FDA.reportPublic FDA data

EGRIFTA SV

Product NDC
62064-241
11-digit product format
620640241
Labeler code
62064
Product ID
62064-241_5ab4cb50-9122-4d50-b33a-f70f6638218b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tesamorelin
Dosage form
KIT
Route
SUBCUTANEOUS
Labeler
Theratechnologies Inc.
Application
BLA022505
Marketing category
BLA
Marketing start
2019-11-04
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EGRIFTA SV
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
1044587Internal RxNorm lookup
1044591Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3d783378-b02d-4f19-99dd-0fc91a042224Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd59cd9-c847-4812-bf4a-c404905392f8Product name120260108
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-02-01These 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: 2010
2024-02-01These 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: 2010
2024-01-30These 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: 2010
2024-01-30These 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: 2010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62064-241-30EGRIFTA SV1 in 1 BOXKIT18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62064-241-30EA - Each62064-241ebe5a18b-7beb-4ece-b2f0-93d432430b9a12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62064-241EGRIFTA SV (TESAMORELIN) KIT [THERATECHNOLOGIES INC.]7Current NDC, Legacy NDC, 1 package rows20241222_3d783378-b02d-4f19-99dd-0fc91a042224.zip

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
EGRIFTA SVTESAMORELINTheratechnologies Inc.3d783378-b02d-4f19-99dd-0fc91a0422242026-07-29Warnings, Adverse reactionsExact identifier
application number: BLA022505
ndc (product): 62064-241

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
1044591Egrifta 2 MG InjectionPSN3d783378-b02d-4f19-99dd-0fc91a0422248
1044587tesamorelin 2 MG InjectionPSN3d783378-b02d-4f19-99dd-0fc91a0422248
1044591tesamorelin 2 MG Injection [Egrifta]SBD3d783378-b02d-4f19-99dd-0fc91a0422248
1044587tesamorelin 2 MG InjectionSCD3d783378-b02d-4f19-99dd-0fc91a0422248
1044591Egrifta 2 MG InjectionSY3d783378-b02d-4f19-99dd-0fc91a0422248

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62064-241-30620640241301 KIT in 1 BOX (62064-241-30) * 30 BOTTLE in 1 TRAY / 10 mL in 1 BOTTLE * .5 mL in 1 VIAL1 kit2019-11-040000-00-00NoNoCurrent