FDA.reportPublic FDA data

TOFIDENCE

Product NDC
78206-202
11-digit product format
782060202
Labeler code
78206
Product ID
78206-202_2fe7ea85-3cb6-4855-9f6e-719611650564
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOCILIZUMAB
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Organon LLC
Application
BLA761354
Marketing category
BLA
Marketing start
2025-07-03
Substance
TOCILIZUMAB
Active strength
400 mg/20mL
Pharmacologic classes
Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TOFIDENCE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOCILIZUMAB400 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
I031V2H011Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2680287Internal RxNorm lookup
2680294Internal RxNorm lookup
2680296Internal RxNorm lookup
2680297Internal RxNorm lookup
2680298Internal RxNorm lookup
2680299Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1ab3207a-ebfe-4565-9ce5-3a1538815c83Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9f5f0f3b-b458-45da-a406-00e2782d440aProduct name120150818
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78206-202-01TOFIDENCE1 in 1 CARTONINJECTION12
78206-202-01TOFIDENCE20 mL in 1 VIAL, SINGLE-DOSEINJECTION202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-202-01ML - Milliliter78206-202845d534f-9721-4957-94e3-ec73581dd59212026-04-20

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOFIDENCETOCILIZUMABOrganon LLC1ab3207a-ebfe-4565-9ce5-3a1538815c832026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761354
ndc (product): 78206-202
TofidenceTOCILIZUMABBiogen MA Inc00529b23-850a-42b9-a152-125a95b5242c2025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761354

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761354Tofidencetocilizumab-bavi351(k) BiosimilarRx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2680287tocilizumab-bavi 200 MG in 10 ML InjectionPSN1ab3207a-ebfe-4565-9ce5-3a1538815c832
2680296tocilizumab-bavi 400 MG in 20 ML InjectionPSN1ab3207a-ebfe-4565-9ce5-3a1538815c832
2680298tocilizumab-bavi 80 MG in 4 ML InjectionPSN1ab3207a-ebfe-4565-9ce5-3a1538815c832
2680294Tofidence 200 MG in 10 ML InjectionPSN1ab3207a-ebfe-4565-9ce5-3a1538815c832
2680297Tofidence 400 MG in 20 ML InjectionPSN1ab3207a-ebfe-4565-9ce5-3a1538815c832
2680299Tofidence 80 MG in 4 ML InjectionPSN1ab3207a-ebfe-4565-9ce5-3a1538815c832
268029410 ML tocilizumab-bavi 20 MG/ML Injection [Tofidence]SBD1ab3207a-ebfe-4565-9ce5-3a1538815c832
268029720 ML tocilizumab-bavi 20 MG/ML Injection [Tofidence]SBD1ab3207a-ebfe-4565-9ce5-3a1538815c832
26802994 ML tocilizumab-bavi 20 MG/ML Injection [Tofidence]SBD1ab3207a-ebfe-4565-9ce5-3a1538815c832
268028710 ML tocilizumab-bavi 20 MG/ML InjectionSCD1ab3207a-ebfe-4565-9ce5-3a1538815c832
268029620 ML tocilizumab-bavi 20 MG/ML InjectionSCD1ab3207a-ebfe-4565-9ce5-3a1538815c832
26802984 ML tocilizumab-bavi 20 MG/ML InjectionSCD1ab3207a-ebfe-4565-9ce5-3a1538815c832
268029410 ML Tofidence 20 MG/ML InjectionSY1ab3207a-ebfe-4565-9ce5-3a1538815c832
268029720 ML Tofidence 20 MG/ML InjectionSY1ab3207a-ebfe-4565-9ce5-3a1538815c832
26802994 ML Tofidence 20 MG/ML InjectionSY1ab3207a-ebfe-4565-9ce5-3a1538815c832
2680287tocilizumab-bavi 200 MG per 10 ML InjectionSY1ab3207a-ebfe-4565-9ce5-3a1538815c832
2680296tocilizumab-bavi 400 MG per 20 ML InjectionSY1ab3207a-ebfe-4565-9ce5-3a1538815c832
2680298tocilizumab-bavi 80 MG per 4 ML InjectionSY1ab3207a-ebfe-4565-9ce5-3a1538815c832
2680294Tofidence 200 MG per 10 ML InjectionSY1ab3207a-ebfe-4565-9ce5-3a1538815c832
2680297Tofidence 400 MG per 20 ML InjectionSY1ab3207a-ebfe-4565-9ce5-3a1538815c832
2680299Tofidence 80 MG per 4 ML InjectionSY1ab3207a-ebfe-4565-9ce5-3a1538815c832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
78206-202-01782060202011 VIAL, SINGLE-DOSE in 1 CARTON (78206-202-01) / 20 mL in 1 VIAL, SINGLE-DOSE2025-07-03NoNoCurrent