FDA.reportPublic FDA data

Tofidence

Product NDC
64406-022
11-digit product format
644060022
Labeler code
64406
Product ID
64406-022_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

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 · 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 (product): 64406-022

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
64406-022-01Tofidence4 mL in 1 VIAL, SINGLE-USEINJECTION410
64406-022-01Tofidence1 in 1 CARTONINJECTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64406-022-01ML - Milliliter64406-022f8d5e98b-d4d8-4b07-8838-9c4586e6280d12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64406-022TOFIDENCE (TOCILIZUMAB) INJECTION [BIOGEN MA INC.]9Current NDC, 2 package rows20250321_00529b23-850a-42b9-a152-125a95b5242c.zip

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
64406-022-01644060022011 VIAL, SINGLE-USE in 1 CARTON (64406-022-01) / 4 mL in 1 VIAL, SINGLE-USE2024-05-012027-08-01NoNoHistorical