ISOVUE

Product NDC: 0270-1316
11-digit product format: 002701316
Labeler code: 0270
Product ID: 0270-1316_2cb2e0be-08b1-e446-01c5-b1c50f1e797c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: IOPAMIDOL
Dosage form: INJECTION, SOLUTION
Route: INTRAVASCULAR
Labeler: BRACCO DIAGNOSTICS INC
Application: NDA018735
Marketing category: NDA
Marketing start: 1985-12-31
Substance: IOPAMIDOL
Active strength: 755 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0270-1316		D	Discontinued by firm	2026-08-10
excluded package	package	0270-1316	0270-1316-52	D	Discontinued by firm	2026-08-10
excluded package	package	0270-1316	0270-1316-41	D	Discontinued by firm	2026-08-10
excluded package	package	0270-1316	0270-1316-98	D	Discontinued by firm	2026-08-10

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0270-1316-41	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0270-1316-98	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0270-1316-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0270-1316-41	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0270-1316-98	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0270-1316-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0270-1316-41	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0270-1316-98	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0270-1316-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0270-1316-41	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0270-1316-98	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0270-1316-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0270-1316-41	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0270-1316-98	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0270-1316-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0270-1316-41	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0270-1316-98	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0270-1316-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0270-1316-41	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0270-1316-98	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0270-1316-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0270-1316-41	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0270-1316-98	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0270-1316-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0270-1316-41	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0270-1316-98	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0270-1316-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0270-1316-41	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0270-1316-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0270-1316-98	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0270-1316-41	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0270-1316-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0270-1316-98	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0270-1316-41	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0270-1316-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0270-1316-98	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018735-001	ISOVUE-M 200	IOPAMIDOL	41%	INJECTABLE / INJECTION	AP1	RLD, RS	1985-12-31
N018735-002	ISOVUE-300	IOPAMIDOL	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31
N018735-003	ISOVUE-370	IOPAMIDOL	76%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31
N018735-004	ISOVUE-M 300	IOPAMIDOL	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31
N018735-005	ISOVUE-128	IOPAMIDOL	26%	INJECTABLE / INJECTION			1986-10-21
N018735-006	ISOVUE-200	IOPAMIDOL	41%	INJECTABLE / INJECTION	AP2	RLD, RS	1987-07-07
N018735-007	ISOVUE-250	IOPAMIDOL	51%	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N018735-001	AP1
N018735-002	AP
N018735-003	AP
N018735-004	AP
N018735-006	AP2
N018735-007	AP

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N018735-002	I-975	2028-10-10
N018735-003	I-975	2028-10-10
N018735-006	I-975	2028-10-10
N018735-007	I-975	2028-10-10

