Application 010040

Type: NDA
Sponsor: BRACCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RENOGRAFIN-76	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	INJECTABLE;INJECTION	66%;10%	Yes	No
006	RENOGRAFIN-60	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	INJECTABLE;INJECTION	52%;8%	No	No
012	RENO-DIP	DIATRIZOATE MEGLUMINE	INJECTABLE;INJECTION	30%	No	No
016	RENO-60	DIATRIZOATE MEGLUMINE	INJECTABLE;INJECTION	60%	No	No
017	DIATRIZOATE MEGLUMINE	DIATRIZOATE MEGLUMINE	INJECTABLE;INJECTION	76%	No	No
018	CYSTOGRAFIN	DIATRIZOATE MEGLUMINE	SOLUTION;URETHRAL	30%	Yes	No
019	RENOVIST II	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	INJECTABLE;INJECTION	28.5%;29.1%	No	No
020	RENOVIST	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	INJECTABLE;INJECTION	34.3%;35%	No	No
021	RENO-30	DIATRIZOATE MEGLUMINE	SOLUTION;URETERAL	30%	No	No
022	CYSTOGRAFIN DILUTE	DIATRIZOATE MEGLUMINE	SOLUTION;URETHRAL	18%	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 10 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N010040-001	RENOGRAFIN-76	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	66%;10%	INJECTABLE / INJECTION	RLD, Approved before 1982
N010040-006	RENOGRAFIN-60	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	52%;8%	INJECTABLE / INJECTION	Approved before 1982
N010040-012	RENO-DIP	DIATRIZOATE MEGLUMINE	30%	INJECTABLE / INJECTION	Approved before 1982
N010040-016	RENO-60	DIATRIZOATE MEGLUMINE	60%	INJECTABLE / INJECTION	Approved before 1982
N010040-017	DIATRIZOATE MEGLUMINE	DIATRIZOATE MEGLUMINE	76%	INJECTABLE / INJECTION	Approved before 1982
N010040-018	CYSTOGRAFIN	DIATRIZOATE MEGLUMINE	30%	SOLUTION / URETHRAL	RLD, Approved before 1982
N010040-019	RENOVIST II	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	28.5%;29.1%	INJECTABLE / INJECTION	Approved before 1982
N010040-020	RENOVIST	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	34.3%;35%	INJECTABLE / INJECTION	Approved before 1982
N010040-021	RENO-30	DIATRIZOATE MEGLUMINE	30%	SOLUTION / URETERAL	Approved before 1982
N010040-022	CYSTOGRAFIN DILUTE	DIATRIZOATE MEGLUMINE	18%	SOLUTION / URETHRAL	RLD	1982-11-09

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 11 · 410 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	N010040-001	RENOGRAFIN-76	66%;10%	INJECTABLE / INJECTION	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010040-006	RENOGRAFIN-60	52%;8%	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010040-012	RENO-DIP	30%	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010040-016	RENO-60	60%	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010040-017	DIATRIZOATE MEGLUMINE	76%	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010040-018	CYSTOGRAFIN	30%	SOLUTION / URETHRAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010040-019	RENOVIST II	28.5%;29.1%	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010040-020	RENOVIST	34.3%;35%	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010040-021	RENO-30	30%	SOLUTION / URETERAL	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010040-022	CYSTOGRAFIN DILUTE	18%	SOLUTION / URETHRAL	RLD	1982-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010040-001	RENOGRAFIN-76	66%;10%	INJECTABLE / INJECTION	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010040-006	RENOGRAFIN-60	52%;8%	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010040-012	RENO-DIP	30%	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010040-016	RENO-60	60%	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010040-017	DIATRIZOATE MEGLUMINE	76%	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010040-018	CYSTOGRAFIN	30%	SOLUTION / URETHRAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010040-019	RENOVIST II	28.5%;29.1%	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010040-020	RENOVIST	34.3%;35%	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010040-021	RENO-30	30%	SOLUTION / URETERAL	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010040-022	CYSTOGRAFIN DILUTE	18%	SOLUTION / URETHRAL	RLD	1982-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N010040-001	RENOGRAFIN-76	66%;10%	INJECTABLE / INJECTION	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010040-006	RENOGRAFIN-60	52%;8%	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010040-012	RENO-DIP	30%	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010040-016	RENO-60	60%	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010040-017	DIATRIZOATE MEGLUMINE	76%	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010040-018	CYSTOGRAFIN	30%	SOLUTION / URETHRAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010040-019	RENOVIST II	28.5%;29.1%	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010040-020	RENOVIST	34.3%;35%	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010040-021	RENO-30	30%	SOLUTION / URETERAL	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010040-022	CYSTOGRAFIN DILUTE	18%	SOLUTION / URETHRAL	RLD	1982-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010040-001	RENOGRAFIN-76	66%;10%	INJECTABLE / INJECTION	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010040-006	RENOGRAFIN-60	52%;8%	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010040-012	RENO-DIP	30%	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010040-016	RENO-60	60%	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010040-017	DIATRIZOATE MEGLUMINE	76%	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010040-018	CYSTOGRAFIN	30%	SOLUTION / URETHRAL	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010040-019	RENOVIST II	28.5%;29.1%	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010040-020	RENOVIST	34.3%;35%	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010040-021	RENO-30	30%	SOLUTION / URETERAL	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010040-022	CYSTOGRAFIN DILUTE	18%	SOLUTION / URETHRAL	RLD	1982-11-09	`fd3edfee7708…`

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
Cystografin Dilute	DIATRIZOATE MEGLUMINE	BRACCO DIAGNOSTICS INC	e56882fa-4a30-43b1-bb6b-f7d4a4101c4e	2025-11-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 010040 application number: NDA010040 ndc (product): 0270-1410
Cystografin	DIATRIZOATE MEGLUMINE	BRACCO DIAGNOSTICS INC	7496d736-9f7d-4136-ad5d-b24c7803c21b	2025-11-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 010040 application number: NDA010040 ndc (product): 0270-0149

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0270-0149	Cystografin	diatrizoate meglumine	BRACCO DIAGNOSTICS INC	NDA	Current
0270-1410	Cystografin Dilute	diatrizoate meglumine	BRACCO DIAGNOSTICS INC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10735	SUPPL	2015-07-13
11886	SUPPL	2015-07-10
196	SUPPL	2003-10-01
11885	SUPPL	2002-10-23