FDA.reportPublic FDA data

tesamorelin 11.6 MG Injection

RxCUI
2719314
RxNorm name
tesamorelin 11.6 MG Injection
Display name
tesamorelin 11.6 MG Injection
Full name
tesamorelin 11.6 MG Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:06

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 WRTESAMORELINTheratechnologies Inc.839334d3-8c1d-4c26-9036-2ab524a6ea752026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 2719314

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
839334d3-8c1d-4c26-9036-2ab524a6ea75tesamorelin 11.6 MG InjectionPSN1These highlights do not include all the information needed to use EGRIFTA WR safely and effectively. See full prescribing information for EGRIFTA WR. EGRIFTA WR™ (tesamorelin) for injection, for subcutaneous use Initial U.S. Approval: 201020250331
839334d3-8c1d-4c26-9036-2ab524a6ea75tesamorelin 11.6 MG (as tesamorelin acetate 11.9 MG) InjectionSY1These highlights do not include all the information needed to use EGRIFTA WR safely and effectively. See full prescribing information for EGRIFTA WR. EGRIFTA WR™ (tesamorelin) for injection, for subcutaneous use Initial U.S. Approval: 201020250331
839334d3-8c1d-4c26-9036-2ab524a6ea75tesamorelin 11.6 MG InjectionSCD1These highlights do not include all the information needed to use EGRIFTA WR safely and effectively. See full prescribing information for EGRIFTA WR. EGRIFTA WR™ (tesamorelin) for injection, for subcutaneous use Initial U.S. Approval: 201020250331