Paclitaxel

Product NDC
75007-041
11-digit product format
750070041
Labeler code
75007
Product ID
75007-041_c455b438-d057-4568-a66a-68775a878fdc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paclitaxel (aibumin-bound)
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route
INTRAVENOUS
Labeler
Ningbo Shuangcheng Pharmaceutical Co., Ltd
Application
ANDA216355
Marketing category
ANDA
Marketing start
2025-05-15
Substance
PACLITAXEL
Active strength
100 mg/100mg
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/100mg

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
75007-041-01Paclitaxel1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,15
75007-041-01Paclitaxel100 mg in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
583214PACLitaxel 100 MG InjectionPSN4df3fda6-0b29-420e-ab91-81441ce914ed5
583214paclitaxel 100 MG InjectionSCD4df3fda6-0b29-420e-ab91-81441ce914ed5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
75007-041-01750070041011 in 1 CARTONHistorical