FDA.reportPublic FDA data

TOFIDENCE

Product NDC
78206-201
11-digit product format
782060201
Labeler code
78206
Product ID
78206-201_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
200 mg/10mL
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOCILIZUMAB200 mg/10mL

Harmonized Identifiers#

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

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
78206-201-01TOFIDENCE1 in 1 CARTONINJECTION12
78206-201-01TOFIDENCE10 mL in 1 VIAL, SINGLE-DOSEINJECTION102

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
78206-201-01782060201011 VIAL, SINGLE-DOSE in 1 CARTON (78206-201-01) / 10 mL in 1 VIAL, SINGLE-DOSE2025-07-03NoNoCurrent