Application 018956

Type: NDA
Sponsor: GE HEALTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMNIPAQUE 180	IOHEXOL	SOLUTION;INJECTION, ORAL, RECTAL	38.8%	Yes	Yes
002	OMNIPAQUE 240	IOHEXOL	SOLUTION;INJECTION, ORAL, RECTAL	51.8%	Yes	Yes
003	OMNIPAQUE 300	IOHEXOL	SOLUTION;INJECTION, ORAL, RECTAL	64.7%	Yes	Yes
004	OMNIPAQUE 350	IOHEXOL	SOLUTION;INJECTION, ORAL	75.5%	Yes	Yes
005	OMNIPAQUE 140	IOHEXOL	INJECTABLE;INJECTION	30.2%	Yes	Yes
006	OMNIPAQUE 210	IOHEXOL	INJECTABLE;INJECTION	45.3%	No	No
007	OMNIPAQUE 70	IOHEXOL	SOLUTION;URETHRAL	15.1%	No	No
008	OMNIPAQUE 9	IOHEXOL	SOLUTION;ORAL	1.9%	Yes	Yes
009	OMNIPAQUE 12	IOHEXOL	SOLUTION;ORAL	2.6%	Yes	Yes

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…`

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 (product): 0407-1414 ndc (product): 0407-1413 ndc (product): 0407-1415 ndc (product): 0407-1412 ndc (product): 0407-1401 ndc (product): 0407-1416 ndc (product): 0407-1411
Omnipaque	IOHEXOL	GE Healthcare	164b27b9-97ae-4279-896f-1c4afa583dd1	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 0407-1414 ndc (product): 0407-1413

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0407-1401	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1401	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1401	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1401	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1411	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1411	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1411	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1411	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1412	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1412	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1412	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1412	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1412	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1412	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1412	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1412	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1412	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1413	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1413	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1413	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1413	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1413	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1413	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1413	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1413	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1413	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1414	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1414	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1414	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1414	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1414	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1414	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1414	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1414	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1414	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1415	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1415	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1415	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1415	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1416	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1416	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1416	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current
0407-1416	OMNIPAQUE	Iohexol	GE Healthcare Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79850	SUPPL	2024-10-10
79842	SUPPL	2024-10-09
74082	SUPPL	2023-04-27
74073	SUPPL	2023-04-27
70268	SUPPL	2022-02-25
70219	SUPPL	2022-02-22
68311	SUPPL	2021-08-06
68304	SUPPL	2021-08-06
65971	SUPPL	2021-01-25
65157	SUPPL	2020-11-05
63801	SUPPL	2020-07-06
63800	SUPPL	2020-07-06
53761	SUPPL	2018-04-20
53733	SUPPL	2018-04-19
47966	SUPPL	2017-04-12
47896	SUPPL	2017-04-07
1153	SUPPL	2015-07-10
33672	SUPPL	2015-07-09
16130	SUPPL	2007-10-04
16129	SUPPL	2005-03-30
1152	SUPPL	2004-12-29
1151	SUPPL	2004-03-10
20171	SUPPL	2003-08-05
16128	SUPPL	2002-12-23
1150	SUPPL	2002-12-23
40833	SUPPL	1998-05-11