Prescription drug · BLA
Pulmozyme (dornase alfa) NDC 50242-100
Dornase alfa 1 mg/mL · Solution · Respiratory (Inhalation) · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-100-40 | 50242010040 | 5 POUCH in 1 CARTON (50242-100-40) / 6 AMPULE in 1 POUCH (50242-100-39) / 2.5 mL in 1 AMPULEMarketed from Dec 30, 1993 |
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)
- Pulmozyme
- Generic name (nonproprietary)
- dornase alfa
- Active ingredients
- Dornase alfa — 1 mg/mL
- Dosage form
- Solution
- Route
- Respiratory (Inhalation)
- Labeler
- Genentech, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103532
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Respiratory Secretion Viscosity (Physiologic effect)Deoxyribonuclease I (Chemical structure)Recombinant Proteins (Chemical structure)
- Identifiers
- Product ID 50242-100_71192c41-f7be-44b0-b232-1f74369239a0SPL ID 71192c41-f7be-44b0-b232-1f74369239a0SPL set ID d8c78a7e-ff99-48f3-8952-643ec2ea0f86RxCUI 205532, 310014UNII 953A26OA1Y
- Pharmacologic class
- Recombinant Human Deoxyribonuclease 1
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
N450242010040followed by a unit qualifier and the quantityPackage 50242-0100-40. 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)
PULMOZYME ® is indicated, in conjunction with standard therapies, for the management of pediatric and adult patients with cystic fibrosis (CF) to improve pulmonary function. In CF patients with an FVC ≥ 40% of predicted, daily administration of PULMOZYME has also been shown to reduce the risk of respiratory tract infections requiring parenteral antibiotics. PULMOZYME is a recombinant DNase enzyme indicated in conjunction with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function. ( 1 )
Excerpt only. Read the full label for complete information.