PACLITAXEL

Product NDC
67457-937
11-digit product format
674570937
Labeler code
67457
Product ID
67457-937_2e325564-59ba-4a16-86b4-5535cd4b53f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PACLITAXEL
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA217877
Marketing category
ANDA
Marketing start
2025-10-09
Substance
PACLITAXEL
Active strength
100 mg/20mL
Pharmacologic classes
Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PACLITAXEL
Listing expiration
2027-12-31

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
67457-937-50PACLITAXEL20 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-937-50EA - Each67457-9378daebf13-243e-4f9c-a64f-98fafcdd34f112025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
583214PACLitaxel 100 MG InjectionPSNa1a06de1-d9a4-460a-b87d-5e40305b065c3
583214paclitaxel 100 MG InjectionSCDa1a06de1-d9a4-460a-b87d-5e40305b065c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67457-937-506745709375020 mL in 1 VIAL (67457-937-50) 20 ml2025-10-09NoNoHistorical