Labeler · US market

XGen Pharmaceuticals DJB, Inc.

XGen Pharmaceuticals DJB, Inc. is a US drug labeler with US FDA registrations covering 24 drug concepts (23 currently active) across 35 packages. It is currently the only active US supplier of 4 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes39822

Active drugs23

Registrations31 active / 32

Packages35

Sole supplier of4 drugs

Portfolio24 drugs · US

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

Drug	Type	NDCs	Packages	Status
Cyclophosphamide injection, powder, lyophilized, for solution	rx	3	3	SUPPLYING
Promethazine Hydrochloride injection, solution	rx	2	2	SUPPLYING
Vancomycin Hydrochloride injection, powder, lyophilized, for solution	rx	2	2	SUPPLYING
Nelarabine injection	rx	1	2	SUPPLYING
Desmopressin Acetate injection, solution	rx	2	2	SUPPLYING
Lincomycin Hydrochloride injection, solution	rx	2	2	SUPPLYING
Neomycin And Polymyxin B Sulfates solution	rx	2	2	SUPPLYING
Tobramycin injection, powder, lyophilized, for solution	rx	1	2	SUPPLYING
Rocuronium Bromide solution	rx	1	2	SUPPLYING
Clonidine injection, solution	rx	2	2	SUPPLYING
Dactinomycin injection, powder, lyophilized, for solution	rx	1	1	SUPPLYING
Folic Acid injection, solution	rx	1	1	SUPPLYING
Pentamidine Isethionate inhalant	rx	1	1	SUPPLYING
Amphotericin B injection, powder, lyophilized, for solution	rx	1	1	SUPPLYING
Pentamidine Isethionate injection, powder, lyophilized, for solution	rx	1	1	SUPPLYING
Ibuprofen Lysine solution	rx	1	1	SUPPLYING
Streptomycin injection, powder, lyophilized, for solution	rx	1	1	SUPPLYING
Alcohol injection, solution	rx	1	1	SUPPLYING
Acetazolamide injection, powder, lyophilized, for solution	rx	1	1	SUPPLYING
Tranexamic Acid injection, solution	rx	1	1	SUPPLYING
Eribulin Mesylate injection	rx	1	1	SUPPLYING
Liothyronine Sodium injection, solution	rx	1	1	SUPPLYING
Olanzapine injection, powder, for solution	rx	1	1	SUPPLYING
Edaravone injection, solution	rx	1	1	DISCONTINUED

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 codes39822
Filing names1
Drugs (active)23
Drugs (all time)24
US registrations32
Packages35

Recent events

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

Mar 26, 2026
RESOLVEDShortage resolved: Lincomycin Hydrochloride Injection (XGen Pharmaceuticals DJB, Inc.)
Mar 26, 2026
SHORTAGEDrug shortage: Lincomycin Hydrochloride Injection (XGen Pharmaceuticals DJB, Inc.)
Mar 23, 2026
RESOLVEDShortage resolved: Pentamidine Isethionate Injection (XGen Pharmaceuticals DJB, Inc.)
Mar 23, 2026
SHORTAGEDrug shortage: Pentamidine Isethionate Injection (XGen Pharmaceuticals DJB, Inc.)
Nov 21, 2023
SHORTAGEDrug shortage: Promethazine Hydrochloride Injection (XGen Pharmaceuticals DJB, Inc.)
Feb 15, 2023
SHORTAGEDrug shortage: Rocuronium Bromide Injection (XGen Pharmaceuticals DJB, Inc.)
Mar 29, 2019
RECALLRecall (Class III): Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceu…
Feb 8, 2017
RECALLRecall (Class I): Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Singl…

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.