Budesonide Suspension
NDC Package 0093-6816-76
Package Information
Budesonide suspension is budesonide is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. This formulation utilizes a suspension delivery system. Marketed by Teva Pharmaceuticals Usa, Inc., this product is identified by NDC 0093-6816 and is authorized under FDA application ANDA077519.
Identification & Billing
- RxCUI: 349094 - budesonide 0.25 MG in 2 ML Inhalation Suspension
- RxCUI: 349094 - budesonide 0.125 MG/ML Inhalation Suspension
- RxCUI: 349094 - budesonide 0.25 MG per 2 ML Inhalation Suspension
- RxCUI: 351109 - budesonide 0.5 MG in 2 ML Inhalation Suspension
- RxCUI: 351109 - budesonide 0.25 MG/ML Inhalation Suspension
Clinical Specifications
- Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
- Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Regulatory & Marketing
Hierarchy Structure
- 0093 - Teva Pharmaceuticals Usa, Inc.
- 0093-6816 - Budesonide
- 0093-6816-76 - 2 POUCH in 1 CARTON / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE
- 0093-6816 - Budesonide
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
* Please review the full disclaimer at the bottom of this page.
Other Available Packages
The following commercial packages are registered under the same Product NDC (0093-6816). Click a package code to view its specific billing and regulatory data.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0093-6816-76 identifies a specific commercial package of 2 pouch in 1 carton / 5 vial, single-dose in 1 pouch / 2 ml in 1 vial, single-dose of Budesonide, a human prescription drug labeled by Teva Pharmaceuticals Usa, Inc.. This suspension is formulated for respiratory (inhalation) use and contains budesonide as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Teva Pharmaceuticals Usa, Inc. on January 11, 2019. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
Budesonide is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma. This medication belongs to a class of drugs known as corticosteroids. It works directly in the lungs to make breathing easier by reducing the irritation and swelling of the airways. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler as prescribed.
How is this Teva Pharmaceuticals Usa, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00093681676. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.
