FDA.reportPublic FDA data

ZINPLAVA

Product NDC
0006-3025
Requested package NDC
0006-3025-00
11-digit product format
000063025
Labeler code
0006
Product ID
0006-3025_1302e606-55e6-42a4-aab1-4d16f1823397
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
ZINPLAVA
Listing expiration
2027-12-31

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
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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761046Zinplavabezlotoxumab351(a)Rx2026-10-01

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 formatDescriptionMarketing 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