Labeler · US market

Bracco Diagnostics Inc

Bracco Diagnostics Inc is a US drug labeler with US FDA registrations covering 15 drug concepts (15 currently active) across 71 packages. It is currently the only active US supplier of 10 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes0270

Active drugs15

Registrations31 active / 31

Packages71

Sole supplier of10 drugs

Portfolio15 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Iomeprol Injection injection, solution	rx	7	14	SUPPLYING
Iopamidol injection, solution	rx	4	14	SUPPLYING
Gadopiclenol injection	rx	5	13	SUPPLYING
Gadobenate Dimeglumine injection, solution	rx	2	6	SUPPLYING
Gadoteridol injection, solution	rx	1	6	SUPPLYING
Iomeprol Injection injection, solution	rx	2	4	SUPPLYING
Sulfur Hexafluoride kit	rx	1	2	SUPPLYING
Diatrizoate Meglumine And Diatrizoate Sodium liquid	rx	1	2	SUPPLYING
Iopamidol injection, solution	rx	2	2	SUPPLYING
Sulfur Hexafluoride injection, powder, lyophilized, for suspension	rx	1	2	SUPPLYING
Diatrizoate Meglumine injection, solution	rx	1	2	SUPPLYING
Diatrizoate Meglumine injection, solution	rx	1	1	SUPPLYING
Rubidium Chloride Rb-82 injection, solution	rx	1	1	SUPPLYING
Sincalide injection, powder, lyophilized, for solution	rx	1	1	SUPPLYING
Mebrofenin injection, powder, lyophilized, for solution	rx	1	1	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

At a glance

TypeLabeler
Labeler codes0270
Filing names1
Drugs (active)15
Drugs (all time)15
US registrations31
Packages71

Recent events

Shortages, recalls, and registration changes across all filing names.

Apr 13, 2022
RECALLRecall (Class II): Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP), packaged in: Twenty-four 30 mL single dose bo…
Apr 13, 2022
RECALLRecall (Class II): Kinevac (Sincalide for Injection), 5mcg per vial, 10 vials per box, Rx only, MFG: Bracco Diagnostics Inc., NDC 0270-055…
Mar 8, 2018
RECALLRecall (Class II): E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-E…
Dec 16, 2013
RECALLRecall (Class III): VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a …
Jul 19, 2013
RECALLRecall (Class III): Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by…
Jun 21, 2013
RECALLRecall (Class II): Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle,…
Aug 14, 2012
RECALLRecall (Class III): Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, F…
Jun 1, 2012
RECALLRecall (Class II): CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.