FDA.reportPublic FDA data

TECENTRIQ

Product NDC
50242-918
11-digit product format
502420918
Labeler code
50242
Product ID
50242-918_4b922b35-c401-4189-a8b2-9f9a820878db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atezolizumab
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Genentech, Inc.
Application
BLA761034
Marketing category
BLA
Marketing start
2019-03-08
Substance
ATEZOLIZUMAB
Active strength
840 mg/14mL
Pharmacologic classes
Antibodies [CS], Antibodies, Monoclonal [CS], Antibodies, Monoclonal, Humanized [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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATEZOLIZUMAB840 mg/14mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1792780Internal RxNorm lookup
1792785Internal RxNorm lookup
2119695Internal RxNorm lookup
2119696Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6fa682c9-a312-4932-9831-f286908660eeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4b151d8d-9b47-43df-bccb-6abc1c4e7194Product name120250331
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
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
50242-918-01TECENTRIQ1 in 1 CARTONINJECTION, SOLUTION145
50242-918-01TECENTRIQ14 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION1445

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-918-01ML - Milliliter50242-918f82e2f73-3292-45df-a075-b10cf9d211e112019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-918TECENTRIQ (ATEZOLIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]37Current NDC, Legacy NDC, 2 package rows20241122_6fa682c9-a312-4932-9831-f286908660ee.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
TECENTRIQATEZOLIZUMABGenentech, Inc.6fa682c9-a312-4932-9831-f286908660ee2026-05-20Warnings, Adverse reactionsExact identifier
application number: BLA761034
ndc (product): 50242-918

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761034Tecentriqatezolizumab351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1792780atezolizumab 1200 MG in 20 ML InjectionPSN6fa682c9-a312-4932-9831-f286908660ee45
2119695atezolizumab 840 MG in 14 ML InjectionPSN6fa682c9-a312-4932-9831-f286908660ee45
1792785Tecentriq 1200 MG in 20 ML InjectionPSN6fa682c9-a312-4932-9831-f286908660ee45
2119696Tecentriq 840 MG in 14 ML InjectionPSN6fa682c9-a312-4932-9831-f286908660ee45
211969614 ML atezolizumab 60 MG/ML Injection [Tecentriq]SBD6fa682c9-a312-4932-9831-f286908660ee45
179278520 ML atezolizumab 60 MG/ML Injection [Tecentriq]SBD6fa682c9-a312-4932-9831-f286908660ee45
211969514 ML atezolizumab 60 MG/ML InjectionSCD6fa682c9-a312-4932-9831-f286908660ee45
179278020 ML atezolizumab 60 MG/ML InjectionSCD6fa682c9-a312-4932-9831-f286908660ee45
211969614 ML Tecentriq 60 MG/ML InjectionSY6fa682c9-a312-4932-9831-f286908660ee45
179278520 ML Tecentriq 60 MG/ML InjectionSY6fa682c9-a312-4932-9831-f286908660ee45
1792780atezolizumab 1200 MG per 20 ML InjectionSY6fa682c9-a312-4932-9831-f286908660ee45
2119695atezolizumab 840 MG per 14 ML InjectionSY6fa682c9-a312-4932-9831-f286908660ee45
1792785Tecentriq 1200 MG per 20 ML InjectionSY6fa682c9-a312-4932-9831-f286908660ee45
2119696Tecentriq 840 MG per 14 ML InjectionSY6fa682c9-a312-4932-9831-f286908660ee45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50242-918-01502420918011 VIAL, SINGLE-USE in 1 CARTON (50242-918-01) / 14 mL in 1 VIAL, SINGLE-USE2019-03-080000-00-00NoNoCurrent
50242-918-86502420918861 VIAL, SINGLE-USE in 1 CARTON (50242-918-86) > 14 mL in 1 VIAL, SINGLE-USE2019-03-080000-00-00YesNoCurrent