Docetaxel

Product NDC
71288-152
11-digit product format
712880152
Labeler code
71288
Product ID
71288-152_bf235693-ce1a-4f89-b33a-8aaf93efb275
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Docetaxel
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA213768
Marketing category
ANDA
Marketing start
2025-05-13
Substance
DOCETAXEL
Active strength
20 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
Docetaxel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCETAXEL20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15H5577CQD
Rxcui1860480, 1860485

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be52172d-e80b-4aac-aa81-254100bce67fProduct name920260304
c4fcacbc-a699-410c-905b-642c4d134e72Product name120250616
ad3381c5-7539-4a18-83b7-e7382b118d04Product name120231117
60a22813-7270-4733-af61-30636bce9f0fProduct name420180820
0179c4ba-fb03-4931-875d-b4f1ba528029Product name120160107
9ff92ef8-2da9-4645-bbf8-642e7eb0d754Product name120150812

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-152-04Docetaxel4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE47
71288-152-04Docetaxel1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-152DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [MEITHEAL PHARMACEUTICALS INC.]7Current NDC, 2 package rows20250523_f970e352-3d43-4cc4-a859-503ec37b6e22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1860480DOCEtaxel 20 MG in 1 ML InjectionPSNf970e352-3d43-4cc4-a859-503ec37b6e227
1860485DOCEtaxel 80 MG in 4 ML InjectionPSNf970e352-3d43-4cc4-a859-503ec37b6e227
18604801 ML docetaxel 20 MG/ML InjectionSCDf970e352-3d43-4cc4-a859-503ec37b6e227
18604854 ML docetaxel 20 MG/ML InjectionSCDf970e352-3d43-4cc4-a859-503ec37b6e227
1860480docetaxel 20 MG per 1 ML InjectionSYf970e352-3d43-4cc4-a859-503ec37b6e227
1860485docetaxel 80 MG per 4 ML InjectionSYf970e352-3d43-4cc4-a859-503ec37b6e227

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71288-152-04712880152041 VIAL, SINGLE-DOSE in 1 CARTON (71288-152-04) / 4 mL in 1 VIAL, SINGLE-DOSE2025-05-13NoNoCurrent