FDA.reportPublic FDA data

ZYMFENTRA

Product NDC
72606-025
Requested package NDC
72606-025-12
11-digit product format
726060025
Labeler code
72606
Product ID
72606-025_93e680bc-fd2e-4df7-9c72-70695026ad8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
infliximab-dyyb
Dosage form
KIT
Labeler
CELLTRION USA Inc.
Application
BLA761358
Marketing category
BLA
Marketing start
2024-03-01
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72606-02572606-025-12IInactivated by FDA2026-08-17

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd7a994a-5706-4fb6-ad0f-bf950de5c161Product name120250721
6e0fa83e-7840-4808-ae8f-3478d418847bProduct name120230703
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
72606-025-01ZYMFENTRA1 in 1 CARTONKIT19
72606-025-01ZYMFENTRA1 in 1 KITKIT19
72606-025-02ZYMFENTRA1 in 1 KITKIT19
72606-025-02ZYMFENTRA2 in 1 CARTONKIT29
72606-025-03ZYMFENTRA1 in 1 KITKIT19
72606-025-03ZYMFENTRA4 in 1 CARTONKIT49
72606-025-04ZYMFENTRA6 in 1 CARTONKIT69
72606-025-04ZYMFENTRA1 in 1 KITKIT19
72606-025-05ZYMFENTRA1 in 1 KITKIT19
72606-025-05ZYMFENTRA1 in 1 CARTONKIT19
72606-025-06ZYMFENTRA1 in 1 KITKIT19
72606-025-06ZYMFENTRA2 in 1 CARTONKIT29
72606-025-07ZYMFENTRA4 in 1 CARTONKIT49
72606-025-07ZYMFENTRA1 in 1 KITKIT19
72606-025-08ZYMFENTRA1 in 1 KITKIT19
72606-025-08ZYMFENTRA6 in 1 CARTONKIT69
72606-025-09ZYMFENTRA1 in 1 CARTONKIT19
72606-025-09ZYMFENTRA1 in 1 KITKIT19
72606-025-10ZYMFENTRA1 in 1 KITKIT19
72606-025-10ZYMFENTRA2 in 1 CARTONKIT29
72606-025-11ZYMFENTRA1 in 1 KITKIT19
72606-025-11ZYMFENTRA4 in 1 CARTONKIT49
72606-025-12ZYMFENTRA6 in 1 CARTONKIT69
72606-025-12ZYMFENTRA1 in 1 KITKIT19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72606-025-01EA - Each72606-025695e17b4-0131-42f4-901e-393f66c437f112024-03-12
72606-025-02EA - Each72606-025e2555fec-6a42-4319-b660-57e11f1bd92c12024-03-12
72606-025-10EA - Each72606-0259c7d4df6-cfb2-42fc-8096-cd8c397281f412024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72606-025ZYMFENTRA (INFLIXIMAB-DYYB) KIT ZYMFENTRA (INFLIXIMAB-DYYB) INJECTION [CELLTRION USA INC.]8Current NDC, 24 package rows20250519_93a193ab-9f96-4da6-aa7c-31212e81879a.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
ZYMFENTRAINFLIXIMAB-DYYBCELLTRION USA Inc.93a193ab-9f96-4da6-aa7c-31212e81879a2025-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761358
ndc (package): 72606-025-12
ndc (product): 72606-025
ndc11 (package): 72606002512

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761358Zymfentrainfliximab-dyyb351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2675742inFLIXimab-dyyb 120 MG in 1 ML Pen InjectorPSN93a193ab-9f96-4da6-aa7c-31212e81879a9
2675753inFLIXimab-dyyb 120 MG in 1 ML Prefilled SyringePSN93a193ab-9f96-4da6-aa7c-31212e81879a9
797544isopropyl alcohol 70 % Medicated PadPSN93a193ab-9f96-4da6-aa7c-31212e81879a9
2675749Zymfentra 120 MG in 1 ML Pen InjectorPSN93a193ab-9f96-4da6-aa7c-31212e81879a9
2675757Zymfentra 120 MG in 1 ML Prefilled SyringePSN93a193ab-9f96-4da6-aa7c-31212e81879a9
26757491 ML infliximab-dyyb 120 MG/ML Pen Injector [Zymfentra]SBD93a193ab-9f96-4da6-aa7c-31212e81879a9
26757571 ML infliximab-dyyb 120 MG/ML Prefilled Syringe [Zymfentra]SBD93a193ab-9f96-4da6-aa7c-31212e81879a9
26757421 ML infliximab-dyyb 120 MG/ML Pen InjectorSCD93a193ab-9f96-4da6-aa7c-31212e81879a9
26757531 ML infliximab-dyyb 120 MG/ML Prefilled SyringeSCD93a193ab-9f96-4da6-aa7c-31212e81879a9
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD93a193ab-9f96-4da6-aa7c-31212e81879a9
26757491 ML Zymfentra 120 MG/ML Pen InjectorSY93a193ab-9f96-4da6-aa7c-31212e81879a9
26757571 ML Zymfentra 120 MG/ML Prefilled SyringeSY93a193ab-9f96-4da6-aa7c-31212e81879a9
2675742infliximab-dyyb 120 MG per 1 ML Pen InjectorSY93a193ab-9f96-4da6-aa7c-31212e81879a9
2675753infliximab-dyyb 120 MG per 1 ML Prefilled SyringeSY93a193ab-9f96-4da6-aa7c-31212e81879a9
797544isopropyl alcohol 70 % Medicated PadSY93a193ab-9f96-4da6-aa7c-31212e81879a9
797544isopropyl alcohol 70 % Topical ClothSY93a193ab-9f96-4da6-aa7c-31212e81879a9
797544isopropyl alcohol 70 % Topical SwabSY93a193ab-9f96-4da6-aa7c-31212e81879a9
2675749Zymfentra 120 MG per 1 ML Pen InjectorSY93a193ab-9f96-4da6-aa7c-31212e81879a9
2675757Zymfentra 120 MG per 1 ML Prefilled SyringeSY93a193ab-9f96-4da6-aa7c-31212e81879a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72606-025-12726060025126 KIT in 1 CARTON (72606-025-12) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKET6 kit2024-03-01NoNoHistorical