Labeler · US market

BTG International Inc

BTG International Inc is a US drug labeler with US FDA registrations covering 8 drug concepts (8 currently active) across 10 packages. It is currently the only active US supplier of 5 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes50633

Active drugs8

Registrations10 active / 10

Packages10

Sole supplier of5 drugs

Portfolio8 drugs · US

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

Drug	Type	NDCs	Packages	Status
Uridine Triacetate granule	rx	2	3	SUPPLYING
Potassium Iodide tablet	otc	2	2	SUPPLYING
Hydroxocobalamin injection, powder, lyophilized, for solution	rx	1	1	SUPPLYING
Ovine Crotalidae Venoms Immune Fab injection, powder, lyophilized, for solution	other	1	1	SUPPLYING
Glucarpidase injection, powder, for solution	rx	1	1	SUPPLYING
Ovine Digoxin Immune Fab injection, powder, lyophilized, for solution	other	1	1	SUPPLYING
Iloprost injection, solution	rx	1	1	SUPPLYING
Naxitamab injection	rx	1	0	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 codes50633
Filing names1
Drugs (active)8
Drugs (all time)8
US registrations10
Packages10

Recent events

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

Nov 4, 2024
SHORTAGEDrug shortage: Hydroxocobalamin Injection (BTG International Inc.)

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.