Prescription drug · NDA
Pulmicort Respules (budesonide) NDC 0186-1989
Budesonide .5 mg/2mL · Suspension · Respiratory (Inhalation) · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0186-1989-04 | 00186198904 | 6 POUCH in 1 CARTON (0186-1989-04) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULEMarketed from Sep 8, 2000 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Pulmicort Respules
- Generic name (nonproprietary)
- budesonide
- Active ingredients
- Budesonide — .5 mg/2mL
- Dosage form
- Suspension
- Route
- Respiratory (Inhalation)
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020929
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0186-1989_76a8044c-b6f4-4da4-b855-a281fdca66b4SPL ID 76a8044c-b6f4-4da4-b855-a281fdca66b4SPL set ID 33cd9834-76df-4f26-3fa2-aab6b9eee8f2RxCUI 252559, 349094, 351109, 616817, 616819, 616830UNII 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
N400186198904followed by a unit qualifier and the quantityPackage 00186-1989-04. 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)
PULMICORT RESPULES ® 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 PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use : • PULMICORT RESPULES is NOT indicated for the relief of acute bronchospasm.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020929
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 |
|---|---|---|---|---|
| Pulmicort Respulesbudesonide | Budesonide .25 mg/2mL | SuspensionRespiratory (Inhalation) | AstraZeneca Pharmaceuticals LP | 0186-1988 |
| Pulmicort Respulesbudesonide | Budesonide 1 mg/2mL | SuspensionRespiratory (Inhalation) | AstraZeneca Pharmaceuticals LP | 0186-1990 |