FDA.reportPublic FDA data

ONCASPAR

Product NDC
72694-954
11-digit product format
726940954
Labeler code
72694
Product ID
72694-954_f0a8a9ab-8203-47aa-abbe-54614c201d48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pegaspargase
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Servier Pharmaceuticals LLC
Application
BLA103411
Marketing category
BLA
Marketing start
2020-01-02
Substance
PEGASPARGASE
Active strength
750 [iU]/mL
Pharmacologic classes
Asparaginase [CS], Asparagine-specific Enzyme [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEGASPARGASE750 [iU]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7D96IR0PPMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
213040Internal RxNorm lookup
240906Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ceAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72694-954-01ONCASPAR1 in 1 CARTONINJECTION, SOLUTION113
72694-954-01ONCASPAR5 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72694-954-01ML - Milliliter72694-954356f7136-a524-4573-aa32-4da360e8f8b512020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72694-954ONCASPAR (PEGASPARGASE) INJECTION, SOLUTION [SERVIER PHARMACEUTICALS LLC]13Current NDC, Legacy NDC, 2 package rows20241010_ac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce.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
ONCASPARPEGASPARGASEServier Pharmaceuticals LLCac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce2024-10-07Warnings, Adverse reactionsExact identifier
application number: BLA103411
ndc (product): 72694-954

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103411Oncasparpegaspargase351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213040ONCASPAR 3750 UNT in 5 ML InjectionPSNac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce13
240906pegaspargase 3750 UNT in 5 ML InjectionPSNac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce13
2130405 ML pegaspargase 750 UNT/ML Injection [Oncaspar]SBDac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce13
2409065 ML pegaspargase 750 UNT/ML InjectionSCDac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce13
213040Oncaspar 3750 UNT per 5 ML InjectionSYac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce13
240906pegaspargase 3750 UNT per 5 ML InjectionSYac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72694-954-01726940954011 VIAL, SINGLE-USE in 1 CARTON (72694-954-01) / 5 mL in 1 VIAL, SINGLE-USE2020-01-020000-00-00NoNoCurrent