FDA.reportPublic FDA data

Paclitaxel

Product NDC
25021-255
11-digit product format
250210255
Labeler code
25021
Product ID
25021-255_5f3284c1-d03f-4fca-bb78-1ead3280af60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paclitaxel
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA207326
Marketing category
ANDA
Marketing start
2024-02-01
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
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
25021-255-05Paclitaxel1 in 1 CARTONINJECTION, SOLUTION11
25021-255-05Paclitaxel5 mL in 1 VIALINJECTION, SOLUTION51
25021-255-17Paclitaxel1 in 1 CARTONINJECTION, SOLUTION11
25021-255-17Paclitaxel16.7 mL in 1 VIALINJECTION, SOLUTION16.71
25021-255-50Paclitaxel50 mL in 1 VIALINJECTION, SOLUTION501
25021-255-50Paclitaxel1 in 1 CARTONINJECTION, SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-255-05ML - Milliliter25021-255e3a7c42b-374e-4a5a-8a87-dbcc0e35175f12024-05-16
25021-255-17ML - Milliliter25021-2553b145b0b-5307-4ca6-858d-3a847e0d0a3112024-05-16
25021-255-50ML - Milliliter25021-255083e8ff1-c678-41c0-9d15-a15df3a8906e12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-255PACLITAXEL INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 6 package rows20240201_5721b9bf-c3c1-4b73-b96c-5fbe3147b6a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312199PACLitaxel 6 MG/ML Injectable SolutionPSN5721b9bf-c3c1-4b73-b96c-5fbe3147b6a51
312199paclitaxel 6 MG/ML Injectable SolutionSCD5721b9bf-c3c1-4b73-b96c-5fbe3147b6a51
312199paclitaxel 100 MG per 16.7 ML Injectable SolutionSY5721b9bf-c3c1-4b73-b96c-5fbe3147b6a51
312199paclitaxel 150 MG per 25 ML Injectable SolutionSY5721b9bf-c3c1-4b73-b96c-5fbe3147b6a51
312199paclitaxel 30 MG per 5 ML Injectable SolutionSY5721b9bf-c3c1-4b73-b96c-5fbe3147b6a51
312199paclitaxel 300 MG per 50 ML Injectable SolutionSY5721b9bf-c3c1-4b73-b96c-5fbe3147b6a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-255-05250210255051 VIAL in 1 CARTON (25021-255-05) / 5 mL in 1 VIAL1 vial2024-02-01NoNoHistorical
25021-255-17250210255171 VIAL in 1 CARTON (25021-255-17) / 16.7 mL in 1 VIAL1 vial2024-02-01NoNoHistorical
25021-255-50250210255501 VIAL in 1 CARTON (25021-255-50) / 50 mL in 1 VIAL1 vial2024-02-01NoNoHistorical