FDA.reportPublic FDA data

LOQTORZI

Product NDC
70114-340
11-digit product format
701140340
Labeler code
70114
Product ID
70114-340_8a0ceb7f-ea10-4b90-97fb-530d5f2a0bd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
toripalimab-tpzi
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Coherus Oncology, Inc.
Application
BLA761240
Marketing category
BLA
Marketing start
2023-10-27
Substance
TORIPALIMAB
Active strength
240 mg/6mL
Pharmacologic classes
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TORIPALIMAB240 mg/6mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8JXN261VVAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2669413Internal RxNorm lookup
2669420Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
82e7921a-1e84-4988-9799-0ad7d19b2a75Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
de255451-cc3c-48c7-8617-613b8856b3fcProduct name120250722

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70114-340-01LOQTORZI1 in 1 CARTONINJECTION18
70114-340-01LOQTORZI6 mL in 1 VIAL, GLASSINJECTION68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70114-340-01ML - Milliliter70114-3408c9cfc66-a57e-4c49-8b1f-cc13f9c2dfa912023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70114-340LOQTORZI (TORIPALIMAB-TPZI) INJECTION [COHERUS BIOSCIENCES, INC.]6Current NDC, 2 package rows20241114_82e7921a-1e84-4988-9799-0ad7d19b2a75.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
LOQTORZITORIPALIMAB-TPZICoherus Oncology, Inc.82e7921a-1e84-4988-9799-0ad7d19b2a752026-07-23Warnings, Adverse reactionsExact identifier
application number: BLA761240
ndc (product): 70114-340

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761240Loqtorzitoripalimab-tpzi351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2669420LOQTORZI 240 MG in 6 ML InjectionPSN82e7921a-1e84-4988-9799-0ad7d19b2a758
2669413toripalimab-tpzi 240 MG in 6 ML InjectionPSN82e7921a-1e84-4988-9799-0ad7d19b2a758
26694206 ML toripalimab-tpzi 40 MG/ML Injection [Loqtorzi]SBD82e7921a-1e84-4988-9799-0ad7d19b2a758
26694136 ML toripalimab-tpzi 40 MG/ML InjectionSCD82e7921a-1e84-4988-9799-0ad7d19b2a758
26694206 ML Loqtorzi 40 MG/ML InjectionSY82e7921a-1e84-4988-9799-0ad7d19b2a758
2669420Loqtorzi 240 MG per 6 ML InjectionSY82e7921a-1e84-4988-9799-0ad7d19b2a758
2669413toripalimab-tpzi 240 MG per 6 ML InjectionSY82e7921a-1e84-4988-9799-0ad7d19b2a758

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70114-340-01701140340011 VIAL, GLASS in 1 CARTON (70114-340-01) / 6 mL in 1 VIAL, GLASS2023-10-27NoNoCurrent