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
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1044587, 1044591

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62064-241-302024-02-01C16284748780-11030e365-0e8a-111a-e063-dadaa90a10e2These 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
62064-241-302024-01-30C16284748780-11030e365-0e8a-111a-e063-dadaa90a10e2These 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

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