kevzara

Generic: sarilumab

Labeler: sanofi-aventis u.s. llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name kevzara
Generic Name sarilumab
Labeler sanofi-aventis u.s. llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

sarilumab 200 mg/1.14mL

Manufacturer
Sanofi-Aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0024-5922
Product ID 0024-5922_b1eeca31-be2b-4c68-a7c0-220256a2b906
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761037
Listing Expiration 2027-12-31
Marketing Start 2017-05-22

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 00245922
Hyphenated Format 0024-5922

Supplemental Identifiers

UNII
NU90V55F8I
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 kevzara (source: ndc)
Generic Name sarilumab (source: ndc)
Application Number BLA761037 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/1.14mL
source: ndc
Packaging
  • 2 SYRINGE in 1 PACKAGE (0024-5922-01) / 1.14 mL in 1 SYRINGE (0024-5922-00)
  • 2 SYRINGE in 1 PACKAGE (0024-5922-02) / 1.14 mL in 1 SYRINGE
source: ndc

Packages (2)

0024-5922-01 2 SYRINGE in 1 PACKAGE (0024-5922-01) / 1.14 mL in 1 SYRINGE (0024-5922-00) 0024-5922-02 2 SYRINGE in 1 PACKAGE (0024-5922-02) / 1.14 mL in 1 SYRINGE

Ingredients (1)

sarilumab (200 mg/1.14mL)

Linked Drug Pages (1)

KEVZARA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "b1eeca31-be2b-4c68-a7c0-220256a2b906", "openfda": {"nui": ["N0000190478", "N0000190480"], "unii": ["NU90V55F8I"], "spl_set_id": ["827bc01c-d379-4266-a18c-c7f904b76af3"], "pharm_class_epc": ["Interleukin-6 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Interleukin 6 Receptor Antagonists [MoA]"], "manufacturer_name": ["Sanofi-Aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE in 1 PACKAGE (0024-5922-01)  / 1.14 mL in 1 SYRINGE (0024-5922-00)", "package_ndc": "0024-5922-01", "marketing_start_date": "20180413"}, {"sample": false, "description": "2 SYRINGE in 1 PACKAGE (0024-5922-02)  / 1.14 mL in 1 SYRINGE", "package_ndc": "0024-5922-02", "marketing_start_date": "20180413"}], "brand_name": "KEVZARA", "product_id": "0024-5922_b1eeca31-be2b-4c68-a7c0-220256a2b906", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Interleukin 6 Receptor Antagonists [MoA]", "Interleukin-6 Receptor Antagonist [EPC]"], "product_ndc": "0024-5922", "generic_name": "sarilumab", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KEVZARA", "active_ingredients": [{"name": "SARILUMAB", "strength": "200 mg/1.14mL"}], "application_number": "BLA761037", "marketing_category": "BLA", "marketing_start_date": "20170522", "listing_expiration_date": "20271231"}