Home NDC 0069-0809 INFLECTRA
Product NDC 0069-0809
11-digit product format 000690809
Labeler code 0069
Product ID 0069-0809_421960f4-55cd-4bf8-9f00-b980b020e7a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name infliximab-dyyb
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Pfizer Laboratories Div Pfizer Inc
Application BLA125544
Marketing category BLA
Marketing start 2016-11-21
Substance INFLIXIMAB
Active strength 100 mg/10mL
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 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join INFLECTRA INFLIXIMAB-DYYB Pfizer Laboratories Div Pfizer Inc 37eaca10-d812-48bc-8b8e-b836bfa9968f 2026-07-28 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125544 ndc (product): 0069-0809
Additional Listing Data#
Finished product Yes
Brand name base INFLECTRA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INFLIXIMAB 100 mg/10mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1790541 Internal RxNorm lookup 1790546 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 0069-0809-01 2020-08-14 C162847 48780-1 ab0e2407-2f45-f274-e053-dbdaa90a6471 These highlights do not include all the information needed to use INFLECTRA safely and effectively. See full prescribing information for INFLECTRA. INFLECTRA ® (infliximab-dyyb) for injection, for intravenous use Initial U.S. Approval: 2016 INFLECTRA (infliximab-dyyb) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful diffe 0069-0809-01 2020-08-14 C162847 48780-1 ab0e2407-2f45-f274-e053-dbdaa90a6471 These highlights do not include all the information needed to use INFLECTRA safely and effectively. See full prescribing information for INFLECTRA. INFLECTRA ® (infliximab-dyyb) for injection, for intravenous use Initial U.S. Approval: 2016 INFLECTRA (infliximab-dyyb) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful diffe 0069-0809-01 2020-07-22 C162847 48780-1 ab0e2407-2f45-f274-e053-dbdaa90a6471 These highlights do not include all the information needed to use INFLECTRA safely and effectively. See full prescribing information for INFLECTRA. INFLECTRA ® (infliximab-dyyb) for injection, for intravenous use Initial U.S. Approval: 2016 INFLECTRA (infliximab-dyyb) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful diffe 0069-0809-01 2020-07-22 C162847 48780-1 ab0e2407-2f45-f274-e053-dbdaa90a6471 These highlights do not include all the information needed to use INFLECTRA safely and effectively. See full prescribing information for INFLECTRA. INFLECTRA ® (infliximab-dyyb) for injection, for intravenous use Initial U.S. Approval: 2016 INFLECTRA (infliximab-dyyb) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful diffe
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0069-0809-01 INFLECTRA 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 23 0069-0809-01 INFLECTRA 10 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 10 23
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-0809 INFLECTRA (INFLIXIMAB-DYYB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 22 Current NDC, Legacy NDC, 2 package rows 20240830_37eaca10-d812-48bc-8b8e-b836bfa9968f.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125544 Inflectra infliximab-dyyb 351(k) Biosimilar Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0069-0809-01 00069080901 1 VIAL, SINGLE-USE in 1 CARTON (0069-0809-01) / 10 mL in 1 VIAL, SINGLE-USE 2016-11-21 0000-00-00 No No Current