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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LT369U66CEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2043317Internal RxNorm lookup
2043322Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c548ad82-9d1f-4d16-95b6-4e6106badf43Available on FDA.report

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#

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

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
TROGARZOIBALIZUMABTheratechnologies Inc.c548ad82-9d1f-4d16-95b6-4e6106badf432026-01-07Warnings, Adverse reactionsExact identifier
application number: BLA761065
ndc (product): 62064-122

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761065Trogarzoibalizumab-uiyk351(a)Rx2026-06-01

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