Prescription drug · NDA
Pulmicort Flexhaler (Budesonide) NDC 85612-011
Budesonide 180 ug/1 · Aerosol, Powder · Respiratory (Inhalation) · Rubicon Holdings Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85612-011-01 | 8561200110185612001101 | 1 INHALER in 1 CARTON (85612-011-01) / 120 AEROSOL, POWDER in 1 INHALERMarketed from Aug 14, 2025 |
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)
- Pulmicort FlexhalerSuffix: FLEXHALER
- Generic name (nonproprietary)
- budesonide
- Active ingredients
- Budesonide — 180 ug/1
- Dosage form
- Aerosol, Powder
- Route
- Respiratory (Inhalation)
- Labeler
- Rubicon Holdings Inc.NDC labeler code 85612
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021949
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 85612-011_3dff07f9-e653-e2a1-e063-6294a90a92ffSPL ID 3dff07f9-e653-e2a1-e063-6294a90a92ffSPL set ID ae1105cd-69fc-4c15-937f-c535304341c2RxCUI 966522, 966524, 966527, 966529UNII Q3OKS62Q6XUPC 0385612011010
- 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
N485612001101followed by a unit qualifier and the quantityPackage 85612-0011-01. 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 FLEXHALER is a corticosteroid indicated for: Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older ( 1 ) Limitations of Use: Not indicated for the relief of acute bronchospasm ( 1 ) 1.1 Treatment of Asthma PULMICORT FLEXHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in patients six years of age or older. Limitations of Use: PULMICORT FLEXHALER is NOT indicated for the relief of acute bronchospasm.
Excerpt only. Read the full label for complete information.
About NDC 85612-011
- What is NDC 85612-011?
- 85612-011 is the product NDC for Pulmicort Flexhaler (budesonide), Budesonide 180 ug/1 aerosol, powder, listed with the FDA by Rubicon Holdings Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pulmicort Flexhaler (Budesonide).
- What is the active ingredient?
- Budesonide.
- Who is the labeler?
- Rubicon Holdings Inc., NDC labeler code 85612. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pulmicort Flexhaler?
- 6 other product NDCs are listed under this name. See all Pulmicort Flexhaler NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pulmicort Flexhaler products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pulmicort Flexhalerbudesonide | Budesonide 90 ug/1 | Aerosol, PowderRespiratory (Inhalation) | Rubicon Holdings Inc. | 85612-010 | 85612-0010-01 |
| Pulmicort Flexhalerbudesonide | Budesonide 180 ug/1 | Aerosol, PowderRespiratory (Inhalation) | A-S Medication Solutions | 50090-7867 | 50090-7867-00 |
| Pulmicort Flexhalerbudesonide | Budesonide 180 ug/1 | Aerosol, PowderRespiratory (Inhalation) | A-S Medication Solutions | 50090-2239 | 50090-2239-00 |
| Pulmicort Flexhalerbudesonide | Budesonide 180 ug/1 | Aerosol, PowderRespiratory (Inhalation) | A-S Medication Solutions | 50090-6796 | 50090-6796-00 |
| Pulmicort Flexhalerbudesonide | Budesonide 90 ug/1 | Aerosol, PowderRespiratory (Inhalation) | H2-Pharma LLC | 61269-509 | 61269-0509-06 |
| Pulmicort Flexhalerbudesonide | Budesonide 180 ug/1 | Aerosol, PowderRespiratory (Inhalation) | H2-Pharma LLC | 61269-518 | 61269-0518-12 |
Other NDCs under NDA 021949
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 Flexhalerbudesonide | Budesonide 180 ug/1 | Aerosol, PowderRespiratory (Inhalation) | A-S Medication Solutions | 50090-2239 |
| Pulmicort Flexhalerbudesonide | Budesonide 180 ug/1 | Aerosol, PowderRespiratory (Inhalation) | A-S Medication Solutions | 50090-6796 |
| Pulmicort Flexhalerbudesonide | Budesonide 180 ug/1 | Aerosol, PowderRespiratory (Inhalation) | A-S Medication Solutions | 50090-7867 |
| Pulmicort Flexhalerbudesonide | Budesonide 90 ug/1 | Aerosol, PowderRespiratory (Inhalation) | H2-Pharma LLC | 61269-509 |
| Pulmicort Flexhalerbudesonide | Budesonide 180 ug/1 | Aerosol, PowderRespiratory (Inhalation) | H2-Pharma LLC | 61269-518 |
| Pulmicort Flexhalerbudesonide | Budesonide 90 ug/1 | Aerosol, PowderRespiratory (Inhalation) | Rubicon Holdings Inc. | 85612-010 |