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 8 · 287 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
2026-02-19 14:30 UTC	2026-02	N018735-001	ISOVUE-M 200	41%	INJECTABLE / INJECTION	AP1	RLD, RS	1985-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-002	ISOVUE-300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-003	ISOVUE-370	76%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-004	ISOVUE-M 300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-005	ISOVUE-128	26%	INJECTABLE / INJECTION			1986-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-006	ISOVUE-200	41%	INJECTABLE / INJECTION	AP2	RLD, RS	1987-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-007	ISOVUE-250	51%	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-001	ISOVUE-M 200	41%	INJECTABLE / INJECTION	AP1	RLD, RS	1985-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-002	ISOVUE-300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-003	ISOVUE-370	76%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-004	ISOVUE-M 300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-005	ISOVUE-128	26%	INJECTABLE / INJECTION			1986-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-006	ISOVUE-200	41%	INJECTABLE / INJECTION	AP2	RLD, RS	1987-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-007	ISOVUE-250	51%	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018735-001	ISOVUE-M 200	41%	INJECTABLE / INJECTION	AP1	RLD, RS	1985-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-002	ISOVUE-300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-003	ISOVUE-370	76%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-004	ISOVUE-M 300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-005	ISOVUE-128	26%	INJECTABLE / INJECTION			1986-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-006	ISOVUE-200	41%	INJECTABLE / INJECTION	AP2	RLD, RS	1987-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-007	ISOVUE-250	51%	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-001	ISOVUE-M 200	41%	INJECTABLE / INJECTION	AP1	RLD, RS	1985-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-002	ISOVUE-300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-003	ISOVUE-370	76%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-004	ISOVUE-M 300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-005	ISOVUE-128	26%	INJECTABLE / INJECTION			1986-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-006	ISOVUE-200	41%	INJECTABLE / INJECTION	AP2	RLD, RS	1987-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-007	ISOVUE-250	51%	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-001	ISOVUE-M 200	41%	INJECTABLE / INJECTION	AP1	RLD, RS	1985-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-002	ISOVUE-300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-003	ISOVUE-370	76%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-004	ISOVUE-M 300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-005	ISOVUE-128	26%	INJECTABLE / INJECTION			1986-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-006	ISOVUE-200	41%	INJECTABLE / INJECTION	AP2	RLD, RS	1987-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-007	ISOVUE-250	51%	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-001	ISOVUE-M 200	41%	INJECTABLE / INJECTION	AP1	RLD, RS	1985-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-002	ISOVUE-300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-003	ISOVUE-370	76%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-004	ISOVUE-M 300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-005	ISOVUE-128	26%	INJECTABLE / INJECTION			1986-10-21	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018735-001	AP1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-006	AP2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-007	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-001	AP1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-006	AP2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-007	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018735-001	AP1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-006	AP2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018735-007	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-001	AP1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-006	AP2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018735-007	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-001	AP1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-006	AP2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018735-007	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-001	AP1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-006	AP2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018735-007	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018735-001	AP1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018735-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018735-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018735-004	AP	1	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018735-002	I-975	2028-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-003	I-975	2028-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-006	I-975	2028-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018735-007	I-975	2028-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-002	I-975	2028-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-003	I-975	2028-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-006	I-975	2028-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018735-007	I-975	2028-10-10	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018735-002	I-975	2028-10-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018735-003	I-975	2028-10-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018735-006	I-975	2028-10-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018735-007	I-975	2028-10-10	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: ISOVUE
Brand name suffix: 370
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IOPAMIDOL	755 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JR13W81H44	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
ae8c18c9-3e7d-4515-b980-120025a88fc1	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
10141263-39cb-493e-b682-37b22a8d146d	Product name	2	20250625
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0270-1316-04	ISOVUE370	125 mL in 1 BOTTLE	INJECTION, SOLUTION	125	22
0270-1316-04	ISOVUE370	10 in 1 BOX	INJECTION, SOLUTION	10	22
0270-1316-30	ISOVUE370	10 in 1 BOX	INJECTION, SOLUTION	10	22
0270-1316-30	ISOVUE370	50 mL in 1 VIAL	INJECTION, SOLUTION	50	22
0270-1316-35	ISOVUE370	10 in 1 BOX	INJECTION, SOLUTION	10	22
0270-1316-35	ISOVUE370	100 mL in 1 BOTTLE	INJECTION, SOLUTION	100	22
0270-1316-37	ISOVUE370	10 in 1 BOX	INJECTION, SOLUTION	10	22
0270-1316-37	ISOVUE370	150 mL in 1 BOTTLE	INJECTION, SOLUTION	150	22
0270-1316-52	ISOVUE370	10 in 1 BOX	INJECTION, SOLUTION	10	22
0270-1316-52	ISOVUE370	75 mL in 1 BOTTLE	INJECTION, SOLUTION	75	22
0270-1316-45	ISOVUE370	10 in 1 BOX	INJECTION, SOLUTION	10	15
0270-1316-45	ISOVUE370	200 mL in 1 BOTTLE	INJECTION, SOLUTION	200	15
0270-1316-95	ISOVUE370	6 in 1 BOX	INJECTION, SOLUTION	6	15
0270-1316-95	ISOVUE370	500 mL in 1 BOTTLE	INJECTION, SOLUTION	500	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0270-1316-01	ML - Milliliter	0270-1316	3bef85ba-5914-4bc7-a471-51436d884ce5	1	2012-07-24
0270-1316-04	ML - Milliliter	0270-1316	f1506f20-fc45-4045-80c6-a496a308fe45	1	2012-07-24
0270-1316-30	ML - Milliliter	0270-1316	f5b2927c-e4fd-49a6-a68b-a8d74e397ebd	1	2015-08-04
0270-1316-35	ML - Milliliter	0270-1316	040b8526-a0e3-4321-b137-62a9811eb727	1	2012-07-24
0270-1316-37	ML - Milliliter	0270-1316	1e8fc5bf-29cf-499f-b11f-ebae22179e72	1	2012-07-24
0270-1316-41	ML - Milliliter	0270-1316	9444b013-4a98-4866-a69f-a534dc4b1942	1	2012-07-24
0270-1316-45	ML - Milliliter	0270-1316	ace099aa-7e12-4751-95c9-4fab40ff284e	1	2015-09-10
0270-1316-52	ML - Milliliter	0270-1316	f7bb58ac-24db-4812-b2ff-308060e398be	1	2012-07-24
0270-1316-95	ML - Milliliter	0270-1316	c1c9bf8e-b14e-417c-b26d-28b8fd8f8411	1	2015-09-10
0270-1316-98	ML - Milliliter	0270-1316	9164d072-c3d8-4c56-939f-f0056054b45b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IOPAMIDOL	ACTIVE INGREDIENT	JR13W81H44	ISOVUE 200 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]	7
IOPAMIDOL	ACTIVE MOIETY	JR13W81H44	ISOVUE 200 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]	7
EDETATE CALCIUM DISODIUM	INACTIVE INGREDIENT	25IH6R4SGF	ISOVUE 200 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]	7
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	ISOVUE 200 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]	7
IOPAMIDOL	ACTIVE INGREDIENT	JR13W81H44	ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]	4
IOPAMIDOL	ACTIVE MOIETY	JR13W81H44	ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]	4
EDETATE CALCIUM DISODIUM	INACTIVE INGREDIENT	25IH6R4SGF	ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]	4
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]	4
IOPAMIDOL	ACTIVE INGREDIENT	JR13W81H44	ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]	2
IOPAMIDOL	ACTIVE MOIETY	JR13W81H44	ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]	2
EDETATE CALCIUM DISODIUM	INACTIVE INGREDIENT	25IH6R4SGF	ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]	2
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0270-1316	ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 200 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]	19	Current NDC, Legacy NDC, 10 package rows	20250112_ae8c18c9-3e7d-4515-b980-120025a88fc1.zip
0270-1316	ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]	13	Current NDC, Legacy NDC, 4 package rows	20230510_797a11d7-dcd4-43ff-311b-3b48a10da2f2.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ISOVUE 200	IOPAMIDOL	BRACCO DIAGNOSTICS INC	ae8c18c9-3e7d-4515-b980-120025a88fc1	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018735 application number: NDA018735 ndc (product): 0270-1316
ISOVUE 300	IOPAMIDOL	Bracco Diagnostics Inc	797a11d7-dcd4-43ff-311b-3b48a10da2f2	2026-02-14	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 0270-1316
ISOVUE-M	IOPAMIDOL	Bracco Diagnostics Inc	11e893d2-0183-4581-b908-c8b7302c7edb	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018735 application number: NDA018735

