FDA.reportPublic FDA data

Tecentriq Hybreza

Product NDC
50242-933
11-digit product format
502420933
Labeler code
50242
Product ID
50242-933_87c7ca7b-0b4e-456a-8338-80c9613edb36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atezolizumab and hyaluronidase-tqjs
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Genentech, Inc.
Application
BLA761347
Marketing category
BLA
Marketing start
2024-09-12
Substance
ATEZOLIZUMAB; HYALURONIDASE (HUMAN RECOMBINANT)
Active strength
1875; 30000 mg/15mL; U/15mL
Pharmacologic classes
Antibodies [CS], Antibodies, Monoclonal [CS], Antibodies, Monoclonal, Humanized [CS], Endoglycosidase [EPC], Glycoside Hydrolases [CS], Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATEZOLIZUMAB1875 mg/15mL
HYALURONIDASE (HUMAN RECOMBINANT)30000 U/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
52CMI0WC3YInternal UNII lookup
743QUY4VD8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2693892Internal RxNorm lookup
2693899Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a617b089-ce66-464b-987b-b45d029b4d6fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fba5a780-b52d-4964-b662-1526b044aec4Product name120260127
64196b0b-840e-435b-8afa-0b0e9d9cea99Product name120251024
4b151d8d-9b47-43df-bccb-6abc1c4e7194Product name120250331
d745a796-f789-46a3-afa3-79dead22a863Product name120250331
00bb4496-246c-4f2c-910a-2b2783035958Product name120231025
bd11614e-4776-4a92-aaca-2bcbb5f710edProduct name120210115
0c6eff6a-9a1e-468b-b9ca-6bc864c2e8cbProduct name120200925
6d78c268-2e9d-bd45-9f2d-965fd0e582caProduct name220200323
b914e981-d6dc-4748-bd51-accd6b85b817Product name120190618
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
4597a7a9-59c8-4eb4-b516-4f26fa3dfe4bProduct name120170804
e9aa57cd-1aee-4951-aa77-7162f5d3e63fProduct name120160707
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-933-01Tecentriq Hybreza15 mL in 1 VIAL, SINGLE-DOSEINJECTION157
50242-933-01Tecentriq Hybreza1 in 1 BOXINJECTION17
50242-933-86Tecentriq Hybreza15 mL in 1 VIAL, SINGLE-DOSEINJECTION157
50242-933-86Tecentriq Hybreza1 in 1 BOXINJECTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-933-01ML - Milliliter50242-93368b9a7d2-2dbb-4d85-8068-bfceb6d1746012024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-933TECENTRIQ HYBREZA (ATEZOLIZUMAB AND HYALURONIDASE-TQJS) INJECTION [GENENTECH, INC.]1Current NDC, 4 package rows20240927_a617b089-ce66-464b-987b-b45d029b4d6f.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
Tecentriq HybrezaATEZOLIZUMAB AND HYALURONIDASE-TQJSGenentech, Inc.a617b089-ce66-464b-987b-b45d029b4d6f2026-05-20Warnings, Adverse reactionsExact identifier
application number: BLA761347
ndc (product): 50242-933

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761347Tecentriq Hybrezaatezolizumab and hyaluronidase-tqjs351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2693892atezolizumab-hyaluronidase-tqjs 1875 MG / 30,000 UNT in 15 ML InjectionPSNa617b089-ce66-464b-987b-b45d029b4d6f7
2693899Tecentriq Hybreza 1875 MG / 30,000 UNT in 15 ML InjectionPSNa617b089-ce66-464b-987b-b45d029b4d6f7
269389915 ML atezolizumab-tqjs 125 MG/ML / hyaluronidase-tqjs 2000 UNT/ML Injection [Tecentriq Hybreza]SBDa617b089-ce66-464b-987b-b45d029b4d6f7
269389215 ML atezolizumab-tqjs 125 MG/ML / hyaluronidase-tqjs 2000 UNT/ML InjectionSCDa617b089-ce66-464b-987b-b45d029b4d6f7
2693892atezolizumab-hyaluronidase-tqjs 1875 MG / 30,000 UNT per 15 ML InjectionSYa617b089-ce66-464b-987b-b45d029b4d6f7
2693899Tecentriq Hybreza (atezolizumab-hyaluronidase-tqjs 1875 MG / 30,000 UNT) per 15 ML InjectionSYa617b089-ce66-464b-987b-b45d029b4d6f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50242-933-01502420933011 VIAL, SINGLE-DOSE in 1 BOX (50242-933-01) / 15 mL in 1 VIAL, SINGLE-DOSE2024-09-12NoNoCurrent
50242-933-86502420933861 VIAL, SINGLE-DOSE in 1 BOX (50242-933-86) / 15 mL in 1 VIAL, SINGLE-DOSE2024-09-12YesNoCurrent