FDA.reportPublic FDA data

Tofidence

Product NDC
64406-024
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 Identifiers#

Field, Values table
FieldValues
UniiI031V2H011
Rxcui2680287, 2680294, 2680296, 2680297, 2680298, 2680299

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

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