FDA.reportPublic FDA data

EGRIFTA WR

Product NDC
62064-381
11-digit product format
620640381
Labeler code
62064
Product ID
62064-381_deec4b7a-7e9a-4a13-bb05-8a392c4b3937
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tesamorelin
Dosage form
KIT
Route
SUBCUTANEOUS
Labeler
Theratechnologies Inc.
Application
BLA022505
Marketing category
BLA
Marketing start
2025-07-15
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2719314Internal RxNorm lookup
2719316Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
839334d3-8c1d-4c26-9036-2ab524a6ea75Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd59cd9-c847-4812-bf4a-c404905392f8Product name120260108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62064-381-04EGRIFTA WR1 in 1 BOXKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62064-381-04EA - Each62064-381b31d25a4-cec1-49cf-9bc7-f160025c538812025-08-11

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
EGRIFTA WRTESAMORELINTheratechnologies Inc.839334d3-8c1d-4c26-9036-2ab524a6ea752026-07-29Warnings, Adverse reactionsExact identifier
application number: BLA022505
ndc (product): 62064-381
EGRIFTA SVTESAMORELINTheratechnologies Inc.3d783378-b02d-4f19-99dd-0fc91a0422242026-07-29Warnings, Adverse reactionsExact identifier
application number: BLA022505

Purple Book Biologic Products#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2719316EGRIFTA WR 11.6 MG InjectionPSN839334d3-8c1d-4c26-9036-2ab524a6ea751
2719314tesamorelin 11.6 MG InjectionPSN839334d3-8c1d-4c26-9036-2ab524a6ea751
2719316tesamorelin 11.6 MG Injection [Egrifta]SBD839334d3-8c1d-4c26-9036-2ab524a6ea751
2719314tesamorelin 11.6 MG InjectionSCD839334d3-8c1d-4c26-9036-2ab524a6ea751
2719316Egrifta 11.6 MG InjectionSY839334d3-8c1d-4c26-9036-2ab524a6ea751
2719314tesamorelin 11.6 MG (as tesamorelin acetate 11.9 MG) InjectionSY839334d3-8c1d-4c26-9036-2ab524a6ea751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62064-381-04620640381041 KIT in 1 BOX (62064-381-04) * 1.3 mL in 1 VIAL (62064-371-01) * 30 mL in 1 BOTTLE1 kit2025-07-15NoNoCurrent