actemra

Generic: tocilizumab

Labeler: genentech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name actemra
Generic Name tocilizumab
Labeler genentech, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

tocilizumab 162 mg/.9mL

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-138
Product ID 50242-138_7f1b03d3-e0e1-4d90-b588-bb8d3ecb154a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125472
Listing Expiration 2026-12-31
Marketing Start 2013-10-21

Pharmacologic Class

Established (EPC)
interleukin-6 receptor antagonist [epc]
Mechanism of Action
interleukin 6 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242138
Hyphenated Format 50242-138

Supplemental Identifiers

RxCUI
1441527 1441530 1657974 1657976 1657979 1657980 1657981 1657982 2106073 2106075
UNII
I031V2H011
NUI
N0000190478 N0000190480

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name actemra (source: ndc)
Generic Name tocilizumab (source: ndc)
Application Number BLA125472 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 162 mg/.9mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 BOX (50242-138-01) / .9 mL in 1 SYRINGE, GLASS
  • 1 SYRINGE, GLASS in 1 BOX (50242-138-86) / .9 mL in 1 SYRINGE, GLASS
source: ndc

Packages (2)

50242-138-01 1 SYRINGE, GLASS in 1 BOX (50242-138-01) / .9 mL in 1 SYRINGE, GLASS 50242-138-86 1 SYRINGE, GLASS in 1 BOX (50242-138-86) / .9 mL in 1 SYRINGE, GLASS

Ingredients (1)

tocilizumab (162 mg/.9mL)

Linked Drug Pages (1)

ACTEMRA, Actemra, Actemra ACTPen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "7f1b03d3-e0e1-4d90-b588-bb8d3ecb154a", "openfda": {"nui": ["N0000190478", "N0000190480"], "unii": ["I031V2H011"], "rxcui": ["1441527", "1441530", "1657974", "1657976", "1657979", "1657980", "1657981", "1657982", "2106073", "2106075"], "spl_set_id": ["2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13"], "pharm_class_epc": ["Interleukin-6 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Interleukin 6 Receptor Antagonists [MoA]"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 BOX (50242-138-01)  / .9 mL in 1 SYRINGE, GLASS", "package_ndc": "50242-138-01", "marketing_start_date": "20131021"}, {"sample": true, "description": "1 SYRINGE, GLASS in 1 BOX (50242-138-86)  / .9 mL in 1 SYRINGE, GLASS", "package_ndc": "50242-138-86", "marketing_start_date": "20131021"}], "brand_name": "Actemra", "product_id": "50242-138_7f1b03d3-e0e1-4d90-b588-bb8d3ecb154a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Interleukin 6 Receptor Antagonists [MoA]", "Interleukin-6 Receptor Antagonist [EPC]"], "product_ndc": "50242-138", "generic_name": "tocilizumab", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Actemra", "active_ingredients": [{"name": "TOCILIZUMAB", "strength": "162 mg/.9mL"}], "application_number": "BLA125472", "marketing_category": "BLA", "marketing_start_date": "20131021", "listing_expiration_date": "20261231"}