IOMERVU

Product NDC: 0270-7018
11-digit product format: 002707018
Labeler code: 0270
Product ID: 0270-7018_50c571d8-759c-b711-b696-41c07a6ad82a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Iomeprol Injection
Dosage form: INJECTION, SOLUTION
Route: INTRA-ARTERIAL; INTRAVENOUS
Labeler: BRACCO DIAGNOSTICS INC
Application: NDA216016
Marketing category: NDA
Marketing start: 2026-01-01
Substance: IOMEPROL
Active strength: 816 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 1.

Orange Book products#

Current product rows page 1 of 1 · 13 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N216016-001	IOMERVU	IOMEPROL	25GM IODINE/100ML (250MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27
N216016-002	IOMERVU	IOMEPROL	15GM IODINE/50ML (300MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27
N216016-003	IOMERVU	IOMEPROL	30GM IODINE/100ML (300MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27
N216016-004	IOMERVU	IOMEPROL	45GM IODINE/150ML (300MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27
N216016-005	IOMERVU	IOMEPROL	60GM IODINE/200ML (300MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27
N216016-006	IOMERVU	IOMEPROL	17.5GM IODINE/50ML (350MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27
N216016-007	IOMERVU	IOMEPROL	35GM IODINE/100ML (350MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD, RS	2024-11-27
N216016-008	IOMERVU	IOMEPROL	52.5GM IODINE/150ML (350MG IODINE/ML	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27
N216016-009	IOMERVU	IOMEPROL	70GM IODINE/200ML (350MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD, RS	2024-11-27
N216016-010	IOMERVU	IOMEPROL	20GM IODINE/50ML (400MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27
N216016-011	IOMERVU	IOMEPROL	40GM IODINE/100ML (400MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD, RS	2024-11-27
N216016-012	IOMERVU	IOMEPROL	60GM IODINE/150ML (400MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27
N216016-013	IOMERVU	IOMEPROL	80GM IODINE/200ML (400MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD, RS	2024-11-27

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 13 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216016-001	NCE	2029-11-27
N216016-002	NCE	2029-11-27
N216016-003	NCE	2029-11-27
N216016-004	NCE	2029-11-27
N216016-005	NCE	2029-11-27
N216016-006	NCE	2029-11-27
N216016-007	NCE	2029-11-27
N216016-008	NCE	2029-11-27
N216016-009	NCE	2029-11-27
N216016-010	NCE	2029-11-27
N216016-011	NCE	2029-11-27
N216016-012	NCE	2029-11-27
N216016-013	NCE	2029-11-27

