Actemra ACTPen

Product NDC: 50242-143
11-digit product format: 502420143
Labeler code: 50242
Product ID: 50242-143_7f1b03d3-e0e1-4d90-b588-bb8d3ecb154a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tocilizumab
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Genentech, Inc.
Application: BLA125472
Marketing category: BLA
Marketing start: 2018-11-19
Substance: TOCILIZUMAB
Active strength: 162 mg/.9mL
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 ACTPen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOCILIZUMAB	162 mg/.9mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
I031V2H011	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1441527	Internal RxNorm lookup
1441530	Internal RxNorm lookup
1657974	Internal RxNorm lookup
1657976	Internal RxNorm lookup
1657979	Internal RxNorm lookup
1657980	Internal RxNorm lookup
1657981	Internal RxNorm lookup
1657982	Internal RxNorm lookup
2106073	Internal RxNorm lookup
2106075	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9f5f0f3b-b458-45da-a406-00e2782d440a	Product name	1	20150818
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50242-143-01	Actemra ACTPen	1 in 1 BOX	INJECTION, SOLUTION	1	53
50242-143-01	Actemra ACTPen	0.9 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	0.9	53
50242-143-86	Actemra ACTPen	1 in 1 BOX	INJECTION, SOLUTION	1	53
50242-143-86	Actemra ACTPen	0.9 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	0.9	53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50242-143-01	ML - Milliliter	50242-143	bab420df-cdf6-4219-a86e-1280c51c50f7	1	2019-01-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
tocilizumab	ACTIVE INGREDIENT	I031V2H011	ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	14
tocilizumab	ACTIVE MOIETY	I031V2H011	ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	14
arginine	INACTIVE INGREDIENT	94ZLA3W45F	ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	14
arginine hydrochloride	INACTIVE INGREDIENT	F7LTH1E20Y	ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	14
histidine	INACTIVE INGREDIENT	4QD397987E	ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	14
histidine monohydrochloride monohydrate	INACTIVE INGREDIENT	X573657P6P	ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	14
methionine	INACTIVE INGREDIENT	AE28F7PNPL	ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	14
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	14
sodium phosphate, dibasic, dodecahydrate	INACTIVE INGREDIENT	E1W4N241FO	ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	14
sodium phosphate, monobasic, dihydrate	INACTIVE INGREDIENT	5QWK665956	ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	14
sucrose	INACTIVE INGREDIENT	C151H8M554	ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	14
water	INACTIVE INGREDIENT	059QF0KO0R	ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50242-143	ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION ACTEMRA ACTPEN (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.]	50	Current NDC, Legacy NDC, 4 package rows	20241128_2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACTEMRA	TOCILIZUMAB	Genentech, Inc.	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125472 ndc (product): 50242-143

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125472	Actemra	tocilizumab	351(a)	Rx	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I031V2H011	TOCILIZUMAB	375823-41-9	TOCILIZUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1441530	Actemra 162 MG in 0.9 ML Prefilled Syringe	PSN	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1657980	Actemra 200 MG in 10 ML Injection	PSN	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1657982	Actemra 400 MG in 20 ML Injection	PSN	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1657976	Actemra 80 MG in 4 ML Injection	PSN	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
2106075	Actemra ACTPen 162 MG in 0.9 ML Auto-Injector	PSN	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
2106073	tocilizumab 162 MG in 0.9 ML Auto-Injector	PSN	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1441527	tocilizumab 162 MG in 0.9 ML Prefilled Syringe	PSN	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1657979	tocilizumab 200 MG in 10 ML Injection	PSN	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1657981	tocilizumab 400 MG in 20 ML Injection	PSN	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1657974	tocilizumab 80 MG in 4 ML Injection	PSN	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
2106075	0.9 ML tocilizumab 180 MG/ML Auto-Injector [Actemra]	SBD	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1441530	0.9 ML tocilizumab 180 MG/ML Prefilled Syringe [Actemra]	SBD	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1657980	10 ML tocilizumab 20 MG/ML Injection [Actemra]	SBD	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1657982	20 ML tocilizumab 20 MG/ML Injection [Actemra]	SBD	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1657976	4 ML tocilizumab 20 MG/ML Injection [Actemra]	SBD	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
2106073	0.9 ML tocilizumab 180 MG/ML Auto-Injector	SCD	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1441527	0.9 ML tocilizumab 180 MG/ML Prefilled Syringe	SCD	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1657979	10 ML tocilizumab 20 MG/ML Injection	SCD	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1657981	20 ML tocilizumab 20 MG/ML Injection	SCD	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1657974	4 ML tocilizumab 20 MG/ML Injection	SCD	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
2106075	0.9 ML Actemra 180 MG/ML Auto-Injector	SY	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1441530	Actemra 162 MG per 0.9 ML Prefilled Syringe	SY	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1657980	Actemra 200 MG per 10 ML Injection	SY	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1657982	Actemra 400 MG per 20 ML Injection	SY	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1657976	Actemra 80 MG per 4 ML Injection	SY	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
2106075	Actemra ACTPen 162 MG per 0.9 ML Auto-Injector	SY	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
2106073	tocilizumab 162 MG in 0.9 ML Auto-Injector	SY	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1441527	tocilizumab 162 MG per 0.9 ML Prefilled Syringe	SY	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1657979	tocilizumab 200 MG per 10 ML Injection	SY	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1657981	tocilizumab 400 MG per 20 ML Injection	SY	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53
1657974	tocilizumab 80 MG per 4 ML Injection	SY	2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13	53

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50242-143-01	50242014301	1 SYRINGE, GLASS in 1 BOX (50242-143-01) / .9 mL in 1 SYRINGE, GLASS	2018-11-19	0000-00-00	No	No	Current
50242-143-86	50242014386	1 SYRINGE, GLASS in 1 BOX (50242-143-86) / .9 mL in 1 SYRINGE, GLASS	2018-11-19	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACTEMRA	Genentech, Inc. \| F. Hoffmann-La Roche AG \| Genentech, Inc. (Oceanside) \| Roche Diagnostics GmbH \| Genentech, Inc. (Hillsboro)	2025-12-16	HUMAN PRESCRIPTION DRUG LABEL	53