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RYSTIGGO

These highlights do not include all the information needed to use RYSTIGGO safely and effectively. See full prescribing information for RYSTIGGO. RYSTIGGO (rozanolixizumab-noli) injection, for subcutaneous use Initial U.S. Approval: 2023

Approved
Approval ID

3c0eb8c2-c042-4954-b451-3baa77f5e6d1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 30, 2023

Manufacturers
FDA

UCB, Inc.

DUNS: 028526403

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ROZANOLIXIZUMAB

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50474-981
Application NumberBLA761286
Product Classification
M
Marketing Category
C73585
G
Generic Name
ROZANOLIXIZUMAB
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMay 6, 2025
FDA Product Classification

INGREDIENTS (1)

ROZANOLIXIZUMABActive
Quantity: 140 mg in 1 mL
Code: P7186074QC
Classification: ACTIB

ROZANOLIXIZUMAB

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50474-982
Application NumberBLA761286
Product Classification
M
Marketing Category
C73585
G
Generic Name
ROZANOLIXIZUMAB
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMay 6, 2025
FDA Product Classification

INGREDIENTS (1)

ROZANOLIXIZUMABActive
Quantity: 140 mg in 1 mL
Code: P7186074QC
Classification: ACTIB

ROZANOLIXIZUMAB

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50474-983
Application NumberBLA761286
Product Classification
M
Marketing Category
C73585
G
Generic Name
ROZANOLIXIZUMAB
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMay 6, 2025
FDA Product Classification

INGREDIENTS (1)

ROZANOLIXIZUMABActive
Quantity: 140 mg in 1 mL
Code: P7186074QC
Classification: ACTIB

ROZANOLIXIZUMAB

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50474-980
Application NumberBLA761286
Product Classification
M
Marketing Category
C73585
G
Generic Name
ROZANOLIXIZUMAB
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJune 30, 2023
FDA Product Classification

INGREDIENTS (2)

ROZANOLIXIZUMABActive
Quantity: 140 mg in 1 mL
Code: P7186074QC
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT

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