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 3 · 104 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216016-001	IOMERVU	25GM IODINE/100ML (250MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-002	IOMERVU	15GM IODINE/50ML (300MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-003	IOMERVU	30GM IODINE/100ML (300MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-004	IOMERVU	45GM IODINE/150ML (300MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-005	IOMERVU	60GM IODINE/200ML (300MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-006	IOMERVU	17.5GM IODINE/50ML (350MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-007	IOMERVU	35GM IODINE/100ML (350MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-008	IOMERVU	52.5GM IODINE/150ML (350MG IODINE/ML	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-009	IOMERVU	70GM IODINE/200ML (350MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-010	IOMERVU	20GM IODINE/50ML (400MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-011	IOMERVU	40GM IODINE/100ML (400MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-012	IOMERVU	60GM IODINE/150ML (400MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-013	IOMERVU	80GM IODINE/200ML (400MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-001	IOMERVU	25GM IODINE/100ML (250MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-002	IOMERVU	15GM IODINE/50ML (300MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-003	IOMERVU	30GM IODINE/100ML (300MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-004	IOMERVU	45GM IODINE/150ML (300MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-005	IOMERVU	60GM IODINE/200ML (300MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-006	IOMERVU	17.5GM IODINE/50ML (350MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-007	IOMERVU	35GM IODINE/100ML (350MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-008	IOMERVU	52.5GM IODINE/150ML (350MG IODINE/ML	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-009	IOMERVU	70GM IODINE/200ML (350MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-010	IOMERVU	20GM IODINE/50ML (400MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-011	IOMERVU	40GM IODINE/100ML (400MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-012	IOMERVU	60GM IODINE/150ML (400MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-013	IOMERVU	80GM IODINE/200ML (400MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216016-001	IOMERVU	25GM IODINE/100ML (250MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-002	IOMERVU	15GM IODINE/50ML (300MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-003	IOMERVU	30GM IODINE/100ML (300MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-004	IOMERVU	45GM IODINE/150ML (300MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-005	IOMERVU	60GM IODINE/200ML (300MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-006	IOMERVU	17.5GM IODINE/50ML (350MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-007	IOMERVU	35GM IODINE/100ML (350MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-008	IOMERVU	52.5GM IODINE/150ML (350MG IODINE/ML	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-009	IOMERVU	70GM IODINE/200ML (350MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-010	IOMERVU	20GM IODINE/50ML (400MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-011	IOMERVU	40GM IODINE/100ML (400MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-012	IOMERVU	60GM IODINE/150ML (400MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-013	IOMERVU	80GM IODINE/200ML (400MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD	2024-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216016-001	IOMERVU	25GM IODINE/100ML (250MG IODINE/ML)	SOLUTION / INTRA-ARTERIAL	RLD, RS	2024-11-27	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216016-001	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-002	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-003	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-004	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-005	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-006	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-007	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-008	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-009	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-010	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-011	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-012	NCE	2029-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216016-013	NCE	2029-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-001	NCE	2029-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-002	NCE	2029-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-003	NCE	2029-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-004	NCE	2029-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-005	NCE	2029-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-006	NCE	2029-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-007	NCE	2029-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-008	NCE	2029-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-009	NCE	2029-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-010	NCE	2029-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-011	NCE	2029-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-012	NCE	2029-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216016-013	NCE	2029-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216016-001	NCE	2029-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-002	NCE	2029-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-003	NCE	2029-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-004	NCE	2029-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-005	NCE	2029-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-006	NCE	2029-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-007	NCE	2029-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-008	NCE	2029-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-009	NCE	2029-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-010	NCE	2029-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-011	NCE	2029-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-012	NCE	2029-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216016-013	NCE	2029-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216016-001	NCE	2029-11-27	`fd3edfee7708…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IOMEPROL	816 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
17E17JBP8L	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
cb2e0e00-7c93-0fb4-89a5-861641662a5a	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0270-7018-26	IOMERVU	10 in 1 CASE	INJECTION, SOLUTION	10	4
0270-7018-26	IOMERVU	50 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	50	4
0270-7018-27	IOMERVU	100 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	100	4
0270-7018-27	IOMERVU	10 in 1 CASE	INJECTION, SOLUTION	10	4
0270-7018-28	IOMERVU	10 in 1 CASE	INJECTION, SOLUTION	10	4
0270-7018-28	IOMERVU	150 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	150	4
0270-7018-29	IOMERVU	10 in 1 CASE	INJECTION, SOLUTION	10	4
0270-7018-29	IOMERVU	200 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	200	4

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
IOMERVU	IOMEPROL INJECTION	BRACCO DIAGNOSTICS INC	cb2e0e00-7c93-0fb4-89a5-861641662a5a	2026-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216016 application number: NDA216016 ndc (product): 0270-7018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
17E17JBP8L	IOMEPROL	78649-41-9	IOMEPROL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0270-7018-26	00270701826	10 in 1 CASE				Historical
0270-7018-27	00270701827	10 BOTTLE, GLASS in 1 CASE (0270-7018-27) / 100 mL in 1 BOTTLE, GLASS	2026-01-01	No	No	Current
0270-7018-28	00270701828	10 in 1 CASE				Historical
0270-7018-29	00270701829	10 BOTTLE, GLASS in 1 CASE (0270-7018-29) / 200 mL in 1 BOTTLE, GLASS	2026-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Iomeprol Injection	BRACCO DIAGNOSTICS INC \| BIPSO GmbH \| SPIN S.p.A. \| BioChem Labor für biologishe und chemische Analytik GmbH	2026-02-05	HUMAN PRESCRIPTION DRUG LABEL	4