Home NDC 0270-0149 Cystografin
Product NDC 0270-0149
11-digit product format 002700149
Labeler code 0270
Product ID 0270-0149_6b067ea9-50b4-0ec7-1f1c-e07b00faced4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diatrizoate meglumine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler BRACCO DIAGNOSTICS INC
Application NDA010040
Marketing category NDA
Marketing start 1970-11-03
Substance DIATRIZOATE MEGLUMINE
Active strength 300 mg/mL
Pharmacologic classes Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 TE codes 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 Product TE source text 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…
Additional Listing Data#
Finished product Yes
Brand name base Cystografin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIATRIZOATE MEGLUMINE 300 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3X9MR4N98U Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0270-0149-57 Cystografin 10 in 1 PACKAGE INJECTION, SOLUTION 10 7 0270-0149-57 Cystografin 300 mL in 1 BOTTLE INJECTION, SOLUTION 300 7 0270-0149-60 Cystografin 10 in 1 PACKAGE INJECTION, SOLUTION 10 7 0270-0149-60 Cystografin 100 mL in 1 BOTTLE INJECTION, SOLUTION 100 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0270-0149 CYSTOGRAFIN (DIATRIZOATE MEGLUMINE) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 6 Current NDC, Legacy NDC, 4 package rows 20181010_7496d736-9f7d-4136-ad5d-b24c7803c21b.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0270-0149-57 00270014957 10 BOTTLE in 1 PACKAGE (0270-0149-57) / 300 mL in 1 BOTTLE 10 bottle 1970-11-03 0000-00-00 No No Current 0270-0149-60 00270014960 10 BOTTLE in 1 PACKAGE (0270-0149-60) / 100 mL in 1 BOTTLE 10 bottle 1970-11-03 0000-00-00 No No Current