FDA.reportPublic FDA data

Docetaxel

Product NDC
0955-1022
11-digit product format
009551022
Labeler code
0955
Product ID
0955-1022_7c9667b2-3981-4256-a6a5-0c862549f837
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Docetaxel
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Sanofi-Aventis U.S. LLC
Application
NDA020449
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-10-23
Substance
DOCETAXEL
Active strength
160 mg/8mL
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
DOCETAXEL160 mg/8mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15H5577CQD
Rxcui1860480, 1860485, 1861411

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0955-1022-082024-12-09C16284748780-11030e365-64b0-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DOCETAXEL safely and effectively. See full prescribing information for DOCETAXEL. DOCETAXEL injection, for intravenous use Initial U.S. Approval: 1996
0955-1022-082024-07-30C16284748780-11030e365-64b0-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DOCETAXEL safely and effectively. See full prescribing information for DOCETAXEL. DOCETAXEL injection, for intravenous use Initial U.S. Approval: 1996
0955-1022-082024-01-30C16284748780-11030e365-64b0-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use DOCETAXEL safely and effectively. See full prescribing information for DOCETAXEL. DOCETAXEL injection, for intravenous use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0955-1022-08Docetaxel8 mL in 1 VIAL, GLASSINJECTION, SOLUTION, CONCENTRATE830
0955-1022-08Docetaxel1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE130

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0955-1022-08ML - Milliliter0955-1022e0321ba3-2e1f-4640-9d1f-471e1347762412016-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DocetaxelACTIVE INGREDIENT15H5577CQDDOCETAXEL INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S.]11
Docetaxel AnhydrousACTIVE MOIETY699121PHCADOCETAXEL INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S.]11
alcoholINACTIVE INGREDIENT3K9958V90MDOCETAXEL INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S.]11
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDOCETAXEL INJECTION, SOLUTION, CONCENTRATE [WINTHROP U.S.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0955-1022DOCETAXEL INJECTION, SOLUTION, CONCENTRATE [SANOFI-AVENTIS U.S. LLC]30Current NDC, Legacy NDC, 2 package rows20241210_dd0ca36d-1f54-4568-8d19-a7152addcd52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1861411DOCEtaxel 160 MG in 8 ML InjectionPSNdd0ca36d-1f54-4568-8d19-a7152addcd5230
1860480DOCEtaxel 20 MG in 1 ML InjectionPSNdd0ca36d-1f54-4568-8d19-a7152addcd5230
1860485DOCEtaxel 80 MG in 4 ML InjectionPSNdd0ca36d-1f54-4568-8d19-a7152addcd5230
18604801 ML docetaxel 20 MG/ML InjectionSCDdd0ca36d-1f54-4568-8d19-a7152addcd5230
18604854 ML docetaxel 20 MG/ML InjectionSCDdd0ca36d-1f54-4568-8d19-a7152addcd5230
18614118 ML docetaxel 20 MG/ML InjectionSCDdd0ca36d-1f54-4568-8d19-a7152addcd5230
1861411docetaxel 160 MG per 8 ML InjectionSYdd0ca36d-1f54-4568-8d19-a7152addcd5230
1860480docetaxel 20 MG per 1 ML InjectionSYdd0ca36d-1f54-4568-8d19-a7152addcd5230
1860485docetaxel 80 MG per 4 ML InjectionSYdd0ca36d-1f54-4568-8d19-a7152addcd5230

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0955-1022-08009551022081 VIAL, GLASS in 1 CARTON (0955-1022-08) / 8 mL in 1 VIAL, GLASS2016-10-230000-00-00NoNoCurrent