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 Identifiers#

Field, Values table
FieldValues
Rxcui1804799, 1804802, 1804804, 1804806

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

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