Docetaxel

Product NDC
72078-040
11-digit product format
720780040
Labeler code
72078
Product ID
72078-040_8f647874-d9fc-4d8f-98e4-3bf4693e3766
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOCETAXEL ANHYDROUS
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA210848
Marketing category
ANDA
Marketing start
2022-08-03
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
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
72078-040-08Docetaxel8 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION82
72078-040-08Docetaxel1 in 1 CARTONINJECTION, SOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72078-040-08ML - Milliliter72078-040bafe67c4-0902-43ce-8f05-2c279a12350612022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72078-040DOCETAXEL (DOCETAXEL ANHYDROUS) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]2Current NDC, Legacy NDC, 2 package rows20230519_2992d633-08fa-44f3-b14d-41700f24686b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093280DOCEtaxel 10 MG/ML Injectable SolutionPSN2992d633-08fa-44f3-b14d-41700f24686b2
1093280docetaxel 10 MG/ML Injectable SolutionSCD2992d633-08fa-44f3-b14d-41700f24686b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72078-040-08720780040081 VIAL, MULTI-DOSE in 1 CARTON (72078-040-08) / 8 mL in 1 VIAL, MULTI-DOSE2022-08-030000-00-00NoNoCurrent