rystiggo

Generic: rozanolixizumab

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

Drug Facts

Product Profile

Brand Name rystiggo
Generic Name rozanolixizumab
Labeler ucb, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

rozanolixizumab 140 mg/mL

Manufacturer
UCB, Inc.

Identifiers & Regulatory

Product NDC 50474-982
Product ID 50474-982_48d5f5c1-c45c-cb63-e063-6394a90a31c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761286
Listing Expiration 2027-12-31
Marketing Start 2024-06-14

Pharmacologic Class

Established (EPC)
neonatal fc receptor blocker [epc]
Mechanism of Action
neonatal fc receptor blockers [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50474982
Hyphenated Format 50474-982

Supplemental Identifiers

RxCUI
2642288 2642294 2685614 2685615 2685616 2685617 2685618 2685619
UNII
P7186074QC
NUI
N0000194004 N0000194005

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 rystiggo (source: ndc)
Generic Name rozanolixizumab (source: ndc)
Application Number BLA761286 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 140 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (50474-982-84) / 4 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

50474-982-84 1 VIAL, GLASS in 1 CARTON (50474-982-84) / 4 mL in 1 VIAL, GLASS

Ingredients (1)

rozanolixizumab (140 mg/mL)

Linked Drug Pages (1)

RYSTIGGO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "48d5f5c1-c45c-cb63-e063-6394a90a31c8", "openfda": {"nui": ["N0000194004", "N0000194005"], "unii": ["P7186074QC"], "rxcui": ["2642288", "2642294", "2685614", "2685615", "2685616", "2685617", "2685618", "2685619"], "spl_set_id": ["3c0eb8c2-c042-4954-b451-3baa77f5e6d1"], "pharm_class_epc": ["Neonatal Fc Receptor Blocker [EPC]"], "pharm_class_moa": ["Neonatal Fc Receptor Blockers [MoA]"], "manufacturer_name": ["UCB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (50474-982-84)  / 4 mL in 1 VIAL, GLASS", "package_ndc": "50474-982-84", "marketing_start_date": "20240715"}], "brand_name": "RYSTIGGO", "product_id": "50474-982_48d5f5c1-c45c-cb63-e063-6394a90a31c8", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Neonatal Fc Receptor Blocker [EPC]", "Neonatal Fc Receptor Blockers [MoA]"], "product_ndc": "50474-982", "generic_name": "ROZANOLIXIZUMAB", "labeler_name": "UCB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RYSTIGGO", "active_ingredients": [{"name": "ROZANOLIXIZUMAB", "strength": "140 mg/mL"}], "application_number": "BLA761286", "marketing_category": "BLA", "marketing_start_date": "20240614", "listing_expiration_date": "20271231"}