FDA.reportPublic FDA data

ZYNYZ

Product NDC
50881-006
11-digit product format
508810006
Labeler code
50881
Product ID
50881-006_4b5a0ce6-7f12-44aa-9b45-05188a37da9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
retifanlimab-dlwr
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Incyte Corporation
Application
BLA761334
Marketing category
BLA
Marketing start
2023-03-22
Substance
RETIFANLIMAB
Active strength
25 mg/mL
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RETIFANLIMAB25 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2Y3T5IF01ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2632985Internal RxNorm lookup
2632991Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
109648d0-d30a-42fc-8273-39cb1540a751Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8b42fb54-811a-4a53-bb1e-10efdc21c87cProduct name120240419
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50881-006-03ZYNYZ1 in 1 CARTONINJECTION116
50881-006-03ZYNYZ20 mL in 1 VIAL, SINGLE-USEINJECTION2016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50881-006-03ML - Milliliter50881-0061083fdee-040e-432b-a9a6-11f456bb6ae812023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50881-006ZYNYZ (RETIFANLIMAB-DLWR) INJECTION [INCYTE CORPORATION]7Current NDC, 2 package rows20240418_109648d0-d30a-42fc-8273-39cb1540a751.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
ZYNYZRETIFANLIMAB-DLWRIncyte Corporation109648d0-d30a-42fc-8273-39cb1540a7512026-05-18Warnings, Adverse reactionsExact identifier
application number: BLA761334
ndc (product): 50881-006

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761334Zynyzretifanlimab-dlwr351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2632985retifanlimab-dlw 500 MG in 20 ML InjectionPSN109648d0-d30a-42fc-8273-39cb1540a75116
2632991ZYNYZ 500 MG in 20 ML InjectionPSN109648d0-d30a-42fc-8273-39cb1540a75116
263299120 ML retifanlimab-dlwr 25 MG/ML Injection [Zynyz]SBD109648d0-d30a-42fc-8273-39cb1540a75116
263298520 ML retifanlimab-dlwr 25 MG/ML InjectionSCD109648d0-d30a-42fc-8273-39cb1540a75116
263299120 ML Zynyz 25 MG/ML InjectionSY109648d0-d30a-42fc-8273-39cb1540a75116
2632985retifanlimab-dlw 500 MG per 20 ML InjectionSY109648d0-d30a-42fc-8273-39cb1540a75116
2632991Zynyz 500 MG per 20 ML InjectionSY109648d0-d30a-42fc-8273-39cb1540a75116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50881-006-03508810006031 VIAL, SINGLE-USE in 1 CARTON (50881-006-03) / 20 mL in 1 VIAL, SINGLE-USE2023-03-22NoNoCurrent