FDA.reportPublic FDA data

TROGARZO

Product NDC
62064-122
11-digit product format
620640122
Labeler code
62064
Product ID
62064-122_c04624be-0e28-4902-954c-730ccdbfd162
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibalizumab
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Theratechnologies Inc.
Application
BLA761065
Marketing category
BLA
Marketing start
2018-04-20
Substance
IBALIZUMAB
Active strength
150 mg/mL
Pharmacologic classes
Antibodies, Monoclonal, Humanized [CS], CD4-directed Antibody Interactions [MoA], CD4-directed Blocking Antibody [EPC], HIV 1 Post-attachment Fusion Inhibitors [MoA], Human Immunodeficiency Virus 1 Post-attachment Fusion Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBALIZUMAB150 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLT369U66CE
Rxcui2043317, 2043322

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be97f4e8-6739-4197-a91d-3c7e97bf7262Product name120180529
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62064-122-022024-02-01C16284748780-11030e365-674d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TROGARZO safely and effectively. See full prescribing information for TROGARZO. TROGARZO ® (ibalizumab-uiyk) injection, for intravenous use Initial U.S. Approval: 2018
62064-122-022024-02-01C16284748780-11030e365-674d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TROGARZO safely and effectively. See full prescribing information for TROGARZO. TROGARZO ® (ibalizumab-uiyk) injection, for intravenous use Initial U.S. Approval: 2018
62064-122-022024-01-30C16284748780-11030e365-674d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TROGARZO safely and effectively. See full prescribing information for TROGARZO. TROGARZO ® (ibalizumab-uiyk) injection, for intravenous use Initial U.S. Approval: 2018
62064-122-022024-01-30C16284748780-11030e365-674d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use TROGARZO safely and effectively. See full prescribing information for TROGARZO. TROGARZO ® (ibalizumab-uiyk) injection, for intravenous use Initial U.S. Approval: 2018

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62064-122-01TROGARZO1.33 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION1.3313
62064-122-02TROGARZO2 in 1 CARTONINJECTION, SOLUTION213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62064-122-01ML - Milliliter62064-12287e5a419-3302-48f8-828a-2def17de2cff12018-04-19
62064-122-02ML - Milliliter62064-1225714f190-d8fe-4066-abe2-f1def20be70312018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62064-122TROGARZO (IBALIZUMAB) INJECTION, SOLUTION [THERATECHNOLOGIES INC.]12Current NDC, Legacy NDC, 2 package rows20250101_c548ad82-9d1f-4d16-95b6-4e6106badf43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2043317ibalizumab-uiyk 200 MG in 1.33 mL InjectionPSNc548ad82-9d1f-4d16-95b6-4e6106badf4313
2043322TROGARZO 200 MG in 1.33 mL InjectionPSNc548ad82-9d1f-4d16-95b6-4e6106badf4313
20433221.33 ML ibalizumab-uiyk 150 MG/ML Injection [Trogarzo]SBDc548ad82-9d1f-4d16-95b6-4e6106badf4313
20433171.33 ML ibalizumab-uiyk 150 MG/ML InjectionSCDc548ad82-9d1f-4d16-95b6-4e6106badf4313
20433221.33 ML Trogarzo 150 MG/ML InjectionSYc548ad82-9d1f-4d16-95b6-4e6106badf4313
2043317ibalizumab-uiyk 200 MG per 1.33 ML InjectionSYc548ad82-9d1f-4d16-95b6-4e6106badf4313
2043322TROGARZO 200 MG per 1.33 ML InjectionSYc548ad82-9d1f-4d16-95b6-4e6106badf4313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62064-122-01620640122011.33 mL in 1 VIAL, SINGLE-USE1.33 mlHistorical
62064-122-02620640122022 VIAL, SINGLE-USE in 1 CARTON (62064-122-02) / 1.33 mL in 1 VIAL, SINGLE-USE (62064-122-01) 2018-04-200000-00-00NoNoCurrent