ISOVUE-M

Product NDC: 76381-411
11-digit product format: 763810411
Labeler code: 76381
Product ID: 76381-411_d038c2e6-5270-c2ac-9900-523456ef927c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: IOPAMIDOL
Dosage form: INJECTION, SOLUTION
Route: INTRATHECAL
Labeler: BIPSO GmbH
Application: NDA018735
Marketing category: NDA
Marketing start: 1985-12-31
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: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

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

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 · 301 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	N018735-001	ISOVUE-M 200	41%	INJECTABLE / INJECTION	AP1	RLD, RS	1985-12-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018735-002	ISOVUE-300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018735-003	ISOVUE-370	76%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018735-004	ISOVUE-M 300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018735-005	ISOVUE-128	26%	INJECTABLE / INJECTION			1986-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018735-006	ISOVUE-200	41%	INJECTABLE / INJECTION	AP2	RLD, RS	1987-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018735-007	ISOVUE-250	51%	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018735-001	ISOVUE-M 200	41%	INJECTABLE / INJECTION	AP1	RLD, RS	1985-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018735-002	ISOVUE-300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018735-003	ISOVUE-370	76%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018735-004	ISOVUE-M 300	61%	INJECTABLE / INJECTION	AP	RLD, RS	1985-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018735-005	ISOVUE-128	26%	INJECTABLE / INJECTION			1986-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018735-006	ISOVUE-200	41%	INJECTABLE / INJECTION	AP2	RLD, RS	1987-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018735-007	ISOVUE-250	51%	INJECTABLE / INJECTION	AP	RLD, RS	1992-07-06	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 135 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N018735-001	AP1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018735-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018735-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018735-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018735-006	AP2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018735-007	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018735-001	AP1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018735-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018735-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018735-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018735-006	AP2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018735-007	AP	1	`caaa826d4ba7…`
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…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N018735-002	I-975	2028-10-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018735-003	I-975	2028-10-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018735-006	I-975	2028-10-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018735-007	I-975	2028-10-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018735-002	I-975	2028-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018735-003	I-975	2028-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018735-006	I-975	2028-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018735-007	I-975	2028-10-10	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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