DOCETAXEL

Product NDC
16729-267
11-digit product format
167290267
Labeler code
16729
Product ID
16729-267_1fbda3cb-1ba1-490d-e063-6294a90a6777
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
2013-05-30
Substance
DOCETAXEL ANHYDROUS
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
DOCETAXEL ANHYDROUS20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii699121PHCA
Rxcui1001405

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
16729-267-63DOCETAXEL1 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION, CONCENTRATE120
16729-267-63DOCETAXEL1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE120
16729-267-64DOCETAXEL1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE120
16729-267-64DOCETAXEL4 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION, CONCENTRATE420
16729-267-65DOCETAXEL8 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION, CONCENTRATE820
16729-267-65DOCETAXEL1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE120

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-267-63ML - Milliliter16729-26732121d08-2933-408f-b001-87fa541e32f612013-07-02
16729-267-64ML - Milliliter16729-26711ddd60a-5d0b-42d0-8b57-c81506eee26212013-07-02
16729-267-65ML - Milliliter16729-267351e15fd-8dff-4c72-910f-d8fe72162dd612013-07-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-267DOCETAXEL INJECTION, SOLUTION, CONCENTRATE DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [ACCORD HEALTHCARE INC.]20Current NDC, Legacy 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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-267-63167290267631 VIAL, MULTI-DOSE in 1 CARTON (16729-267-63) / 1 mL in 1 VIAL, MULTI-DOSE2013-10-220000-00-00NoNoCurrent
16729-267-64167290267641 VIAL, MULTI-DOSE in 1 CARTON (16729-267-64) / 4 mL in 1 VIAL, MULTI-DOSE2013-08-020000-00-00NoNoCurrent
16729-267-65167290267651 VIAL, MULTI-DOSE in 1 CARTON (16729-267-65) / 8 mL in 1 VIAL, MULTI-DOSE2013-05-300000-00-00NoNoCurrent