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 Identifiers#

Field, Values table
FieldValues
Unii953A26OA1Y
Rxcui205532, 310014

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

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