FDA.reportPublic FDA data

ACTEMRA

Product NDC
50242-137
11-digit product format
502420137
Labeler code
50242
Product ID
50242-137_7f1b03d3-e0e1-4d90-b588-bb8d3ecb154a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tocilizumab
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Genentech, Inc.
Application
BLA125276
Marketing category
BLA
Marketing start
2010-01-08
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
ACTEMRA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOCILIZUMAB400 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI031V2H011
Rxcui1441527, 1441530, 1657974, 1657976, 1657979, 1657980, 1657981, 1657982, 2106073, 2106075

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
50242-137-01ACTEMRA20 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION, CONCENTRATE2053
50242-137-01ACTEMRA1 in 1 BOXINJECTION, SOLUTION, CONCENTRATE153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-137-01ML - Milliliter50242-1377efd0636-f323-4c36-9c71-4851449a445112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
tocilizumabACTIVE INGREDIENTI031V2H011ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]14
tocilizumabACTIVE MOIETYI031V2H011ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]14
arginineINACTIVE INGREDIENT94ZLA3W45FACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]14
arginine hydrochlorideINACTIVE INGREDIENTF7LTH1E20YACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]14
histidineINACTIVE INGREDIENT4QD397987EACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]14
histidine monohydrochloride monohydrateINACTIVE INGREDIENTX573657P6PACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]14
methionineINACTIVE INGREDIENTAE28F7PNPLACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]14
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]14
sodium phosphate, dibasic, dodecahydrateINACTIVE INGREDIENTE1W4N241FOACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]14
sodium phosphate, monobasic, dihydrateINACTIVE INGREDIENT5QWK665956ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]14
sucroseINACTIVE INGREDIENTC151H8M554ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]14
waterINACTIVE INGREDIENT059QF0KO0RACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-137ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION ACTEMRA ACTPEN (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]50Current NDC, Legacy NDC, 2 package rows20241128_2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1441530Actemra 162 MG in 0.9 ML Prefilled SyringePSN2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
1657980Actemra 200 MG in 10 ML InjectionPSN2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
1657982Actemra 400 MG in 20 ML InjectionPSN2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
1657976Actemra 80 MG in 4 ML InjectionPSN2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
2106075Actemra ACTPen 162 MG in 0.9 ML Auto-InjectorPSN2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
2106073tocilizumab 162 MG in 0.9 ML Auto-InjectorPSN2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
1441527tocilizumab 162 MG in 0.9 ML Prefilled SyringePSN2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
1657979tocilizumab 200 MG in 10 ML InjectionPSN2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
1657981tocilizumab 400 MG in 20 ML InjectionPSN2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
1657974tocilizumab 80 MG in 4 ML InjectionPSN2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
21060750.9 ML tocilizumab 180 MG/ML Auto-Injector [Actemra]SBD2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
14415300.9 ML tocilizumab 180 MG/ML Prefilled Syringe [Actemra]SBD2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
165798010 ML tocilizumab 20 MG/ML Injection [Actemra]SBD2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
165798220 ML tocilizumab 20 MG/ML Injection [Actemra]SBD2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
16579764 ML tocilizumab 20 MG/ML Injection [Actemra]SBD2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
21060730.9 ML tocilizumab 180 MG/ML Auto-InjectorSCD2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
14415270.9 ML tocilizumab 180 MG/ML Prefilled SyringeSCD2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
165797910 ML tocilizumab 20 MG/ML InjectionSCD2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
165798120 ML tocilizumab 20 MG/ML InjectionSCD2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
16579744 ML tocilizumab 20 MG/ML InjectionSCD2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
21060750.9 ML Actemra 180 MG/ML Auto-InjectorSY2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
1441530Actemra 162 MG per 0.9 ML Prefilled SyringeSY2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
1657980Actemra 200 MG per 10 ML InjectionSY2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
1657982Actemra 400 MG per 20 ML InjectionSY2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
1657976Actemra 80 MG per 4 ML InjectionSY2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
2106075Actemra ACTPen 162 MG per 0.9 ML Auto-InjectorSY2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
2106073tocilizumab 162 MG in 0.9 ML Auto-InjectorSY2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
1441527tocilizumab 162 MG per 0.9 ML Prefilled SyringeSY2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
1657979tocilizumab 200 MG per 10 ML InjectionSY2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
1657981tocilizumab 400 MG per 20 ML InjectionSY2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353
1657974tocilizumab 80 MG per 4 ML InjectionSY2e5365ff-cb2a-4b16-b2c7-e35c6bf2de1353

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50242-137-01502420137011 VIAL, SINGLE-USE in 1 BOX (50242-137-01) / 20 mL in 1 VIAL, SINGLE-USE2010-01-080000-00-00NoNoCurrent