FDA.reportPublic FDA data

tesamorelin 2 MG Injection [Egrifta]

RxCUI
1044591
RxNorm name
tesamorelin 2 MG Injection [Egrifta]
Display name
tesamorelin 2 MG Injection [Egrifta]
Full name
tesamorelin 2 MG Injection [Egrifta]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:54

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
022505Egriftatesamorelin351(a)Disc2026-06-01

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EGRIFTA SVTESAMORELINTheratechnologies Inc.3d783378-b02d-4f19-99dd-0fc91a0422242026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 1044591

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
3d783378-b02d-4f19-99dd-0fc91a042224tesamorelin 2 MG Injection [Egrifta]SBD8These highlights do not include all the information needed to use EGRIFTA SV safely and effectively. See full prescribing information for EGRIFTA SV. EGRIFTA SV ® (tesamorelin) for injection, for subcutaneous use Initial U.S. Approval: 201020251223
3d783378-b02d-4f19-99dd-0fc91a042224Egrifta 2 MG InjectionPSN8These highlights do not include all the information needed to use EGRIFTA SV safely and effectively. See full prescribing information for EGRIFTA SV. EGRIFTA SV ® (tesamorelin) for injection, for subcutaneous use Initial U.S. Approval: 201020251223
3d783378-b02d-4f19-99dd-0fc91a042224Egrifta 2 MG InjectionSY8These highlights do not include all the information needed to use EGRIFTA SV safely and effectively. See full prescribing information for EGRIFTA SV. EGRIFTA SV ® (tesamorelin) for injection, for subcutaneous use Initial U.S. Approval: 201020251223