FDA.reportPublic FDA data

ZINPLAVA

Product NDC
0006-3025
11-digit product format
000063025
Labeler code
0006
Product ID
0006-3025_12338d29-efb0-4943-b5f5-826350e9ec46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bezlotoxumab
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Merck Sharp & Dohme LLC
Application
BLA761046
Marketing category
BLA
Marketing start
2016-10-21
Substance
BEZLOTOXUMAB
Active strength
25 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZINPLAVA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BEZLOTOXUMAB25 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4H5YMK1H2EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1855052Internal RxNorm lookup
1855057Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8f479bfe-2bfa-4cc5-9aee-1357364480b0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3721525f-580a-45de-b4d6-2b95879548f9Product name120161213

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0006-3025-002024-01-30C16284748780-11030e365-0c65-111a-e063-dadaa90a10e2These 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
0006-3025-002024-01-30C16284748780-11030e365-0c65-111a-e063-dadaa90a10e2These 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-3025-00ZINPLAVA1 in 1 CARTONINJECTION, SOLUTION112
0006-3025-01ZINPLAVA40 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION4012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-3025-00ML - Milliliter0006-30251d828eb6-22a3-47b3-8f35-8296b548574d12017-03-06
0006-3025-01ML - Milliliter0006-3025c49683bf-9ea0-4112-ae51-8384b9661fd512018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-3025ZINPLAVA (BEZLOTOXUMAB) INJECTION, SOLUTION [MERCK SHARP & DOHME LLC]11Current NDC, Legacy NDC, 2 package rows20241129_8f479bfe-2bfa-4cc5-9aee-1357364480b0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
application number: BLA761046
ndc (product): 0006-3025

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761046Zinplavabezlotoxumab351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1855052bezlotoxumab 1000 MG in 40 ML InjectionPSN8f479bfe-2bfa-4cc5-9aee-1357364480b012
1855057Zinplava 1000 MG in 40 ML InjectionPSN8f479bfe-2bfa-4cc5-9aee-1357364480b012
185505740 ML bezlotoxumab 25 MG/ML Injection [Zinplava]SBD8f479bfe-2bfa-4cc5-9aee-1357364480b012
185505240 ML bezlotoxumab 25 MG/ML InjectionSCD8f479bfe-2bfa-4cc5-9aee-1357364480b012
185505740 ML Zinplava 25 MG/ML InjectionSY8f479bfe-2bfa-4cc5-9aee-1357364480b012
1855052bezlotoxumab 1000 MG per 40 ML InjectionSY8f479bfe-2bfa-4cc5-9aee-1357364480b012
1855057Zinplava 1000 MG per 40 ML InjectionSY8f479bfe-2bfa-4cc5-9aee-1357364480b012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-3025-00000063025001 VIAL, SINGLE-DOSE in 1 CARTON (0006-3025-00) / 40 mL in 1 VIAL, SINGLE-DOSE (0006-3025-01) 2016-10-210000-00-00NoNoCurrent
0006-3025-010000630250140 mL in 1 VIAL, SINGLE-DOSE40 mlHistorical