Docetaxel

Product NDC
25021-245
11-digit product format
250210245
Labeler code
25021
Product ID
25021-245_3897fe0d-2b9f-4be0-9076-9ccd693d4c86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Docetaxel Anhydrous
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA207252
Marketing category
ANDA
Marketing start
2017-09-15
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
Rxcui1860480, 1860485

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
60a22813-7270-4733-af61-30636bce9f0fProduct name420180820
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
0179c4ba-fb03-4931-875d-b4f1ba528029Product name120160107
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9ff92ef8-2da9-4645-bbf8-642e7eb0d754Product name120150812

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-245-01Docetaxel1 mL in 1 VIALINJECTION, SOLUTION110
25021-245-01Docetaxel1 in 1 CARTONINJECTION, SOLUTION110
25021-245-04Docetaxel1 in 1 CARTONINJECTION, SOLUTION110
25021-245-04Docetaxel4 mL in 1 VIALINJECTION, SOLUTION410

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-245-01ML - Milliliter25021-245ec7bef7b-c11f-4a4f-a9f6-da13939d6d7f12018-03-08
25021-245-04ML - Milliliter25021-245929a7588-939f-4d94-8047-cb271af619ee12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-245DOCETAXEL (DOCETAXEL ANHYDROUS) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]9Current NDC, Legacy NDC, 4 package rows20230525_30077f79-341f-4618-9ec5-23b17b212fae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1860480DOCEtaxel 20 MG in 1 ML InjectionPSN30077f79-341f-4618-9ec5-23b17b212fae10
1860485DOCEtaxel 80 MG in 4 ML InjectionPSN30077f79-341f-4618-9ec5-23b17b212fae10
18604801 ML docetaxel 20 MG/ML InjectionSCD30077f79-341f-4618-9ec5-23b17b212fae10
18604854 ML docetaxel 20 MG/ML InjectionSCD30077f79-341f-4618-9ec5-23b17b212fae10
1860480docetaxel 20 MG per 1 ML InjectionSY30077f79-341f-4618-9ec5-23b17b212fae10
1860485docetaxel 80 MG per 4 ML InjectionSY30077f79-341f-4618-9ec5-23b17b212fae10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-245-01250210245011 VIAL in 1 CARTON (25021-245-01) / 1 mL in 1 VIAL1 vial2017-09-150000-00-00NoNoCurrent
25021-245-04250210245041 VIAL in 1 CARTON (25021-245-04) / 4 mL in 1 VIAL1 vial2017-09-150000-00-00NoNoCurrent