FDA.reportPublic FDA data

Activase

Product NDC
50242-044
11-digit product format
502420044
Labeler code
50242
Product ID
50242-044_48ed2eb6-728a-41d8-b024-6b34e75dc4dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alteplase
Dosage form
KIT
Labeler
Genentech, Inc.
Application
BLA103172
Marketing category
BLA
Marketing start
1987-11-13
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Activase
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1804799Internal RxNorm lookup
1804802Internal RxNorm lookup
1804804Internal RxNorm lookup
1804806Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c669f77c-fa48-478b-a14b-80b20a0139c2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-044-13Activase1 in 1 CARTONKIT115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-044-13EA - Each50242-044d3ec233c-2836-4747-ba1d-382dfe16a76912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALTEPLASEACTIVE INGREDIENT1RXS4UE564ACTIVASE (ALTEPLASE) KIT [GENENTECH, INC.]3
ALTEPLASEACTIVE MOIETY1RXS4UE564ACTIVASE (ALTEPLASE) KIT [GENENTECH, INC.]3
ARGININEINACTIVE INGREDIENT94ZLA3W45FACTIVASE (ALTEPLASE) KIT [GENENTECH, INC.]3
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNACTIVASE (ALTEPLASE) KIT [GENENTECH, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HACTIVASE (ALTEPLASE) KIT [GENENTECH, INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RACTIVASE (ALTEPLASE) KIT [GENENTECH, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-044ACTIVASE (ALTEPLASE) KIT [GENENTECH, INC.]14Current NDC, Legacy NDC, 1 package rows20250510_c669f77c-fa48-478b-a14b-80b20a0139c2.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cathflo ActivaseALTEPLASEGenentech, Inc.91ecdef2-95ff-42dd-a31c-c8a09cab3ad92026-01-20Warnings, Adverse reactionsExact identifier
application number: BLA103172
ActivaseALTEPLASEGenentech, Inc.c669f77c-fa48-478b-a14b-80b20a0139c22026-01-20Warnings, Adverse reactionsExact identifier
application number: BLA103172
ndc (product): 50242-044

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103172Activasealteplase351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1804802ACTIVASE 100 MG InjectionPSNc669f77c-fa48-478b-a14b-80b20a0139c215
1804806ACTIVASE 50 MG InjectionPSNc669f77c-fa48-478b-a14b-80b20a0139c215
1804799alteplase 100 MG InjectionPSNc669f77c-fa48-478b-a14b-80b20a0139c215
1804804alteplase 50 MG InjectionPSNc669f77c-fa48-478b-a14b-80b20a0139c215
1804802alteplase 100 MG Injection [Activase]SBDc669f77c-fa48-478b-a14b-80b20a0139c215
1804806alteplase 50 MG Injection [Activase]SBDc669f77c-fa48-478b-a14b-80b20a0139c215
1804799alteplase 100 MG InjectionSCDc669f77c-fa48-478b-a14b-80b20a0139c215
1804804alteplase 50 MG InjectionSCDc669f77c-fa48-478b-a14b-80b20a0139c215
1804802Activase 100 MG InjectionSYc669f77c-fa48-478b-a14b-80b20a0139c215
1804806Activase 50 MG InjectionSYc669f77c-fa48-478b-a14b-80b20a0139c215

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50242-044-13502420044131 KIT in 1 CARTON (50242-044-13) * 50 mL in 1 VIAL, SINGLE-USE * 50 mL in 1 VIAL, SINGLE-USE1 kit1987-11-130000-00-00NoNoCurrent