Docetaxel

Product NDC
43066-044
11-digit product format
430660044
Labeler code
43066
Product ID
43066-044_654319ae-e5f9-4a6a-b566-201923153b6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Docetaxel
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA215744
Marketing category
ANDA
Marketing start
2025-11-27
Substance
DOCETAXEL ANHYDROUS
Active strength
10 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
DOCETAXEL ANHYDROUS10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii699121PHCA
Rxcui1093280, 1860619

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
43066-044-01Docetaxel2 mL in 1 VIAL, SINGLE-DOSEINJECTION21
43066-044-02Docetaxel1 in 1 CARTONINJECTION11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093280DOCEtaxel 10 MG/ML Injectable SolutionPSN654319ae-e5f9-4a6a-b566-201923153b6e1
1860619DOCEtaxel 20 MG in 2 ML InjectionPSN654319ae-e5f9-4a6a-b566-201923153b6e1
18606192 ML docetaxel 10 MG/ML InjectionSCD654319ae-e5f9-4a6a-b566-201923153b6e1
1093280docetaxel 10 MG/ML Injectable SolutionSCD654319ae-e5f9-4a6a-b566-201923153b6e1
1860619docetaxel 20 MG per 2 ML InjectionSY654319ae-e5f9-4a6a-b566-201923153b6e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43066-044-01430660044012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
43066-044-02430660044021 VIAL, SINGLE-DOSE in 1 CARTON (43066-044-02) / 2 mL in 1 VIAL, SINGLE-DOSE (43066-044-01) 2025-11-27NoNoCurrent