Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)

Product NDC
24979-710
11-digit product format
249790710
Labeler code
24979
Product ID
24979-710_72be83ed-81a8-4d5d-abf9-9154e481d840
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paclitaxel
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route
INTRAVENOUS
Labeler
Upsher-Smith Laboratories, LLC
Application
NDA021660
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-04-01
Substance
PACLITAXEL
Active strength
100 mg/20mL
Pharmacologic classes
Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PACLITAXEL100 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP88XT4IS4D
Rxcui583214

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9bfd8626-d4ce-43ae-acb3-8de37f80302fProduct name320260126
2cc1dc98-28db-3a82-b37e-4e50de7c4f94Product name520240102
a05831c4-07a7-44ad-9dc5-89391450ee82Product name120230323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24979-710-51Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,12
24979-710-51Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)20 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-710-51EA - Each24979-71050a6da37-2d63-430e-b321-66be9697a7f312022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-710PACLITAXEL PROTEIN-BOUND PARTICLES FOR INJECTABLE SUSPENSION (ALBUMIN-BOUND) (PACLITAXEL) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, LLC]2Current NDC, Legacy NDC, 2 package rows20250119_1f41135d-3da4-45b2-9462-6482256fa728.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
583214PACLitaxel 100 MG InjectionPSN1f41135d-3da4-45b2-9462-6482256fa7282
583214paclitaxel 100 MG InjectionSCD1f41135d-3da4-45b2-9462-6482256fa7282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24979-710-51249790710511 VIAL, SINGLE-USE in 1 CARTON (24979-710-51) > 20 mL in 1 VIAL, SINGLE-USE2022-04-010000-00-00NoNoCurrent