OMNIPAQUE

Product NDC: 71872-7370
Requested package NDC: 71872-7370-1
11-digit product format: 718727370
Labeler code: 71872
Product ID: 71872-7370_508c3891-4ffc-31df-e063-6394a90a99b6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Iohexol
Dosage form: INJECTION, SOLUTION
Route: INTRA-ARTICULAR; INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL
Labeler: Medical Purchasing Solutions, LLC
Application: NDA018956
Marketing category: NDA
Marketing start: 1985-12-26
Substance: IOHEXOL
Active strength: 300 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

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

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 · 387 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
2026-09-14 22:38:34	2026-08	N018956-001	OMNIPAQUE 180	38.8%	SOLUTION / INJECTION, ORAL, RECTAL		RLD, RS	1985-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018956-002	OMNIPAQUE 240	51.8%	SOLUTION / INJECTION, ORAL, RECTAL		RLD, RS	1985-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018956-003	OMNIPAQUE 300	64.7%	SOLUTION / INJECTION, ORAL, RECTAL	AP	RLD, RS	1985-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018956-004	OMNIPAQUE 350	75.5%	SOLUTION / INJECTION, ORAL	AP	RLD, RS	1985-12-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018956-005	OMNIPAQUE 140	30.2%	INJECTABLE / INJECTION		RLD, RS	1988-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018956-006	OMNIPAQUE 210	45.3%	INJECTABLE / INJECTION			1989-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018956-007	OMNIPAQUE 70	15.1%	SOLUTION / URETHRAL			1994-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018956-008	OMNIPAQUE 9	1.9%	SOLUTION / ORAL		RLD, RS	2018-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018956-009	OMNIPAQUE 12	2.6%	SOLUTION / ORAL		RLD, RS	2018-04-17	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N018956-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018956-004	AP	1	`84e616aacf4f…`
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…`

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: OMNIPAQUE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IOHEXOL	300 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
508c42eb-f5e5-44f1-e063-6294a90a4d1f	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	Strength	SPL version
71872-7370-1	OMNIPAQUE	1 in 1 BAG	INJECTION, SOLUTION	1		1
71872-7370-1	OMNIPAQUE	30 mL in 1 BOTTLE, PLASTIC	INJECTION, SOLUTION	30		1

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 · 3 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 ndc (package): 71872-7370-1 ndc (product): 71872-7370 ndc11 (package): 71872737001
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

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	Sample	Exclude flag	Status
71872-7370-1	71872737001	1 BOTTLE, PLASTIC in 1 BAG (71872-7370-1) / 30 mL in 1 BOTTLE, PLASTIC	2026-03-26	No	No	Current