FDA.reportPublic FDA data

Renflexis

Product NDC
78206-162
11-digit product format
782060162
Labeler code
78206
Product ID
78206-162_ae5aa866-45c5-4dd8-ace4-cabe72994604
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
infliximab
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Organon LLC
Application
BLA761054
Marketing category
BLA
Marketing start
2017-04-21
Substance
INFLIXIMAB
Active strength
100 mg/1
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
Renflexis
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INFLIXIMAB100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B72HH48FLUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1927285Internal RxNorm lookup
1927290Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dbf738c4-3fac-4422-a9d8-51d9c83a8789Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78206-162-01Renflexis1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16
78206-162-99Renflexis1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-162-01EA - Each78206-162fb7866b4-f67e-49d1-8341-cba0bf1d1dfd12021-10-08
78206-162-99EA - Each78206-162f9747780-44d4-48f9-9153-774589e1889c12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-162RENFLEXIS (INFLIXIMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ORGANON LLC]3Current NDC, Legacy NDC, 2 package rows20240110_dbf738c4-3fac-4422-a9d8-51d9c83a8789.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
RenflexisINFLIXIMABOrganon LLCdbf738c4-3fac-4422-a9d8-51d9c83a87892026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761054
ndc (product): 78206-162

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761054Renflexisinfliximab-abda351(k) BiosimilarRx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1927285inFLIXimab-abda 100 MG InjectionPSNdbf738c4-3fac-4422-a9d8-51d9c83a87896
1927290RENFLEXIS 100 MG InjectionPSNdbf738c4-3fac-4422-a9d8-51d9c83a87896
1927290infliximab-abda 100 MG Injection [Renflexis]SBDdbf738c4-3fac-4422-a9d8-51d9c83a87896
1927285infliximab-abda 100 MG InjectionSCDdbf738c4-3fac-4422-a9d8-51d9c83a87896
1927290Renflexis 100 MG InjectionSYdbf738c4-3fac-4422-a9d8-51d9c83a87896

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78206-162-01782060162011 VIAL in 1 CARTON (78206-162-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (78206-162-99) 1 vial2021-06-010000-00-00NoNoCurrent
78206-162-99782060162991 in 1 VIALHistorical