ISOVUE-M 200

Product NDC: 52584-411
11-digit product format: 525840411
Labeler code: 52584
Product ID: 52584-411_ca95a1e5-fe0b-437f-b643-86e0bb6fe999
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Iopamidol
Dosage form: INJECTION, SOLUTION
Route: INTRATHECAL
Labeler: General Injectables & Vaccines, Inc.
Application: NDA018735
Marketing category: NDA
Marketing start: 2010-11-05
Marketing end: 0000-00-00
Substance: IOPAMIDOL
Active strength: 408 mg/mL
Pharmacologic classes: Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52584-411		I	Inactivated by FDA		2026-08-10
excluded package	package	52584-411	52584-411-11	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 · 34 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52584-411-11	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52584-411-11	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52584-411-11	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52584-411-11	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52584-411-11	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52584-411-11	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52584-411-11	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52584-411-11	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52584-411-11	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52584-411-11	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52584-411-11	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52584-411-11	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52584-411-11	2020-01-31	C162847	48780-1	9d75b9cf-ecc3-f424-e053-dadaa90a57ce	ISOVUE-M 200

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52584-411-11	ISOVUE-M 200	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10		3
52584-411-11	ISOVUE-M 200	1 in 1 BAG	INJECTION, SOLUTION	1		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Iopamidol	ACTIVE INGREDIENT	JR13W81H44	ISOVUE-M 200 (IOPAMIDOL) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.]	2
Iopamidol	ACTIVE MOIETY	JR13W81H44	ISOVUE-M 200 (IOPAMIDOL) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.]	2
Edetate Calcium Disodium	INACTIVE INGREDIENT	25IH6R4SGF	ISOVUE-M 200 (IOPAMIDOL) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.]	2
Tromethamine	INACTIVE INGREDIENT	023C2WHX2V	ISOVUE-M 200 (IOPAMIDOL) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52584-411	ISOVUE-M 200 (IOPAMIDOL) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.]	3	Legacy NDC, 2 package rows	20170118_60979ac0-024e-4dc8-9a84-c9195093c08d.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 · 2 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
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	Status
52584-411-11	52584041111	10 mL in 1 VIAL, SINGLE-DOSE	10 ml	Historical