FDA.reportPublic FDA data

Loargys

Product NDC
81583-102
11-digit product format
815830102
Labeler code
81583
Product ID
81583-102_d5ceabf2-43a0-4746-9371-d98a39cf6cfc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pegzilarginase-nbln
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Immedica Pharma US Inc.
Application
BLA761211
Marketing category
BLA
Marketing start
2026-03-09
Substance
PEGZILARGINASE
Active strength
2 mg/.4mL
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
Loargys
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEGZILARGINASE2 mg/.4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4YV4KW88GDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2738655Internal RxNorm lookup
2738662Internal RxNorm lookup
2738664Internal RxNorm lookup
2738665Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d5ceabf2-43a0-4746-9371-d98a39cf6cfcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81583-102-01Loargys1 in 1 CARTONINJECTION11
81583-102-01Loargys0.4 mL in 1 VIALINJECTION0.41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81583-102-01ML - Milliliter81583-1028e1995e8-023d-499c-8290-dbd9cc0ad4eb12026-03-17

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
LoargysPEGZILARGINASE-NBLNImmedica Pharma US Inc.d5ceabf2-43a0-4746-9371-d98a39cf6cfc2026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761211
ndc (product): 81583-102

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761211Loargyspegzilarginase-nbln351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2738665Loargys 2 MG in 0.4 ML InjectionPSNd5ceabf2-43a0-4746-9371-d98a39cf6cfc1
2738662Loargys 5 MG in 1 ML InjectionPSNd5ceabf2-43a0-4746-9371-d98a39cf6cfc1
2738664pegzilarginase-nbln 2 MG in 0.4 ML InjectionPSNd5ceabf2-43a0-4746-9371-d98a39cf6cfc1
2738655pegzilarginase-nbln 5 MG in 1 ML InjectionPSNd5ceabf2-43a0-4746-9371-d98a39cf6cfc1
27386650.4 ML pegzilarginase-nbln 5 MG/ML Injection [Loargys]SBDd5ceabf2-43a0-4746-9371-d98a39cf6cfc1
27386621 ML pegzilarginase-nbln 5 MG/ML Injection [Loargys]SBDd5ceabf2-43a0-4746-9371-d98a39cf6cfc1
27386640.4 ML pegzilarginase-nbln 5 MG/ML InjectionSCDd5ceabf2-43a0-4746-9371-d98a39cf6cfc1
27386551 ML pegzilarginase-nbln 5 MG/ML InjectionSCDd5ceabf2-43a0-4746-9371-d98a39cf6cfc1
2738665Loargys 2 MG per 0.4 ML InjectionSYd5ceabf2-43a0-4746-9371-d98a39cf6cfc1
2738662Loargys 5 MG per 1 ML InjectionSYd5ceabf2-43a0-4746-9371-d98a39cf6cfc1
2738665Loargys 5 MG/ML per 0.4 ML InjectionSYd5ceabf2-43a0-4746-9371-d98a39cf6cfc1
2738662Loargys 5 MG/ML per 1 ML InjectionSYd5ceabf2-43a0-4746-9371-d98a39cf6cfc1
2738664pegzilarginase-nbln 2 MG per 0.4 ML InjectionSYd5ceabf2-43a0-4746-9371-d98a39cf6cfc1
2738655pegzilarginase-nbln 5 MG per 1 ML InjectionSYd5ceabf2-43a0-4746-9371-d98a39cf6cfc1
2738664pegzilarginase-nbln 5 MG/ML per 0.4 ML InjectionSYd5ceabf2-43a0-4746-9371-d98a39cf6cfc1
2738655pegzilarginase-nbln 5 MG/ML per 1 ML InjectionSYd5ceabf2-43a0-4746-9371-d98a39cf6cfc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81583-102-01815830102011 VIAL in 1 CARTON (81583-102-01) / .4 mL in 1 VIAL1 vial2026-03-09NoNoCurrent