	OMNIPAQUE	150 mL in 1 BOTTLE, PLASTIC	INJECTION, SOLUTION	150	19
0407-1414-94	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-94	OMNIPAQUE	200 mL in 1 BOTTLE, PLASTIC	INJECTION, SOLUTION	200	19
0407-1414-95	OMNIPAQUE	125 mL in 1 BOTTLE, PLASTIC	INJECTION, SOLUTION	125	19
0407-1414-95	OMNIPAQUE	10 in 1 BOX	INJECTION, SOLUTION	10	19
0407-1414-72	Omnipaque	500 mL in 1 BOTTLE, PLASTIC	INJECTION, SOLUTION	500	13
0407-1414-72	Omnipaque	10 in 1 BOX	INJECTION, SOLUTION	10	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0407-1414-03	ML - Milliliter	0407-1414	bea144d9-8f56-4a19-9a68-fbae0a3f6947	1	2012-07-24
0407-1414-04	ML - Milliliter	0407-1414	7fdd0ef5-762f-49ec-8ba2-ceab5669e01d	1	2013-02-13
0407-1414-36	ML - Milliliter	0407-1414	20efe7db-fdc2-4cb7-975c-f3c0612d9c91	1	2013-02-11
0407-1414-41	ML - Milliliter	0407-1414	d90f3d62-7061-4308-a23e-c62fec78fa82	1	2012-07-24
0407-1414-44	ML - Milliliter	0407-1414	6d45f639-c20a-44ac-8218-5549900bd5f4	1	2012-07-24
0407-1414-45	ML - Milliliter	0407-1414	4fb4ca54-d115-457d-90c5-f0b7930a3d98	1	2012-07-24
0407-1414-48	ML - Milliliter	0407-1414	dcaad1b3-1651-4f6c-9d85-df2c73ce5268	1	2017-07-07
0407-1414-50	ML - Milliliter	0407-1414	80d315ca-7035-4aab-a8f2-07314c40f339	1	2012-07-24
0407-1414-51	ML - Milliliter	0407-1414	fa4beebd-4311-4da9-9c34-62e47cf4cab1	1	2012-07-24
0407-1414-60	ML - Milliliter	0407-1414	14dce833-e2c3-4734-a3c7-d844a53abe95	1	2012-07-24
0407-1414-72	ML - Milliliter	0407-1414	ae628c77-ab0b-4492-9f08-898999ad027b	1	2017-03-06
0407-1414-76	ML - Milliliter	0407-1414	7d22aa66-ccc9-4126-b6a9-950eb5190d3f	1	2012-07-24
0407-1414-82	ML - Milliliter	0407-1414	0e5f7463-2c86-427b-aac2-bc8ad9e4a606	1	2012-07-24
0407-1414-83	ML - Milliliter	0407-1414	b61f8c6c-3793-4b6a-a10c-890e48c155eb	1	2022-06-06
0407-1414-84	ML - Milliliter	0407-1414	b51f5b27-9e2b-4279-b153-61a1707fbc04	1	2012-07-24
0407-1414-85	ML - Milliliter	0407-1414	a8eba62a-5cf1-4474-8217-ef78ef8631b9	1	2012-07-24
0407-1414-86	ML - Milliliter	0407-1414	0ef5b96a-7c46-49ca-879d-0d08efffb210	1	2012-07-24
0407-1414-87	ML - Milliliter	0407-1414	67e3f00e-f22c-42ff-9934-e6f5e5bc8bba	1	2012-07-24
0407-1414-88	ML - Milliliter	0407-1414	ebede9e1-6ac6-43c2-9cca-ca17d402082f	1	2014-10-03
0407-1414-89	ML - Milliliter	0407-1414	5e132ad4-fa32-4759-ac13-3477af817311	1	2012-07-24
0407-1414-90	ML - Milliliter	0407-1414	d421e421-88ee-46b4-b4fc-e53276769345	1	2012-07-24
0407-1414-91	ML - Milliliter	0407-1414	1ba21b66-8d58-49a3-8eb9-7235f9779332	1	2012-07-24
0407-1414-93	ML - Milliliter	0407-1414	d568274d-2dd0-4681-a195-9c69692205f3	1	2012-07-24
0407-1414-94	ML - Milliliter	0407-1414	e760fd69-71d9-4133-89ab-c5412e861e04	1	2012-07-24
0407-1414-95	ML - Milliliter	0407-1414	e08b8138-5d25-46df-82e0-9a012a376fa3	1	2021-07-15
0407-1414-98	ML - Milliliter	0407-1414	741165a1-4b2a-4625-b7f1-0722bec949b3	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Iohexol	ACTIVE INGREDIENT	4419T9MX03	OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]	8
Iohexol	ACTIVE MOIETY	4419T9MX03	OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]	8
edetate calcium disodium	INACTIVE INGREDIENT	25IH6R4SGF	OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]	8
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]	8
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]	8
tromethamine	INACTIVE INGREDIENT	023C2WHX2V	OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]	8
Iohexol	ACTIVE INGREDIENT	4419T9MX03	OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]	6
Iohexol	ACTIVE MOIETY	4419T9MX03	OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]	6
Edetate calcium disodium	INACTIVE INGREDIENT	25IH6R4SGF	OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]	6
Hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]	6
Sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]	6
Tromethamine	INACTIVE INGREDIENT	023C2WHX2V	OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]	6
Iohexol	ACTIVE INGREDIENT	4419T9MX03	OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]	3
Iohexol	ACTIVE MOIETY	4419T9MX03	OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]	3
edetate calcium disodium	INACTIVE INGREDIENT	25IH6R4SGF	OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]	3
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]	3
Iodine	INACTIVE INGREDIENT	9679TC07X4	OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]	3
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]	3
tromethamine	INACTIVE INGREDIENT	023C2WHX2V	OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]	3
Iohexol	ACTIVE INGREDIENT	4419T9MX03	OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]	1
Iohexol	ACTIVE MOIETY	4419T9MX03	OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]	1
Edetate calcium disodium	INACTIVE INGREDIENT	25IH6R4SGF	OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]	1
Hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]	1
Tromethamine	INACTIVE INGREDIENT	023C2WHX2V	OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0407-1414	OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION OMNIPAQUE (IOHEXOL) SOLUTION [GE HEALTHCARE INC.]	18	Current NDC, Legacy NDC, 40 package rows	20241024_eee15ebe-d349-4497-acef-6abe7a8247fb.zip
0407-1414	OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION [GE HEALTHCARE]	11	Current NDC, Legacy NDC, 2 package rows	20241020_164b27b9-97ae-4279-896f-1c4afa583dd1.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OMNIPAQUE	IOHEXOL	Medical Purchasing Solutions, LLC	5088be1d-a708-1cac-e063-6394a90a2aff	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018956 application number: NDA018956
OMNIPAQUE	IOHEXOL	Medical Purchasing Solutions, LLC	508c42eb-f5e5-44f1-e063-6294a90a4d1f	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018956 application number: NDA018956
OMNIPAQUE	IOHEXOL	GE Healthcare Inc.	eee15ebe-d349-4497-acef-6abe7a8247fb	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018956 application number: NDA018956 ndc (package): 0407-1414-95 ndc (product): 0407-1414 ndc11 (package): 00407141495
Omnipaque	IOHEXOL	GE Healthcare	164b27b9-97ae-4279-896f-1c4afa583dd1	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 0407-1414

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4419T9MX03	IOHEXOL	66108-95-0	IOHEXOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0407-1414-95	00407141495	10 BOTTLE, PLASTIC in 1 BOX (0407-1414-95) > 125 mL in 1 BOTTLE, PLASTIC	2020-03-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OMNIPAQUE	GE Healthcare Inc. \| GE Healthcare Shanghai, Co., Ltd. \| GE Healthcare AS \| GE Healthcare Ireland \| GE Healthcare Lindesnes	2026-04-07	HUMAN PRESCRIPTION DRUG LABEL	19
Omnipaque	GE Healthcare \| GE Healthcare Ireland Limited \| GE Healthcare Lindesnes \| GE Healthcare Shanghai Co., Ltd.	2026-04-07	HUMAN PRESCRIPTION DRUG LABEL	13
OMNIPAQUE™ (iohexol) Injection 300 350	GE Healthcare Inc. \| GE Healthcare Ireland Limited \| GE Healthcare Lindesnes \| GE Healthcare Shanghai Co., Ltd.	2025-03-17	HUMAN PRESCRIPTION DRUG LABEL	17
OMNIPAQUE	GE Healthcare Inc. \| GE Healthcare AS \| GE Healthcare Lindesnes \| GE Healthcare Shanghai, Co., Ltd. \| GE Healthcare Ireland Limited	2024-08-15	HUMAN PRESCRIPTION DRUG LABEL	12
OMNIPAQUE™ (iohexol) Injection 300 350	GE Healthcare Inc. \| GE Healthcare Lindesnes \| GE Healthcare Shanghai Co., Ltd. \| GE Healthcare Ireland Limited	2024-08-15	HUMAN PRESCRIPTION DRUG LABEL	9
Omnipaque	GE Healthcare \| GE Healthcare Lindesnes \| GE Healthcare Shanghai Co., Ltd. \| GE Healthcare Ireland Limited	2024-08-15	HUMAN PRESCRIPTION DRUG LABEL	8