FDA.reportPublic FDA data

Tofidence

Product NDC
64406-024
Requested package NDC
64406-024-01
11-digit product format
644060024
Labeler code
64406
Product ID
64406-024_2edc5db5-3ecd-451e-bbdd-01fe8db1100b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tocilizumab
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Biogen MA Inc
Application
BLA761354
Marketing category
BLA
Marketing start
2024-05-01
Marketing end
2027-08-01
Substance
TOCILIZUMAB
Active strength
20 mg/mL
Pharmacologic classes
Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tofidence

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOCILIZUMAB20 mg/mL

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
00529b23-850a-42b9-a152-125a95b5242cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
64406-024-01Tofidence1 in 1 CARTONINJECTION110
64406-024-01Tofidence20 mL in 1 VIAL, SINGLE-USEINJECTION2010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64406-024-01ML - Milliliter64406-024a9f0dd78-87cf-4aa8-b21a-81e86edb2e7012024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64406-024TOFIDENCE (TOCILIZUMAB) INJECTION [BIOGEN MA INC.]9Current NDC, 2 package rows20250321_00529b23-850a-42b9-a152-125a95b5242c.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 · 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
TofidenceTOCILIZUMABBiogen MA Inc00529b23-850a-42b9-a152-125a95b5242c2025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761354
ndc (package): 64406-024-01
ndc (product): 64406-024
ndc11 (package): 64406002401

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761354Tofidencetocilizumab-bavi351(k) BiosimilarRx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2680287tocilizumab-bavi 200 MG in 10 ML InjectionPSN00529b23-850a-42b9-a152-125a95b5242c10
2680296tocilizumab-bavi 400 MG in 20 ML InjectionPSN00529b23-850a-42b9-a152-125a95b5242c10
2680298tocilizumab-bavi 80 MG in 4 ML InjectionPSN00529b23-850a-42b9-a152-125a95b5242c10
2680294Tofidence 200 MG in 10 ML InjectionPSN00529b23-850a-42b9-a152-125a95b5242c10
2680297Tofidence 400 MG in 20 ML InjectionPSN00529b23-850a-42b9-a152-125a95b5242c10
2680299Tofidence 80 MG in 4 ML InjectionPSN00529b23-850a-42b9-a152-125a95b5242c10
268029410 ML tocilizumab-bavi 20 MG/ML Injection [Tofidence]SBD00529b23-850a-42b9-a152-125a95b5242c10
268029720 ML tocilizumab-bavi 20 MG/ML Injection [Tofidence]SBD00529b23-850a-42b9-a152-125a95b5242c10
26802994 ML tocilizumab-bavi 20 MG/ML Injection [Tofidence]SBD00529b23-850a-42b9-a152-125a95b5242c10
268028710 ML tocilizumab-bavi 20 MG/ML InjectionSCD00529b23-850a-42b9-a152-125a95b5242c10
268029620 ML tocilizumab-bavi 20 MG/ML InjectionSCD00529b23-850a-42b9-a152-125a95b5242c10
26802984 ML tocilizumab-bavi 20 MG/ML InjectionSCD00529b23-850a-42b9-a152-125a95b5242c10
268029410 ML Tofidence 20 MG/ML InjectionSY00529b23-850a-42b9-a152-125a95b5242c10
268029720 ML Tofidence 20 MG/ML InjectionSY00529b23-850a-42b9-a152-125a95b5242c10
26802994 ML Tofidence 20 MG/ML InjectionSY00529b23-850a-42b9-a152-125a95b5242c10
2680287tocilizumab-bavi 200 MG per 10 ML InjectionSY00529b23-850a-42b9-a152-125a95b5242c10
2680296tocilizumab-bavi 400 MG per 20 ML InjectionSY00529b23-850a-42b9-a152-125a95b5242c10
2680298tocilizumab-bavi 80 MG per 4 ML InjectionSY00529b23-850a-42b9-a152-125a95b5242c10
2680294Tofidence 200 MG per 10 ML InjectionSY00529b23-850a-42b9-a152-125a95b5242c10
2680297Tofidence 400 MG per 20 ML InjectionSY00529b23-850a-42b9-a152-125a95b5242c10
2680299Tofidence 80 MG per 4 ML InjectionSY00529b23-850a-42b9-a152-125a95b5242c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64406-024-01644060024011 VIAL, SINGLE-USE in 1 CARTON (64406-024-01) / 20 mL in 1 VIAL, SINGLE-USE2024-05-012027-08-01NoNoHistorical