FDA.reportPublic FDA data

pemgarda

Product NDC
81960-031
11-digit product format
819600031
Labeler code
81960
Product ID
81960-031_4b1b8d43-0bf4-849a-e063-6294a90abfb4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pemivibart
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Invivyd, Inc
Application
EUA000122
Marketing category
EMERGENCY USE AUTHORIZATION
Marketing start
2024-03-22
Substance
PEMIVIBART
Active strength
125 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
pemgarda
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEMIVIBART125 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
557S3L3FAPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2677805Internal RxNorm lookup
2677811Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0bdc20a9-791f-9a06-e063-6394a90a84ccAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81960-031-03pemgarda4 mL in 1 VIAL, SINGLE-DOSEINJECTION410
81960-031-03pemgarda9 in 1 CARTONINJECTION910

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81960-031-03ML - Milliliter81960-031e46ebbec-49d4-4fdd-9219-c4bbd5c5f32b12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81960-031PEMGARDA (PEMIVIBART) INJECTION [INVIVYD, INC]2Current NDC, 2 package rows20240324_0bdc20a9-791f-9a06-e063-6394a90a84cc.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
pemgardaPEMIVIBARTInvivyd, Inc0bdc20a9-791f-9a06-e063-6394a90a84cc2025-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: EUA000122
ndc (product): 81960-031

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2677811PEMGARDA 500 MG in 4 ML Injection (EUA)PSN0bdc20a9-791f-9a06-e063-6394a90a84cc10
2677805pemivibart 500 MG in 4 ML Injection (EUA)PSN0bdc20a9-791f-9a06-e063-6394a90a84cc10
26778114 ML pemivibart 125 MG/ML Injection [Pemgarda]SBD0bdc20a9-791f-9a06-e063-6394a90a84cc10
26778054 ML pemivibart 125 MG/ML InjectionSCD0bdc20a9-791f-9a06-e063-6394a90a84cc10
2677811Pemgarda 500 MG per 4 ML Injection (EUA)SY0bdc20a9-791f-9a06-e063-6394a90a84cc10
2677805pemivibart 500 MG per 4 ML Injection (EUA)SY0bdc20a9-791f-9a06-e063-6394a90a84cc10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81960-031-03819600031039 VIAL, SINGLE-DOSE in 1 CARTON (81960-031-03) / 4 mL in 1 VIAL, SINGLE-DOSE2024-03-22NoNoCurrent