alteplase 50 MG Injection

RxCUI: 1804804
RxNorm name: alteplase 50 MG Injection
Display name: alteplase 50 MG Injection
Full name: alteplase 50 MG Injection
Term type: PSN
Status: DailyMed mapping
Updated: 2026-06-04 23:39:20

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103172	Activase	alteplase	351(a)	Rx	2026-07-01

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Activase	ALTEPLASE	Genentech, Inc.	c669f77c-fa48-478b-a14b-80b20a0139c2	2026-01-20	Warnings, Adverse reactions	Exact identifier rxcui: 1804804

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set ID	RxNorm mappings	Terms	SPL version	Label	Effective
c669f77c-fa48-478b-a14b-80b20a0139c2	alteplase 50 MG Injection [PSN] · alteplase 50 MG Injection [SCD]	2	15	These highlights do not include all the information needed to use ACTIVASE safely and effectively. See full prescribing information for ACTIVASE. Activase (alteplase) for injection, for intravenous use Initial U.S. Approval: 1987	20260120