pulmozyme

Generic: dornase alfa

Labeler: genentech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name pulmozyme
Generic Name dornase alfa
Labeler genentech, inc.
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

dornase alfa 1 mg/mL

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-100
Product ID 50242-100_71192c41-f7be-44b0-b232-1f74369239a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103532
Listing Expiration 2026-12-31
Marketing Start 1993-12-30

Pharmacologic Class

Established (EPC)
recombinant human deoxyribonuclease 1 [epc]
Chemical Structure
deoxyribonuclease i [cs] recombinant proteins [cs]
Physiologic Effect
decreased respiratory secretion viscosity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242100
Hyphenated Format 50242-100

Supplemental Identifiers

RxCUI
205532 310014
UNII
953A26OA1Y
NUI
N0000008867 M0006007 N0000175958 M0018641

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pulmozyme (source: ndc)
Generic Name dornase alfa (source: ndc)
Application Number BLA103532 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 5 POUCH in 1 CARTON (50242-100-40) / 6 AMPULE in 1 POUCH (50242-100-39) / 2.5 mL in 1 AMPULE
source: ndc

Packages (1)

50242-100-40 5 POUCH in 1 CARTON (50242-100-40) / 6 AMPULE in 1 POUCH (50242-100-39) / 2.5 mL in 1 AMPULE

Ingredients (1)

dornase alfa (1 mg/mL)

Linked Drug Pages (1)

Pulmozyme ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "71192c41-f7be-44b0-b232-1f74369239a0", "openfda": {"nui": ["N0000008867", "M0006007", "N0000175958", "M0018641"], "unii": ["953A26OA1Y"], "rxcui": ["205532", "310014"], "spl_set_id": ["d8c78a7e-ff99-48f3-8952-643ec2ea0f86"], "pharm_class_cs": ["Deoxyribonuclease I [CS]", "Recombinant Proteins [CS]"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]"], "pharm_class_epc": ["Recombinant Human Deoxyribonuclease 1 [EPC]"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 POUCH in 1 CARTON (50242-100-40)  / 6 AMPULE in 1 POUCH (50242-100-39)  / 2.5 mL in 1 AMPULE", "package_ndc": "50242-100-40", "marketing_start_date": "19931230"}], "brand_name": "Pulmozyme", "product_id": "50242-100_71192c41-f7be-44b0-b232-1f74369239a0", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Deoxyribonuclease I [CS]", "Recombinant Human Deoxyribonuclease 1 [EPC]", "Recombinant Proteins [CS]"], "product_ndc": "50242-100", "generic_name": "dornase alfa", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pulmozyme", "active_ingredients": [{"name": "DORNASE ALFA", "strength": "1 mg/mL"}], "application_number": "BLA103532", "marketing_category": "BLA", "marketing_start_date": "19931230", "listing_expiration_date": "20261231"}