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NDC 55154-4849-05 Budesonide 0.5 mg/2mL Details

Budesonide 0.5 mg/2mL

Budesonide is a RESPIRATORY (INHALATION) SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cardinal Health 107, LLC. The primary component is BUDESONIDE.

MedlinePlus Drug Summary

Budesonide is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma. Budesonide powder for oral inhalation (Pulmicort Flexhaler) is used in adults and children 6 years of age and older. Budesonide suspension (liquid) for oral inhalation (Pulmicort Respules) is used in children 12 months to 8 years of age. Budesonide belongs to a class of medications called corticosteroids. It works by decreasing swelling and irritation in the airways to allow for easier breathing.

Related Packages: 55154-4849-05
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Budesonide Oral Inhalation

Product Information

NDC	55154-4849
Product ID	55154-4849_5721bdd7-beec-4d4d-942a-0460fedc9ced
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Budesonide
Proprietary Name Suffix	n/a
Non-Proprietary Name	Budesonide
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SUSPENSION
Route	RESPIRATORY (INHALATION)
Active Ingredient Strength	0.5
Active Ingredient Units	mg/2mL
Substance Name	BUDESONIDE
Labeler Name	Cardinal Health 107, LLC
Pharmaceutical Class	Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA077519
Listing Certified Through	2024-12-31

Package

NDC 55154-4849-05 (55154484905)

Pricing Information	N/A
NDC Package Code	55154-4849-5
Billing NDC	55154484905
Package	5 VIAL, SINGLE-DOSE in 1 BAG (55154-4849-5) / 2 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date	2019-01-11
NDC Exclude Flag	N