FDA.reportPublic FDA data

ELFABRIO

Product NDC
10122-165
11-digit product format
101220165
Labeler code
10122
Product ID
10122-165_ca12aa63-7344-4996-bfb4-d2289c245f4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pegunigalsidase alfa
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Chiesi USA, Inc.
Application
BLA761161
Marketing category
BLA
Marketing start
2023-05-23
Substance
PEGUNIGALSIDASE ALFA
Active strength
5 mg/2.5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEGUNIGALSIDASE ALFA5 mg/2.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8M7V7Q6537Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2637456Internal RxNorm lookup
2637462Internal RxNorm lookup
2676759Internal RxNorm lookup
2676760Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6fb674bf-744e-431f-92ef-b2a5a66c8cf3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8ad7e858-820a-443f-a8eb-35006a7aeb0dProduct name120231025

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10122-165-02ELFABRIO2.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE2.57
10122-165-02ELFABRIO1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10122-165-02ML - Milliliter10122-1653e09ba3e-402a-448b-b962-31e7bbc5f23c12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10122-165ELFABRIO (PEGUNIGALSIDASE ALFA) INJECTION, SOLUTION, CONCENTRATE [CHIESI USA, INC.]7Current NDC, 2 package rows20240709_6fb674bf-744e-431f-92ef-b2a5a66c8cf3.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
ELFABRIOPEGUNIGALSIDASE ALFAChiesi USA, Inc.6fb674bf-744e-431f-92ef-b2a5a66c8cf32024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761161
ndc (product): 10122-165

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761161Elfabriopegunigalsidase alfa-iwxj351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637462ELFABRIO 20 MG in 10 ML InjectionPSN6fb674bf-744e-431f-92ef-b2a5a66c8cf37
2676760ELFABRIO 5 MG in 2.5 ML InjectionPSN6fb674bf-744e-431f-92ef-b2a5a66c8cf37
2637456pegunigalsidase alfa-iwxj 20 MG in 10 ML InjectionPSN6fb674bf-744e-431f-92ef-b2a5a66c8cf37
2676759pegunigalsidase alfa-iwxj 5 MG in 2.5 ML InjectionPSN6fb674bf-744e-431f-92ef-b2a5a66c8cf37
263746210 ML pegunigalsidase alfa-iwxj 2 MG/ML Injection [Elfabrio]SBD6fb674bf-744e-431f-92ef-b2a5a66c8cf37
26767602.5 ML pegunigalsidase alfa-iwxj 2 MG/ML Injection [Elfabrio]SBD6fb674bf-744e-431f-92ef-b2a5a66c8cf37
263745610 ML pegunigalsidase alfa-iwxj 2 MG/ML InjectionSCD6fb674bf-744e-431f-92ef-b2a5a66c8cf37
26767592.5 ML pegunigalsidase alfa-iwxj 2 MG/ML InjectionSCD6fb674bf-744e-431f-92ef-b2a5a66c8cf37
263746210 ML Elfabrio 2 MG/ML InjectionSY6fb674bf-744e-431f-92ef-b2a5a66c8cf37
26767602.5 ML Elfabrio 2 MG/ML InjectionSY6fb674bf-744e-431f-92ef-b2a5a66c8cf37
2637462Elfabrio 20 MG per 10 ML InjectionSY6fb674bf-744e-431f-92ef-b2a5a66c8cf37
2676760Elfabrio 5 MG per 2.5 ML InjectionSY6fb674bf-744e-431f-92ef-b2a5a66c8cf37
2637456pegunigalsidase alfa-iwxj 20 MG per 10 ML InjectionSY6fb674bf-744e-431f-92ef-b2a5a66c8cf37
2676759pegunigalsidase alfa-iwxj 5 MG per 2.5 ML InjectionSY6fb674bf-744e-431f-92ef-b2a5a66c8cf37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
10122-165-02101220165021 VIAL, SINGLE-DOSE in 1 CARTON (10122-165-02) / 2.5 mL in 1 VIAL, SINGLE-DOSE2024-07-08NoNoCurrent