tyruko

Generic: natalizumab-sztn

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name tyruko
Generic Name natalizumab-sztn
Labeler sandoz inc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

natalizumab 300 mg/15mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-543
Product ID 61314-543_29c4086f-ca52-4f83-9119-bada7ec65482
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761322
Listing Expiration 2027-12-31
Marketing Start 2025-11-17

Pharmacologic Class

Established (EPC)
integrin receptor antagonist [epc]
Mechanism of Action
integrin receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61314543
Hyphenated Format 61314-543

Supplemental Identifiers

RxCUI
2725173 2725180
UNII
3JB47N2Q2P
NUI
N0000175775 N0000175774

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 tyruko (source: ndc)
Generic Name natalizumab-sztn (source: ndc)
Application Number BLA761322 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/15mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (61314-543-94) / 15 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

61314-543-94 1 VIAL, SINGLE-DOSE in 1 CARTON (61314-543-94) / 15 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

natalizumab (300 mg/15mL)

Linked Drug Pages (1)

TYRUKO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "29c4086f-ca52-4f83-9119-bada7ec65482", "openfda": {"nui": ["N0000175775", "N0000175774"], "unii": ["3JB47N2Q2P"], "rxcui": ["2725173", "2725180"], "spl_set_id": ["ef653c36-dd4b-4e71-9d2d-40b8fea24b67"], "pharm_class_epc": ["Integrin Receptor Antagonist [EPC]"], "pharm_class_moa": ["Integrin Receptor Antagonists [MoA]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (61314-543-94)  / 15 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "61314-543-94", "marketing_start_date": "20251117"}], "brand_name": "TYRUKO", "product_id": "61314-543_29c4086f-ca52-4f83-9119-bada7ec65482", "dosage_form": "INJECTION", "pharm_class": ["Integrin Receptor Antagonist [EPC]", "Integrin Receptor Antagonists [MoA]"], "product_ndc": "61314-543", "generic_name": "natalizumab-sztn", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TYRUKO", "active_ingredients": [{"name": "NATALIZUMAB", "strength": "300 mg/15mL"}], "application_number": "BLA761322", "marketing_category": "BLA", "marketing_start_date": "20251117", "listing_expiration_date": "20271231"}