FDA.reportPublic FDA data

Zinplava 1000 MG in 40 ML Injection

RxCUI
1855057
RxNorm name
Zinplava 1000 MG in 40 ML Injection
Display name
Zinplava 1000 MG in 40 ML Injection
Full name
Zinplava 1000 MG in 40 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:08

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761046Zinplavabezlotoxumab351(a)Rx2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZINPLAVABEZLOTOXUMABMerck Sharp & Dohme LLC8f479bfe-2bfa-4cc5-9aee-1357364480b02024-11-12Warnings, Adverse reactionsExact identifier
rxcui: 1855057

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
8f479bfe-2bfa-4cc5-9aee-1357364480b0Zinplava 1000 MG in 40 ML InjectionPSN12These 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: 201620241112
8f479bfe-2bfa-4cc5-9aee-1357364480b040 ML bezlotoxumab 25 MG/ML Injection [Zinplava]SBD12These 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: 201620241112
8f479bfe-2bfa-4cc5-9aee-1357364480b0Zinplava 1000 MG per 40 ML InjectionSY12These 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: 201620241112
8f479bfe-2bfa-4cc5-9aee-1357364480b040 ML Zinplava 25 MG/ML InjectionSY12These 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: 201620241112