NDC 50242-100

Pulmozyme

Dornase Alfa

Pulmozyme is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Dornase Alfa.

• Product ID: 50242-100_81fdca2f-b602-4513-b449-f31f76f4298f
• NDC: 50242-100
• Product Type: Human Prescription Drug
• Proprietary Name: Pulmozyme
• Generic Name: Dornase Alfa
• Dosage Form: Solution
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 1993-12-30
• Marketing Category: BLA / BLA
• Application Number: BLA103532
• Labeler Name: Genentech, Inc.
• Substance Name: DORNASE ALFA
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Decreased Respiratory Secretion Viscosity [PE], Deoxyribonuclease I [CS], Recombinant Human Deoxyribonuclease 1 [EPC], Recombinant Proteins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 50242-100-40

5 POUCH in 1 CARTON (50242-100-40) > 6 AMPULE in 1 POUCH > 2.5 mL in 1 AMPULE

• Marketing Start Date: 1993-12-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50242-100-40 [50242010040]

Pulmozyme SOLUTION

• Marketing Category: BLA
• Application Number: BLA103532
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1993-12-30

Drug Details

Active Ingredients

Ingredient	Strength
DORNASE ALFA	1 mg/mL

OpenFDA Data

• SPL SET ID: d8c78a7e-ff99-48f3-8952-643ec2ea0f86
• Manufacturer:
  • Genentech, Inc.
• UNII:
  • 953A26OA1Y
• RxNorm Concept Unique ID - RxCUI:
  • 310014
  • 205532

Pharmacological Class

• Decreased Respiratory Secretion Viscosity [PE]
• Deoxyribonuclease I [CS]
• Recombinant Human Deoxyribonuclease 1 [EPC]
• Recombinant Proteins [CS]
• Decreased Respiratory Secretion Viscosity [PE]
• Deoxyribonuclease I [CS]
• Recombinant Human Deoxyribonuclease 1 [EPC]
• Recombinant Proteins [CS]

Medicade Reported Pricing

50242010040 PULMOZYME 1 MG/ML AMPUL

Pricing Unit: ML | Drug Type: