FDA.reportPublic FDA data

ZYMFENTRA

Product NDC
72606-047
11-digit product format
726060047
Labeler code
72606
Product ID
72606-047_93e680bc-fd2e-4df7-9c72-70695026ad8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
infliximab-dyyb
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
CELLTRION USA Inc.
Application
BLA761358
Marketing category
BLA
Marketing start
2024-03-01
Substance
INFLIXIMAB-DYYB
Active strength
120 mg/mL
Pharmacologic classes
Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZYMFENTRA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INFLIXIMAB-DYYB120 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB72HH48FLU
Rxcui797544, 2675742, 2675749, 2675753, 2675757

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
72606-047-01ZYMFENTRA1 mL in 1 SYRINGEINJECTION19
72606-047-01ZYMFENTRA1 in 1 CARTONINJECTION19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72606-047ZYMFENTRA (INFLIXIMAB-DYYB) KIT ZYMFENTRA (INFLIXIMAB-DYYB) INJECTION [CELLTRION USA INC.]8Current NDC, 2 package rows20250519_93a193ab-9f96-4da6-aa7c-31212e81879a.zip

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
72606-047-01726060047011 SYRINGE in 1 CARTON (72606-047-01) / 1 mL in 1 SYRINGE1 syringe2024-03-01YesNoCurrent