FDA.reportPublic FDA data

Docetaxel

Product NDC
25021-254
11-digit product format
250210254
Labeler code
25021
Product ID
25021-254_841e3024-e160-4c4b-93d3-1e79d628d95b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Docetaxel Anhydrous
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA213510
Marketing category
ANDA
Marketing start
2023-08-01
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

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
25021-254-08Docetaxel8 mL in 1 VIALINJECTION81
25021-254-08Docetaxel1 in 1 CARTONINJECTION11
25021-254-16Docetaxel1 in 1 CARTONINJECTION11
25021-254-16Docetaxel16 mL in 1 VIALINJECTION161

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-254DOCETAXEL (DOCETAXEL ANHYDROUS) INJECTION [SAGENT PHARMACEUTICALS]1Current NDC, 4 package rows20230801_6b227144-c844-4549-960c-cc3ac5c13b2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093280DOCEtaxel 10 MG/ML Injectable SolutionPSN6b227144-c844-4549-960c-cc3ac5c13b2b1
1093280docetaxel 10 MG/ML Injectable SolutionSCD6b227144-c844-4549-960c-cc3ac5c13b2b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-254-08250210254081 VIAL in 1 CARTON (25021-254-08) / 8 mL in 1 VIAL1 vial2023-08-01NoNoHistorical
25021-254-16250210254161 VIAL in 1 CARTON (25021-254-16) / 16 mL in 1 VIAL1 vial2023-08-01NoNoHistorical