Docetaxel

Product NDC
23155-904
11-digit product format
231550904
Labeler code
23155
Product ID
23155-904_459836aa-017b-4ba5-a69d-d16824f719fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Docetaxel
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA216677
Marketing category
ANDA
Marketing start
2024-12-15
Substance
DOCETAXEL
Active strength
80 mg/4mL
Pharmacologic classes
Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Docetaxel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCETAXEL80 mg/4mL

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-904-31Docetaxel1 in 1 CARTONINJECTION12
23155-904-31Docetaxel4 mL in 1 VIALINJECTION42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-904-31ML - Milliliter23155-90424d08bae-b8c5-4dec-97d8-787fb753367e12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-904DOCETAXEL INJECTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]1Current NDC, 2 package rows20241218_81686d37-a13f-46e2-b439-a84eb1433634.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1861411DOCEtaxel 160 MG in 8 ML InjectionPSN81686d37-a13f-46e2-b439-a84eb14336342
1860480DOCEtaxel 20 MG in 1 ML InjectionPSN81686d37-a13f-46e2-b439-a84eb14336342
1860485DOCEtaxel 80 MG in 4 ML InjectionPSN81686d37-a13f-46e2-b439-a84eb14336342
18604801 ML docetaxel 20 MG/ML InjectionSCD81686d37-a13f-46e2-b439-a84eb14336342
18604854 ML docetaxel 20 MG/ML InjectionSCD81686d37-a13f-46e2-b439-a84eb14336342
18614118 ML docetaxel 20 MG/ML InjectionSCD81686d37-a13f-46e2-b439-a84eb14336342
1861411docetaxel 160 MG per 8 ML InjectionSY81686d37-a13f-46e2-b439-a84eb14336342
1860480docetaxel 20 MG per 1 ML InjectionSY81686d37-a13f-46e2-b439-a84eb14336342
1860485docetaxel 80 MG per 4 ML InjectionSY81686d37-a13f-46e2-b439-a84eb14336342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-904-31231550904311 VIAL in 1 CARTON (23155-904-31) / 4 mL in 1 VIAL1 vial2024-12-15NoNoCurrent