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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761347Tecentriq Hybrezaatezolizumab and hyaluronidase-tqjs351(a)Rx2026-06-01

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