PACLITAXEL

Product NDC
23155-882
11-digit product format
231550882
Labeler code
23155
Product ID
23155-882_d4a15d93-5bab-4208-aa87-66131fd901cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paclitaxel
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA207326
Marketing category
ANDA
Marketing start
2023-08-31
Substance
PACLITAXEL
Active strength
6 mg/mL
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
Brand name suffix
PACLITAXEL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PACLITAXEL6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP88XT4IS4D
Rxcui312199

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
23155-882-31PACLITAXELPACLITAXEL1 in 1 CARTONINJECTION, SOLUTION13
23155-882-31PACLITAXELPACLITAXEL5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-882-31ML - Milliliter23155-882e4db58bb-9154-41e9-8ba6-f09d44408b6b12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-882PACLITAXEL PACLITAXEL (PACLITAXEL) INJECTION, SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]2Current NDC, 2 package rows20230906_b4c5d08a-e0f5-4af1-97d6-213705adedf1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312199PACLitaxel 6 MG/ML Injectable SolutionPSNb4c5d08a-e0f5-4af1-97d6-213705adedf13
312199paclitaxel 6 MG/ML Injectable SolutionSCDb4c5d08a-e0f5-4af1-97d6-213705adedf13
312199paclitaxel 100 MG per 16.7 ML Injectable SolutionSYb4c5d08a-e0f5-4af1-97d6-213705adedf13
312199paclitaxel 150 MG per 25 ML Injectable SolutionSYb4c5d08a-e0f5-4af1-97d6-213705adedf13
312199paclitaxel 30 MG per 5 ML Injectable SolutionSYb4c5d08a-e0f5-4af1-97d6-213705adedf13
312199paclitaxel 300 MG per 50 ML Injectable SolutionSYb4c5d08a-e0f5-4af1-97d6-213705adedf13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
23155-882-31231550882311 VIAL, MULTI-DOSE in 1 CARTON (23155-882-31) / 5 mL in 1 VIAL, MULTI-DOSE2023-08-31NoNoHistorical