Labeler · US market

ICU Medical Inc.

ICU Medical Inc. is a US drug labeler with US FDA registrations covering 25 drug concepts (25 currently active) across 95 packages. It is currently the only active US supplier of 9 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes0990

Active drugs25

Registrations53 active / 53

Packages95

Sole supplier of9 drugs

Portfolio25 drugs · US

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

Drug	Type	NDCs	Packages	Status
Sodium Chloride injection, solution	rx	4	16	SUPPLYING
Dextrose Monohydrate injection, solution	rx	4	15	SUPPLYING
Dextrose Monohydrate And Sodium Chloride injection, solution	rx	4	10	SUPPLYING
Dextrose Monohydrate, Sodium Chloride, And Potassium Chloride injection, solution	rx	7	8	SUPPLYING
Dextrose injection, solution	rx	5	5	SUPPLYING
Potassium Chloride injection, solution	rx	3	5	SUPPLYING
Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-Acetyltyrosine, And Glycine injection, solution	rx	4	4	SUPPLYING
Sodium Chloride irrigant	rx	1	3	SUPPLYING
Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride injection, solution	rx	1	3	SUPPLYING
Water irrigant	rx	1	3	SUPPLYING
Sodium Chloride And Potassium Chloride injection, solution	rx	3	3	SUPPLYING
Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride injection, solution	rx	2	3	SUPPLYING
Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride And Dextrose Monohydrate injection, solution	rx	1	2	SUPPLYING
Dextrose Monohydrate, Sodium Lactate, Potassium Chloride, Magnesium Chloride, Potassium Phosphate, Monobasic, And Sodium Phosphate, Monobasic, Monohydrate injection, solution	rx	1	2	SUPPLYING
Water injection, solution	rx	2	2	SUPPLYING
Mannitol injection, solution	rx	1	2	SUPPLYING
Sodium Chloride, Potassium Chloride, And Calcium Chloride injection, solution	rx	1	1	SUPPLYING
Dextrose Monohydrate And Potassium Chloride Injection, Solution injection, solution	rx	1	1	SUPPLYING
Sorbitol And Mannitol irrigant	rx	1	1	SUPPLYING
Dextrose Monohydrate injection, solution, concentrate	rx	1	1	SUPPLYING
Potassium Chloride, Sodium Chloride, Calcium Chloride, Sodium Lactate, And Dextrose Monohydrate injection, solution	rx	1	1	SUPPLYING
Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride irrigant	rx	1	1	SUPPLYING
Dextrose Monohydrate, Sodium Chloride, Potassium Acetate, And Magnesium Acetate injection, solution	rx	1	1	SUPPLYING
Glycine irrigant	rx	1	1	SUPPLYING
Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride injection, 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 codes0990
Filing names1
Drugs (active)25
Drugs (all time)25
US registrations53
Packages95

Recent events

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

Oct 29, 2025
RECALLRecall (Class I): POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical…
Oct 29, 2025
RECALLRecall (Class I): POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical,…
Oct 27, 2025
RECALLRecall (Class II): 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-79…
Feb 13, 2025
RECALLRecall (Class I): POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., La…
Feb 13, 2025
RECALLRecall (Class I): POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest,…
Oct 11, 2024
SHORTAGEDrug shortage: Dextrose Monohydrate 70% Injection (Otsuka ICU Medical LLC)
Nov 9, 2022
RECALLRecall (Class II): 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, …
Mar 1, 2022
SHORTAGEDrug shortage: Dextrose Monohydrate 10% Injection (Otsuka ICU Medical LLC)

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.