Prescription drug · ANDA
Budesonide NDC 50090-6586
Budesonide .5 mg/2mL · Suspension · Respiratory (Inhalation) · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6586-0 | 50090658600 | 6 POUCH in 1 CARTON (50090-6586-0) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULEMarketed from Aug 9, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Budesonide
- Generic name (nonproprietary)
- budesonide
- Active ingredients
- Budesonide — .5 mg/2mL
- Dosage form
- Suspension
- Route
- Respiratory (Inhalation)
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211922
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 50090-6586_6cd18e8a-1a34-4e9e-914c-198ef79a8a83SPL ID 6cd18e8a-1a34-4e9e-914c-198ef79a8a83SPL set ID 4a7d97e0-36f7-4ac9-8f9b-4c3aac568c2bRxCUI 351109UNII Q3OKS62Q6X
- Pharmacologic class
- Corticosteroid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N450090658600followed by a unit qualifier and the quantityPackage 50090-6586-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Budesonide is an inhaled corticosteroid indicated for: Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age (1) Limitations of Use: Not indicated for the relief of acute bronchospasm (1) 1.1 Maintenance Treatment of Asthma Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use: Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211922
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Budesonide | Budesonide .25 mg/2mL | SuspensionRespiratory (Inhalation) | American Health Packaging | 60687-889 |
| Budesonide | Budesonide .5 mg/2mL | SuspensionRespiratory (Inhalation) | Sun Pharmaceutical Industries, Inc. | 47335-632 |
| Budesonide | Budesonide .25 mg/2mL | SuspensionRespiratory (Inhalation) | Sun Pharmaceutical Industries, Inc. | 47335-631 |
| Budesonide | Budesonide 1 mg/2mL | SuspensionRespiratory (Inhalation) | Sun Pharmaceutical Industries, Inc. | 47335-633 |
| Budesonide | Budesonide .25 mg/2mL | SuspensionRespiratory (Inhalation) | A-S Medication Solutions | 50090-6590 |