tyenne

Generic: tocilizumab-aazg

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name tyenne
Generic Name tocilizumab-aazg
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

tocilizumab 200 mg/10mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-592
Product ID 65219-592_c6e5034e-6d33-4c6f-bb0e-d03bea292c3a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761275
Listing Expiration 2026-12-31
Marketing Start 2024-04-15

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 65219592
Hyphenated Format 65219-592

Supplemental Identifiers

RxCUI
2679431 2679438 2679440 2679441 2679442 2679443
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 tyenne (source: ndc)
Generic Name tocilizumab-aazg (source: ndc)
Application Number BLA761275 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-592-10) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

65219-592-10 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-592-10) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

tocilizumab (200 mg/10mL)

Linked Drug Pages (1)

TYENNE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c6e5034e-6d33-4c6f-bb0e-d03bea292c3a", "openfda": {"nui": ["N0000190478", "N0000190480"], "unii": ["I031V2H011"], "rxcui": ["2679431", "2679438", "2679440", "2679441", "2679442", "2679443"], "spl_set_id": ["e400bbe6-43c5-4de6-82b9-cb44ce3cd906"], "pharm_class_epc": ["Interleukin-6 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Interleukin 6 Receptor Antagonists [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (65219-592-10)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65219-592-10", "marketing_start_date": "20240415"}], "brand_name": "TYENNE", "product_id": "65219-592_c6e5034e-6d33-4c6f-bb0e-d03bea292c3a", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Interleukin 6 Receptor Antagonists [MoA]", "Interleukin-6 Receptor Antagonist [EPC]"], "product_ndc": "65219-592", "generic_name": "Tocilizumab-aazg", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TYENNE", "active_ingredients": [{"name": "TOCILIZUMAB", "strength": "200 mg/10mL"}], "application_number": "BLA761275", "marketing_category": "BLA", "marketing_start_date": "20240415", "listing_expiration_date": "20261231"}