Home NDC 72606-047 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 Ingredient Strength INFLIXIMAB-DYYB 120 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination B72HH48FLU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 797544 Internal RxNorm lookup 2675742 Internal RxNorm lookup 2675749 Internal RxNorm lookup 2675753 Internal RxNorm lookup 2675757 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72606-047-01 ZYMFENTRA 1 mL in 1 SYRINGE INJECTION 1 9 72606-047-01 ZYMFENTRA 1 in 1 CARTON INJECTION 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72606-047 ZYMFENTRA (INFLIXIMAB-DYYB) KIT ZYMFENTRA (INFLIXIMAB-DYYB) INJECTION [CELLTRION USA INC.] 8 Current NDC, 2 package rows 20250519_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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761358 Zymfentra infliximab-dyyb 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72606-047-01 72606004701 1 SYRINGE in 1 CARTON (72606-047-01) / 1 mL in 1 SYRINGE 1 syringe 2024-03-01 Yes No Current