ZINPLAVA
These highlights do not include all the information needed to use ZINPLAVA safely and effectively. See full prescribing information for ZINPLAVA. ZINPLAVA™ (bezlotoxumab) injection, for intravenous use Initial U.S. Approval: 2016
Approved
Approval ID
8f479bfe-2bfa-4cc5-9aee-1357364480b0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 26, 2023
Manufacturers
FDA
Merck Sharp & Dohme LLC
DUNS: 118446553
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bezlotoxumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0006-3025
Application NumberBLA761046
Product Classification
M
Marketing Category
C73585
G
Generic Name
bezlotoxumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 26, 2023
FDA Product Classification
INGREDIENTS (8)
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.8 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
PENTETIC ACIDInactive
Quantity: 0.0078 mg in 1 mL
Code: 7A314HQM0I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
bezlotoxumabActive
Quantity: 25 mg in 1 mL
Code: 4H5YMK1H2E
Classification: ACTIB
POLYSORBATE 80Inactive
Quantity: 0.25 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.77 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 4.75 mg in 1 mL
Code: B22547B95K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT