Labeler · US market

Accord BioPharma Inc.

Accord BioPharma Inc. is a US drug labeler with US FDA registrations covering 8 drug concepts (8 currently active) across 18 packages. It is currently the only active US supplier of 6 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes69448

Active drugs8

Registrations16 active / 16

Packages18

Sole supplier of6 drugs

Portfolio8 drugs · US

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

Drug	Type	NDCs	Packages	Status
Filgrastim-Laha injection, solution	rx	2	4	SUPPLYING
Pegfilgrastim-Cbqv injection, solution	rx	3	3	SUPPLYING
Trastuzumab-Strf injection, powder, lyophilized, for solution	rx	2	2	SUPPLYING
Denosumab-Desu injection	rx	2	2	SUPPLYING
Leuprolide injection, emulsion	rx	2	2	SUPPLYING
Mitomycin injection, powder, lyophilized, for solution	rx	2	2	SUPPLYING
Ustekinumab-Srlf injection	rx	2	2	SUPPLYING
Ustekinumab-Srlf injection	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 codes69448
Filing names1
Drugs (active)8
Drugs (all time)8
US registrations16
Packages18

Recent events

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

Jun 10, 2026
RECALLRecall (Class II): IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPha…

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.