FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INFLIXIMAB100 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB72HH48FLU
Rxcui1790541, 1790546

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd7a994a-5706-4fb6-ad0f-bf950de5c161Product name120250721
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
6e0fa83e-7840-4808-ae8f-3478d418847bProduct name120230703
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0069-0809-012020-08-14C16284748780-1ab0e2407-2f45-f274-e053-dbdaa90a6471These 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
0069-0809-012020-07-22C16284748780-1ab0e2407-2f45-f274-e053-dbdaa90a6471These 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 NDCProductDescriptionFormQuantityStrengthSPL version
0069-0809-01INFLECTRA1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,123
0069-0809-01INFLECTRA10 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,1023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0809-01EA - Each0069-08092451daa7-b705-40f9-b2cf-c3a25d16f93e12016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0809INFLECTRA (INFLIXIMAB-DYYB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]22Current NDC, Legacy NDC, 2 package rows20240830_37eaca10-d812-48bc-8b8e-b836bfa9968f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790546INFLECTRA 100 MG InjectionPSN37eaca10-d812-48bc-8b8e-b836bfa9968f23
1790541inFLIXimab-dyyb 100 MG InjectionPSN37eaca10-d812-48bc-8b8e-b836bfa9968f23
1790546infliximab-dyyb 100 MG Injection [Inflectra]SBD37eaca10-d812-48bc-8b8e-b836bfa9968f23
1790541infliximab-dyyb 100 MG InjectionSCD37eaca10-d812-48bc-8b8e-b836bfa9968f23
1790546Inflectra 100 MG InjectionSY37eaca10-d812-48bc-8b8e-b836bfa9968f23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0069-0809-01000690809011 VIAL, SINGLE-USE in 1 CARTON (0069-0809-01) / 10 mL in 1 VIAL, SINGLE-USE2016-11-210000-00-00NoNoCurrent