ISOVUE

Product NDC: 76381-316
11-digit product format: 763810316
Labeler code: 76381
Product ID: 76381-316_31076157-8a24-15d8-2f7d-343ddf017bff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: IOPAMIDOL
Dosage form: INJECTION, SOLUTION
Route: INTRAVASCULAR
Labeler: BIPSO GmbH
Application: NDA020327
Marketing category: NDA
Marketing start: 1994-10-12
Marketing end: 0000-00-00
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: 2019-12-31
Current FDA listing: Historical FDA.report record

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020327-001	ISOVUE-200	IOPAMIDOL	41%	INJECTABLE / INJECTION		1994-10-12
N020327-002	ISOVUE-250	IOPAMIDOL	51%	INJECTABLE / INJECTION	RLD	1994-10-12
N020327-003	ISOVUE-300	IOPAMIDOL	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12
N020327-004	ISOVUE-370	IOPAMIDOL	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12

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 5 · 164 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	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020327-001	ISOVUE-200	41%	INJECTABLE / INJECTION		1994-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020327-002	ISOVUE-250	51%	INJECTABLE / INJECTION	RLD	1994-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020327-003	ISOVUE-300	61%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020327-004	ISOVUE-370	76%	INJECTABLE / INJECTION	RLD, RS	1994-10-12	`d06236e962d9…`

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
ISOVUE 300	IOPAMIDOL	Bracco Diagnostics Inc	797a11d7-dcd4-43ff-311b-3b48a10da2f2	2026-02-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020327 application number: NDA020327

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ISOVUE 200	BIPSO GmbH \| Takeda GmbH \| BRACCO IMAGING SPA	2018-12-17	HUMAN PRESCRIPTION DRUG LABEL	4

ISOVUE

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#