Drugplain

Budesonide Inhalation .25 mg/2mL

Budesonide · SUSPENSION · Preferred Pharmaceuticals Inc.

6 Recalls on Record
Plain English

Budesonide Inhalation is a suspension containing budesonide at .25 mg/2mL, taken respiratory (inhalation). Manufactured by Preferred Pharmaceuticals Inc..

Key Facts

Brand Name
Budesonide Inhalation
Generic Name
Budesonide
NDC Code (Product)
68788-8429
Manufacturer
Preferred Pharmaceuticals Inc.
Strength
.25 mg/2mL
Dosage Form
SUSPENSION
Route
RESPIRATORY (INHALATION)
Marketing Status
Application #
ANDA078404
Drug Class
Corticosteroid [EPC]
Marketing Start
04/24/2023

Recall History

6 Recalls on Record
Class II05/29/2026

SUN PHARMACEUTICAL INDUSTRIES INC

Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution

OngoingVoluntary: Firm initiated
Class II05/14/2025

AsttraZeneca Pharmaceuticals LP

Defective delivery system

OngoingVoluntary: Firm initiated
Class II06/30/2025

Cipla USA, Inc.

Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.

OngoingVoluntary: Firm initiated
Class III01/11/2013

AstraZeneca LP

Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.

TerminatedVoluntary: Firm initiated
Class II09/15/2022

CIPLA

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class III01/11/2013

AstraZeneca LP

Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is Budesonide Inhalation used for?

Budesonide Inhalation contains Budesonide. It is a suspension taken respiratory (inhalation). Consult your doctor for specific uses.

Is Budesonide Inhalation a controlled substance?

Budesonide Inhalation is not classified as a controlled substance by the DEA.

What is the generic name for Budesonide Inhalation?

The generic name for Budesonide Inhalation is Budesonide. There are 11 other brand versions of Budesonide.

What is the NDC code for Budesonide Inhalation .25 mg/2mL?

The NDC (National Drug Code) for Budesonide Inhalation .25 mg/2mL is 68788-8429, listed by Preferred Pharmaceuticals Inc..

Product NDC

68788-8429

Package NDC

68788-8429-3

Other Budesonide Inhalation Dosages

Other Budesonide Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)