FDA.reportPublic FDA data

Pulmozyme

Product NDC
50242-100
11-digit product format
502420100
Labeler code
50242
Product ID
50242-100_71192c41-f7be-44b0-b232-1f74369239a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dornase alfa
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Genentech, Inc.
Application
BLA103532
Marketing category
BLA
Marketing start
1993-12-30
Substance
DORNASE ALFA
Active strength
1 mg/mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Deoxyribonuclease I [CS], Recombinant Human Deoxyribonuclease 1 [EPC], Recombinant Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pulmozyme
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DORNASE ALFA1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
953A26OA1YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
205532Internal RxNorm lookup
310014Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d8c78a7e-ff99-48f3-8952-643ec2ea0f86Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-100-39Pulmozyme2.5 mL in 1 AMPULESOLUTION2.524
50242-100-39Pulmozyme6 in 1 POUCHSOLUTION624
50242-100-40Pulmozyme5 in 1 CARTONSOLUTION524

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-100-39ML - Milliliter50242-1003d1ce8c3-846d-4f9c-a9b5-2eb592aee2a312022-06-06
50242-100-40ML - Milliliter50242-10092251138-bb3f-4b4b-abfe-cba4a18e878712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DORNASE ALFAACTIVE INGREDIENT953A26OA1YPULMOZYME (DORNASE ALFA) SOLUTION [GENENTECH, INC.]8
DORNASE ALFAACTIVE MOIETY953A26OA1YPULMOZYME (DORNASE ALFA) SOLUTION [GENENTECH, INC.]8
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MPULMOZYME (DORNASE ALFA) SOLUTION [GENENTECH, INC.]8
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPULMOZYME (DORNASE ALFA) SOLUTION [GENENTECH, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-100PULMOZYME (DORNASE ALFA) SOLUTION [GENENTECH, INC.]23Current NDC, Legacy NDC, 3 package rows20241206_d8c78a7e-ff99-48f3-8952-643ec2ea0f86.zip

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
application number: BLA103532
ndc (product): 50242-100

Purple Book Biologic Products#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310014dornase alfa 1 MG/ML Inhalation SolutionPSNd8c78a7e-ff99-48f3-8952-643ec2ea0f8624
205532PULMOZYME 1 MG/ML Inhalation SolutionPSNd8c78a7e-ff99-48f3-8952-643ec2ea0f8624
205532dornase alfa 1 MG/ML Inhalation Solution [Pulmozyme]SBDd8c78a7e-ff99-48f3-8952-643ec2ea0f8624
310014dornase alfa 1 MG/ML Inhalation SolutionSCDd8c78a7e-ff99-48f3-8952-643ec2ea0f8624
205532Pulmozyme 1 MG/ML Inhalation SolutionSYd8c78a7e-ff99-48f3-8952-643ec2ea0f8624

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50242-100-39502420100392.5 mL in 1 AMPULE2.5 mlHistorical
50242-100-40502420100405 POUCH in 1 CARTON (50242-100-40) / 6 AMPULE in 1 POUCH (50242-100-39) / 2.5 mL in 1 AMPULE5 pouch1993-12-300000-00-00NoNoCurrent