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JR13W81H44	IOPAMIDOL	60166-93-0	IOPAMIDOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0270-1316-04	00270131604	10 BOTTLE in 1 BOX (0270-1316-04) / 125 mL in 1 BOTTLE	10 bottle	1985-12-31	0000-00-00	No	No	Current
0270-1316-30	00270131630	10 VIAL in 1 BOX (0270-1316-30) / 50 mL in 1 VIAL	10 vial	1985-12-31	0000-00-00	No	No	Current
0270-1316-35	00270131635	10 BOTTLE in 1 BOX (0270-1316-35) / 100 mL in 1 BOTTLE	10 bottle	1985-12-31	0000-00-00	No	No	Current
0270-1316-37	00270131637	10 BOTTLE in 1 BOX (0270-1316-37) / 150 mL in 1 BOTTLE	10 bottle	1985-12-31	0000-00-00	No	No	Current
0270-1316-41	00270131641	10 BOTTLE in 1 BOX (0270-1316-41) > 200 mL in 1 BOTTLE	10 bottle	1994-10-12	2021-11-01	No	No	Current
0270-1316-45	00270131645	10 BOTTLE in 1 BOX (0270-1316-45) / 200 mL in 1 BOTTLE	10 bottle	2014-06-20	0000-00-00	No	No	Current
0270-1316-52	00270131652	10 BOTTLE in 1 BOX (0270-1316-52) > 75 mL in 1 BOTTLE	10 bottle	1985-12-31	0000-00-00	No	No	Current
0270-1316-95	00270131695	6 BOTTLE in 1 BOX (0270-1316-95) / 500 mL in 1 BOTTLE	6 bottle	2014-06-20	0000-00-00	No	No	Current
0270-1316-98	00270131698	6 BOTTLE in 1 BOX (0270-1316-98) > 500 mL in 1 BOTTLE	6 bottle	1994-10-12	2021-11-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ISOVUE 300	BRACCO DIAGNOSTICS INC \| BRACCO IMAGING SPA \| BIPSO GmbH \| Patheon Italia S.p.A \| Labor LS SE & Co. KG \| S.M. FARMACEUTICI SRL \| BioChem Labor für biologishe und chemische Analytik GmbH	2026-03-10	HUMAN PRESCRIPTION DRUG LABEL	22
ISOVUE 300	Bracco Diagnostics Inc \| Patheon Italia S.p.A \| BRACCO IMAGING SPA \| BIPSO GmbH \| Labor LS SE & Co. KG \| BioChem Labor für biologishe und chemische Analytik GmbH \| S.M. FARMACEUTICI SRL	2026-02-14	HUMAN PRESCRIPTION DRUG LABEL	15
ISOVUE 250	Bracco Diagnostics Inc \| BRACCO IMAGING SPA \| BIPSO GmbH \| Labor LS SE & Co. KG \| Patheon Italia S.p.A	2022-03-02	HUMAN PRESCRIPTION DRUG LABEL	9