FDA.reportPublic FDA data

Docetaxel

Product NDC
16729-231
11-digit product format
167290231
Labeler code
16729
Product ID
16729-231_6eb31fb5-dae4-45e1-e053-2a91aa0aa5d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Docetaxel
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Accord Healthcare Inc.
Application
NDA201195
Marketing category
NDA
Marketing start
2012-07-01
Marketing end
0000-00-00
Substance
DOCETAXEL ANHYDROUS
Active strength
20 mg/mL
Pharmacologic classes
Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
16729-231-63DOCETAXEL1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE120
16729-231-63DOCETAXEL1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE120
16729-231-64DOCETAXEL4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE420
16729-231-64DOCETAXEL1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE120
16729-231-65DOCETAXEL1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE120
16729-231-65DOCETAXEL8 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE820

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-231-63ML - Milliliter16729-2313c171082-4d27-4103-931a-75a1dba1d95d12013-02-13
16729-231-64ML - Milliliter16729-231c14f8600-b86e-439d-8a0d-841b033ef11912013-02-13
16729-231-65ML - Milliliter16729-231da308e77-3863-490f-8778-f79a7305fd1612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCETAXELACTIVE INGREDIENT15H5577CQDDOCETAXEL KIT DOCETAXEL INJECTION, SOLUTION [ACCORD HEALTHCARE INC.]10
DOCETAXEL ANHYDROUSACTIVE MOIETY699121PHCADOCETAXEL KIT DOCETAXEL INJECTION, SOLUTION [ACCORD HEALTHCARE INC.]10
ALCOHOLINACTIVE INGREDIENT3K9958V90MDOCETAXEL KIT DOCETAXEL INJECTION, SOLUTION [ACCORD HEALTHCARE INC.]10
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDOCETAXEL KIT DOCETAXEL INJECTION, SOLUTION [ACCORD HEALTHCARE INC.]10
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQDOCETAXEL KIT DOCETAXEL INJECTION, SOLUTION [ACCORD HEALTHCARE INC.]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDOCETAXEL KIT DOCETAXEL INJECTION, SOLUTION [ACCORD HEALTHCARE INC.]10
WATERINACTIVE INGREDIENT059QF0KO0RDOCETAXEL KIT DOCETAXEL INJECTION, SOLUTION [ACCORD HEALTHCARE INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-231DOCETAXEL INJECTION, SOLUTION, CONCENTRATE DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [ACCORD HEALTHCARE INC.]20Legacy NDC, 6 package rows20240816_f59f7811-70b7-4c44-99f7-4f4fdce3ed22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1001405DOCEtaxel 20 MG/ML Injectable SolutionPSNf59f7811-70b7-4c44-99f7-4f4fdce3ed2220
1001405docetaxel 20 MG/ML Injectable SolutionSCDf59f7811-70b7-4c44-99f7-4f4fdce3ed2220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
16729-231-63167290231631 in 1 CARTONHistorical
16729-231-64167290231644 mL in 1 VIAL, SINGLE-DOSE4 mlHistorical
16729-231-65167290231651 in 1 CARTONHistorical