FDA.reportPublic FDA data

dornase alfa 1 MG/ML Inhalation Solution

RxCUI
310014
RxNorm name
dornase alfa 1 MG/ML Inhalation Solution
Display name
dornase alfa 1 MG/ML Inhalation Solution
Full name
dornase alfa 1 MG/ML Inhalation Solution
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:23

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103532Pulmozymedornase alfa351(a)Rx2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PulmozymeDORNASE ALFAGenentech, Inc.d8c78a7e-ff99-48f3-8952-643ec2ea0f862025-12-17Warnings, Adverse reactionsExact identifier
rxcui: 310014

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
d8c78a7e-ff99-48f3-8952-643ec2ea0f86dornase alfa 1 MG/ML Inhalation SolutionPSN24These highlights do not include all the information needed to use PULMOZYME safely and effectively. See full prescribing information for PULMOZYME. PULMOZYME ® (dornase alfa) inhalation solution, for inhalation use Initial U.S. Approval: 199320251217
d8c78a7e-ff99-48f3-8952-643ec2ea0f86dornase alfa 1 MG/ML Inhalation SolutionSCD24These highlights do not include all the information needed to use PULMOZYME safely and effectively. See full prescribing information for PULMOZYME. PULMOZYME ® (dornase alfa) inhalation solution, for inhalation use Initial U.S. Approval: 199320251217