FDA.reportPublic FDA data

asparlas

Product NDC
72694-515
11-digit product format
726940515
Labeler code
72694
Product ID
72694-515_22da60ef-4135-4bd5-8af1-6d10b7879a0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calaspargase pegol
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Servier Pharmaceuticals LLC
Application
BLA761102
Marketing category
BLA
Marketing start
2019-09-27
Substance
CALASPARGASE PEGOL
Active strength
750 U/mL
Pharmacologic classes
Asparaginase [CS], Asparagine-specific Enzyme [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
asparlas
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALASPARGASE PEGOL750 U/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T9FVH03HMZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2121421Internal RxNorm lookup
2121426Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6585bd0d-bd78-4341-9e87-0f7664821f05Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e78acb14-d3b9-41d7-a29a-78f14f0971ccProduct name120190430

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72694-515-01asparlas5 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION512
72694-515-01asparlas1 in 1 CARTONINJECTION, SOLUTION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72694-515-01ML - Milliliter72694-5157482a74a-8c29-4a73-bfd1-a136fbefb25112019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72694-515ASPARLAS (CALASPARGASE PEGOL) INJECTION, SOLUTION [SERVIER PHARMACEUTICALS LLC]12Current NDC, Legacy NDC, 2 package rows20241011_6585bd0d-bd78-4341-9e87-0f7664821f05.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
asparlasCALASPARGASE PEGOLServier Pharmaceuticals LLC6585bd0d-bd78-4341-9e87-0f7664821f052024-10-08Warnings, Adverse reactionsExact identifier
application number: BLA761102
ndc (product): 72694-515

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761102Asparlascalaspargase pegol-mknl351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2121426ASPARLAS 3,750 UNT in 5 mL InjectionPSN6585bd0d-bd78-4341-9e87-0f7664821f0512
2121421calaspargase pegol-mknl 3,750 UNT in 5 mL InjectionPSN6585bd0d-bd78-4341-9e87-0f7664821f0512
21214265 ML calaspargase pegol-mknl 750 UNT/ML Injection [Asparlas]SBD6585bd0d-bd78-4341-9e87-0f7664821f0512
21214215 ML calaspargase pegol-mknl 750 UNT/ML InjectionSCD6585bd0d-bd78-4341-9e87-0f7664821f0512
2121426Asparlas 3,750 UNT per 5 ML InjectionSY6585bd0d-bd78-4341-9e87-0f7664821f0512
2121426Asparlas 750 UNT/ML per 5 ML InjectionSY6585bd0d-bd78-4341-9e87-0f7664821f0512
2121421calaspargase pegol-mknl 3,750 UNT per 5 ML InjectionSY6585bd0d-bd78-4341-9e87-0f7664821f0512
2121421calaspargase pegol-mknl 750 UNT/ML per 5 ML InjectionSY6585bd0d-bd78-4341-9e87-0f7664821f0512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72694-515-01726940515011 VIAL, SINGLE-USE in 1 CARTON (72694-515-01) / 5 mL in 1 VIAL, SINGLE-USE2019-09-270000-00-00NoNoCurrent