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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761211Loargyspegzilarginase-nbln351(a)Rx2026-06-01

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