Docetaxel

Product NDC
66758-050
11-digit product format
667580050
Labeler code
66758
Product ID
66758-050_4142deb5-9110-4cb8-8319-8a9f1cd04647
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
docetaxel
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc.
Application
NDA201525
Marketing category
NDA
Marketing start
2011-06-29
Substance
DOCETAXEL
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
DOCETAXEL10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15H5577CQD
Rxcui1093280

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
66758-050-01Docetaxel2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION218
66758-050-01Docetaxel1 in 1 CARTONINJECTION, SOLUTION118
66758-050-02Docetaxel1 in 1 CARTONINJECTION, SOLUTION118
66758-050-02Docetaxel8 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION818
66758-050-03Docetaxel1 in 1 CARTONINJECTION, SOLUTION118
66758-050-03Docetaxel16 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1618

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66758-050-01ML - Milliliter66758-05032495a3f-cd25-405e-ab9d-0edbeb02e9c312012-07-24
66758-050-02ML - Milliliter66758-050dcfac960-167e-4c03-a9e3-db60c1bf43f812012-07-24
66758-050-03ML - Milliliter66758-050a9e8f150-4a7b-4aac-8798-0e4a11d68fdc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCETAXELACTIVE INGREDIENT15H5577CQDDOCETAXEL INJECTION, SOLUTION [SANDOZ INC]5
DOCETAXEL ANHYDROUSACTIVE MOIETY699121PHCADOCETAXEL INJECTION, SOLUTION [SANDOZ INC]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MDOCETAXEL INJECTION, SOLUTION [SANDOZ INC]5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDOCETAXEL INJECTION, SOLUTION [SANDOZ INC]5
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQDOCETAXEL INJECTION, SOLUTION [SANDOZ INC]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDOCETAXEL INJECTION, SOLUTION [SANDOZ INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66758-050DOCETAXEL INJECTION, SOLUTION [SANDOZ INC.]18Current NDC, Legacy NDC, 6 package rows20240830_e03d1378-6889-43d5-a34c-f96132cffa88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093280DOCEtaxel 10 MG/ML Injectable SolutionPSNe03d1378-6889-43d5-a34c-f96132cffa8818
1093280docetaxel 10 MG/ML Injectable SolutionSCDe03d1378-6889-43d5-a34c-f96132cffa8818

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66758-050-01667580050011 VIAL, MULTI-DOSE in 1 CARTON (66758-050-01) / 2 mL in 1 VIAL, MULTI-DOSE2011-06-290000-00-00NoNoCurrent
66758-050-02667580050021 VIAL, MULTI-DOSE in 1 CARTON (66758-050-02) / 8 mL in 1 VIAL, MULTI-DOSE2011-06-290000-00-00NoNoCurrent
66758-050-03667580050031 VIAL, MULTI-DOSE in 1 CARTON (66758-050-03) / 16 mL in 1 VIAL, MULTI-DOSE2011-06-290000-00-00NoNoCurrent