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 Identifiers#

Field, Values table
FieldValues
Unii7D96IR0PPM
Rxcui213040, 240906

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

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