TZIELD
These highlights do not include all the information needed to use TZIELD safely and effectively. See full prescribing information for TZIELD. TZIELD (teplizumab-mzwv) injection, for intravenous use Initial U.S. Approval: 2022
Approved
Approval ID
e8a39a5f-139c-4510-9777-71cbb00138fa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2023
Manufacturers
FDA
Provention Bio, Inc.
DUNS: 080768105
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
teplizumab-mzwv
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73650-316
Application NumberBLA761183
Product Classification
M
Marketing Category
C73585
G
Generic Name
teplizumab-mzwv
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 8, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATEInactive
Quantity: 0.26 mg in 1 mL
Code: E1W4N241FO
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Quantity: 1.13 mg in 1 mL
Code: 5QWK665956
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TEPLIZUMABActive
Quantity: 1 mg in 1 mL
Code: S4M959U2IJ
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 8.78 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.05 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT