Prescription drug · ANDA
Budesonide NDC 62135-822
Budesonide .25 mg/2mL · Suspension · Respiratory (Inhalation) · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-822-84 | 62135082284 | 6 POUCH in 1 CARTON (62135-822-84) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULEMarketed from Jan 30, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — .25 mg/2mL
- Dosage form
- Suspension
- Route
- Respiratory (Inhalation)
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078202
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 62135-822_10690463-7fb3-af77-e063-6294a90ad2deSPL ID 10690463-7fb3-af77-e063-6294a90ad2deSPL set ID 374013c9-18c9-4419-b9fb-9bc5c765688eRxCUI 349094, 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
N462135082284followed by a unit qualifier and the quantityPackage 62135-0822-84. 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 inhalation suspension 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 078202
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 | InhalantRespiratory (Inhalation) | Rising Pharma Holdings, Inc. | 64980-638 |
| Budesonide | Budesonide .5 mg/2mL | InhalantRespiratory (Inhalation) | Rising Pharma Holdings, Inc. | 64980-639 |
| Budesonide | Budesonide .5 mg/2mL | SuspensionRespiratory (Inhalation) | Chartwell RX, LLC | 62135-823 |
| Budesonide | Budesonide .25 mg/2mL | InhalantRespiratory (Inhalation) | A-S Medication Solutions | 50090-7173 |
| Budesonide | Budesonide .25 mg/2mL | InhalantRespiratory (Inhalation) | Nephron Pharmaceuticals Corporation | 0487-9601 |
| Budesonide | Budesonide .5 mg/2mL | InhalantRespiratory (Inhalation) | Nephron Pharmaceuticals Corporation | 0487-9701 |