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

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 Identifiers#

Field, Values table
FieldValues
UniiT9FVH03HMZ
Rxcui2121421, 2121426

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

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