FDA.reportPublic FDA data

LOQTORZI

Product NDC
70114-340
11-digit product format
701140340
Labeler code
70114
Product ID
70114-340_f43eeff1-8d3a-4ff5-9331-da5ab549ea25
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

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
LOQTORZITORIPALIMAB-TPZICoherus Oncology, Inc.82e7921a-1e84-4988-9799-0ad7d19b2a752026-07-23Warnings, Adverse reactionsExact identifier
application number: BLA761240
ndc (product): 70114-340

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761240Loqtorzitoripalimab-tpzi351(a)Rx2026-06-01

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